Improving Communication for Cancer Treatment: Addressing Concerns of Older Cancer Patients and Caregivers
Phase: NA
Conditions: Adult Solid Neoplasm, Lymphoma
Sponsor: Supriya Mohile

 
Improving Communication for Cancer Treatment: Addressing 
Concerns of Older Cancer Patients and Caregivers 
 
Protocol #: URCC 13070 
URCC / University of Rochester NCORP Research Base 
NCT02107443 
 
Study Chairs: 
 
 
 
 
 
 
Co-Principal Investigators 
 
Supriya Mohile, MD, MS 
James P. Wilmot Cancer Institute 
URCC NCORP Research Base 
601 Elmwood Avenue, Box 704 
Rochester, NY 14642 
(585) 275-5513 
 
William Dale, MD, PhD 
Arti Hurria, MD 
 
Research Base Co-Chairs 
 
 
Co-investigators 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Statistics Co-Chair 
 
Gary Morrow, PhD, MS 
Karen Mustian, PhD, MPH 
 
Beverly Canin, Patient Advocate 
Gary Morrow, PhD, MS 
Karen Mustian, PhD, MPH 
Marie Flannery, PhD, RN 
Ronald Epstein, MD 
David Dougherty, MD 
Ekaterina (Katia) Noyes, PhD 
Mohamed Tejani, MD 
Robert Gramling, MD 
Paul Duberstein, PhD 
Arti Hurria, MD 
William Dale, MD, PhD 
Rita Gorawara-Bhat,PhD 
Judith Hopkins, MD 
 
Charles Heckler, PhD 
  
Concept submitted to NCI 8/14/13 
Concept resubmitted to NCI 9/27/13 
Concept submitted to NCI 12/18/13 
Concept approved 1/17/14 
Protocol submitted to NCI 2/7/14 
Protocol approved w/ comments 3/5/14 
Amendment submitted to NCI 3/26/14 
Amendment approved w/ comments 4/1/14 
Amendment submitted to NCI 4/2/14 
 NCI approved: 4/8/14 
Amendment submitted to NCI: 11/1/14 
Amendment submitted to NCI: 4/25/17 

URCC13070 Protocol 2017-04-25 
    
Page 2 of 56 
PROTOCOL CONTACT INFORMATION 
 
URCC NCORP Research Base: 
URCC NCORP Research Base  
Saunders Research Building 
265 Crittenden Blvd 
Box CU 420658 
Rochester, NY 14642 
 
phone: 
585-275-5513 
fax: 
585-461-5601 
website: http://extranet.urmc.rochester.edu/NCORP/ 
 
Principal Investigators: 
 
Supriya Mohile, MD, MS 
 
URCC NCORP Research Base  
William Dale, MD, PhD 
    University of Chicago 
Arti Hurria, MD 
 
City of Hope Cancer Center 
Co-Investigators: 
 
Beverly Canin, Patient Advocate 
Gary Morrow, PhD, MS 
Karen Mustian, PhD, MPH 
Marie Flannery, PhD, RN 
        URCC NCORP Research Base 
Ronald Epstein, MD 
David Dougherty, MD 
Ekaterina (Katia) Noyes, PhD 
Mohamed Tejani, MD 
Robert Gramling, MD 
Paul Duberstein, MD 
         University of Rochester 
 
 
 
Rita Gorawara-Bhat, PhD 
 
University of Chicago 
Judith Hopkins, MD 
 
SCCC-Upstate NCORP Community Site 
Biostatistician:  
 
Charles Heckler, PhD 
URCC NCORP Research Base  
Regulatory Contact: 
Cathy Lesniewski 
585-275-2282 
cathleen_lesniewski@urmc.rochester.edu 
Protocol Contact: 
Libby Nagalski 
585.275.1364 
elizabeth_nagalski@urmc.rochester.edu 
Program Managers: 
 
 
 
 
 
 Senior Program Manager  
Nikesha Gilmore, PhD 
585-275-1275 
Nikesha_gilmore@urmc.rochester.edu 
Megan Wells, MPH 
585-275-1277 
Megan_wells@urmc.rochester.edu 
Sandy Plumb 
585-275-1378 
sandy_plumb@urmc.rochester.edu 
 
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 3 of 56 
Table of Contents 
STUDY SCHEMA AND SUMMARY ....................................................................................................................... 4 
1.  BACKGROUND INFORMATION ...................................................................................................................... 5 
2.  STUDY OBJECTIVES ........................................................................................................................................ 12 
3.  STUDY DESIGN .................................................................................................................................................. 13 
4.  PARTICIPANT ELIGIBILITY ......................................................................................................................... 13 
5.  IDENTIFICATION, RECRUITMENT, AND CONSENT PROCEDURES .................................................. 14 
6.  REGISTRATION ................................................................................................................................................ 16 
7.  OUTCOMES ........................................................................................................................................................ 18 
8.  MEASURES TO BE COLLECTED .................................................................................................................. 21 
9.  NCORP SITE RANDOMIZATION ................................................................................................................... 23 
10. INTERVENTION OVERVIEW FOR PHYSICIANS ..................................................................................... 24 
11.  OUTLINE OF STUDY-SPECIFIC PROCEDURES ...................................................................................... 25 
11.1.  PROCEDURES PRIOR TO SCREENING VISIT ..................................................................................................... 26 
11.2.  SCREENING:  VISIT 0 .................................................................................................................................... 26 
11.3.  BASELINE:  VISIT 1....................................................................................................................................... 27 
11.4.  FOLLOW-UP VISITS ........................................................................................................................................ 29 
11.5.  TELEPHONE TEAM CALL (1 TO 7 DAYS FROM BASELINE) .............................................................................. 29 
12.  REIMBURSEMENT ......................................................................................................................................... 30 
13. ADVERSE EVENT REPORTING .................................................................................................................... 30 
14.  CRITERIA FOR WITHDRAWAL .................................................................................................................. 31 
15.  STATISTICAL PLAN ....................................................................................................................................... 32 
16.  DATA MANAGEMENT AND QUALITY ASSURANCE ............................................................................. 35 
17. DATA COLLECTION AND MEASURES ....................................................................................................... 37 
18.  SUBJECT CONSENT AND PEER JUDGMENT .......................................................................................... 37 
19.  RECORD AND DATA RETENTION.............................................................................................................. 37 
20.  REFERENCES ................................................................................................................................................... 38 
 
 
Appendix X-1: Measures 
Appendix X-2: Study Related Forms 
Appendix X-3:  Patient Assessments 
Appendix X-4:  Clinical Research Associate Materials 
Appendix X-5:  Oncology Physician Assessments 
Appendix X-6:  Caregiver Assessments 
Appendix X-7:  Telephone Team Materials 
Appendix X-8:  Coding Procedures 
 

URCC13070 Protocol 2017-04-25 
    
Page 4 of 56 
STUDY SCHEMA AND SUMMARY 
 
 
This study will evaluate whether a standardized geriatric assessment (GA)i administered through a novel web-
based approach can facilitate communication of age-related problems that could influence outcomes important to 
the older cancer patient and his/her caregivers.ii  Adults, age > 70 with an advanced solid tumor malignancy in the 
University of Rochester Cancer Center NCI Community Oncology Program (URCC NCORP) network will be 
eligible.  Oncology physicians who practice at sites within the URCC NCORP network are eligible to participate in 
the study and will be enrolled.  Their eligible patients will then undergo the informed consent process; those 
patients who agree to participate in this study will undergo a clinical assessment consisting of sociodemographic 
characteristics and GA.  Eligible patients should choose one caregiver to participate.   
 
 NCORP practice sites with IRB approval of the protocol will be randomized to receipt of GA plus GA-driven 
recommendations (Arm 1) or usual care (Arm 2).  A NCORP practice site will be defined as any practice location 
within an overarching NCORP designation where oncology physicians and study staff work independently (e.g., 
do not cross over into another practice site).  In Arm 1, oncology physicians, patients, and caregivers will be 
provided with GA summary plus targeted recommendations (i.e., GA-driven recommendations). In Arm 2, patients 
will complete GA, but no GA summary or GA-driven recommendations will be provided to the oncology teams 
except for information regarding clinically significant cognitive impairment and/or depression.  A brief follow-up 
GA will be collected at 4-6 weeks, 3 months, and 6 months after baseline registration. 
 
In both arms, the first office visit with the oncology physician after GA will be audio-recorded (to measure number 
of concerns brought up by patients and caregivers and whether they were addressed by their oncology physicians), 
and measures of quality of life and satisfaction will be collected at 4-6 weeks, 3 months, and 6 months after 
baseline registration.  The primary outcome, patient satisfaction regarding communication about age-related issues 
as measured by a modified Health Care Climate Questionnaire (HCCQ), will be obtained via a phone call 
                                                 
i Geriatric assessment (GA) is a compilation of survey-based and assessment tools to assess geriatric domains such as 
comorbidity, functional status, nutrition, physical performance, cognition, and social support, which measures aging related 
issues that can affect the quality of life of an older patient with cancer.  GA can better predict tolerance to cancer treatment and 
adds important age-related information that is not routinely captured by oncologists. 
 
ii For purposes of this study, a caregiver is defined as a valued and trusted person in a patient’s life who is supportive in health 
care matters by providing valuable social support and/or direct assistive care. The caregiver accompanies the patient to 
medical appointments, is able to listen and give thoughtful advice and may be a family member, partner, friend, or 
professional caregiver.  

URCC13070 Protocol 2017-04-25 
    
Page 5 of 56 
administered by trained personnel, the Telephone Team, who are blinded to group assignment, within 1 to 7 days 
of the baseline audio-recorded clinic consultation, hereby referred to as the Telephone Team Call.  If a telephone 
call is not feasible, the HCCQ will be mailed with a return envelope provided.  Caregivers will complete measures 
of satisfaction, and caregiver burden (both health and economic) at the same time points.  However, caregivers will 
not receive the Telephone Team Call. 
 
A total of 528 patients and 528 caregivers (maximum) will be enrolled in the study. 
 
The acronym for this study is COACH, which stands for Communication On Aging and Cancer Health. 
 
1.  BACKGROUND INFORMATION  
 
1.1. Intervention to be Studied 
The URCC NCORP Research Base will conduct a cluster randomized study evaluating whether providing a GA 
summary with targeted recommendations (i.e., GA-driven recommendations) to older patients with advanced 
cancer, their caregivers, and their oncology physicians can improve patient satisfaction with communication 
about age-related issues and concerns.  Secondary aims will determine if the intervention increases discussions 
about age-related issues during a clinic consultation, improves patient-reported quality of life, and improves 
caregiver burden and caregiver satisfaction with communication.1,2   
 
1.2.  Background and Significance 
Older adults with cancer and their caregivers are presented with complex information regarding the risks and 
benefits of treatment for advanced cancer, but age-related concerns and outcomes are not usually discussed.3  
Outcomes important to the older adult with cancer include not only tumor shrinkage and progression-free survival 
(which are traditionally measured in clinical trials), but also the effect of treatment on health-related quality of life 
(HRQoL) and geriatric domains.3  Our preliminary data with older patients with advanced cancer and their 
caregivers demonstrates that the vast majority want information on how cancer treatment can affect geriatric 
domains (e.g., independence, mood, cognition).  Our preliminary data has also shown that incorporating GA, a 
validated patient-centered approach to the assessment of underlying health status, into the clinical decision making 
process for older patients with cancer is feasible and helps to identify conditions (normally overlooked in routine 
oncology care) that are rated as very important to older patients and caregivers.4-7 Common assessment instruments 
in oncology such as performance status do not address critical domains that affect patient-centered outcomes, 
morbidity, and mortality in the older patient.8  Significant gaps in knowledge regarding cancer treatment in older 
and/or vulnerable adults led to the formation of the Cancer and Aging Research Group (CARG),9 a coalition of 
geriatric oncology researchers and older patient advocates, working together towards improving clinical care for 
older adults with cancer.  In 2010, CARG received a U13 grant (U13 AG038151), in collaboration with the NCI 
and NIA, to conduct and disseminate findings from 3 conferences over 5 years on “Geriatric Oncology Research to 
Improve Clinical Care.”3,8,10  The first U13 conference identified the need to incorporate GA into clinical care to 
facilitate communication regarding the risks and benefits of cancer treatment for older patients with cancer plus 
other age-related health status conditions.8  
 
1.3.  Condition to be Studied  
A growing population of older patients is at high risk 
for adverse outcomes from cancer treatment.  Cancer 
is a disease of aging; approximately 60% of all 
cancers and 70% of cancer mortality occur in persons 
aged 65 years and over.11  The number of cancer 
patients over the age of 65 is projected to significantly 
increase over the next 20 years (see Figure 1).12  
Aging is a highly individualized process, 
characterized by an increased prevalence of health 
status conditions that can affect decision making for 
cancer treatment, treatment tolerance, and ultimately 
outcomes.3,13,14 The PI has shown that older adults 
Figure 1:  Increase in older patients with cancer 

URCC13070 Protocol 2017-04-25 
    
Page 6 of 56 
with cancer have a high prevalence of comorbidity, disability, and geriatric syndromes.15,16  The majority of older 
patients with cancer are treated based on extrapolations of evidence derived from clinical trials providing data on 
the safety and efficacy of treatment in younger adults or in older patients who are fit without other health status 
conditions.17  
 
1.4.  Geriatric Assessment (GA) 
GA is a validated mechanism to obtain patient-reported information about issues important to the older adult 
including function (i.e., ability to remain independent in self-care and community), psychological status, cognitive 
abilities, social support, and the impact of medical problems on quality of life.  In our team’s research, geriatric 
domains captured on GA are the most important outcomes for older patients with cancer, more so than traditional 
oncology outcomes (such as tumor response, progression-free survival).  The results from our pilot work with 
patients and caregivers (see Preliminary Data, Table 1) are consistent with another study that demonstrated that 
older patients may forgo life-sustaining measures if they will have a significant impact on function and cognition.18 
 
1.5.  Geriatric Assessment Components and Relevance to Older Patients with Cancer  
GA provides valuable information that could identify and help address the concerns of older patients with cancer 
and their caregivers.  A description of each GA domain and its relevance to the older patient with cancer is 
provided below. 
 
1.5.1.  Functional Status and Physical Performance:  The need for functional assistance (measured by 
ability to complete activities of daily living) is predictive of chemotherapy toxicity and survival.19-22 Physical 
performance measures objectively evaluate mobility and fall risk.23,24 Falls are common in cancer patients and 
predictive of adverse outcomes.1,16,25  
 
1.5.2.  Comorbidity and Polypharmacy:  Among patients with cancer, comorbidity is associated with poorer 
overall survival.26-30  Comorbidity impacts cancer treatment tolerance.31-34  Furthermore, these comorbid 
conditions may predispose patients to the risks of polypharmacy and drug interactions.35 
 
1.5.3.  Nutrition:  Poor nutritional status is associated with an increased need for functional assistance and 
poorer overall survival in the geriatric population.36  Unintentional weight loss during the 6 months prior to 
chemotherapy is associated with lower chemotherapy response rates and lower overall survival.37  
1.5.4.  Cognition:  A cognitive assessment is needed to determine if the patient has the decisional capacity to 
consent and adhere to supportive care medication instructions and understand the indications to seek attention.  
In the presence of cognitive impairment, the involvement of the patient’s family or caregiver is required to 
maintain safety.38-41 
 
1.5.5.  Psychological State and Social Support:  In a study of older adults with cancer, significant distress 
was identified in 41% of older adults, and poorer physical function correlated with higher distress.41  In both 
the geriatric and oncology literature, social isolation has been linked to an increased risk of mortality.42-44    
 
The evidence suggests that although underlying health status issues and deficits in geriatric domains correlate 
directly with toxicity of therapy and patient-centered outcomes, these considerations are not addressed in routine 
oncology clinical care.3,8 Although the commonly used Karnofsky Performance Status (KPS) and Eastern 
Cooperative Oncology Group (ECOG) performance status (PS) measures do correlate with treatment toxicity, 
these tools were validated in younger groups of patients and do not reliably predict outcomes in older adults with 
cancer.45-47 GA, a compilation of validated tools to assess geriatric domains such as comorbidity, functional status, 
nutrition, physical performance, cognition, and social support, can help define the “stage of aging.”48 GA can better 
predict tolerance to treatment2,49,50 and adds important age-related information that are not captured by traditional 
PS assessment tools utilized in oncology.51  A CARG study (Hurria and Mohile, et al.) found that several GA 
variables predicted severe chemotherapy toxicities in older patients.1  GA has also shown to predict overall 
survival in older cancer patients.52  Studies have found that oncology physicians will modify treatment decisions 
based on GA results when information is provided to them.5,53 Our research team has found the GA proposed in 
this study is feasible in oncology clinics and trials.1,7,54  Unfortunately, clinical trial data that dictate evidence-based 
care for patients with cancer, the majority of whom are older with additional health status considerations, have not 

URCC13070 Protocol 2017-04-25 
    
Page 7 of 56 
generally included GA.  Successful completion of this research has the potential to incorporate communication of 
GA results into the clinical care of older adults with advanced cancer.   
 
1.6.  Gap in Knowledge 
There is a critical gap in knowledge regarding how to improve communication about age-related concerns 
between older adults with cancer, their caregivers, and oncology physicians.54-56 The use of health-related 
quality of life (HRQoL) assessments in clinical practice has been shown to monitor disease and treatment, 
improve the delivery of care, and detect physical or psychosocial problems that otherwise might be 
overlooked.57,58  For example, Detmar et al. showed that providing physicians and patients with summaries of 
patient-reported HRQoL information increased discussions and improved management of HRQoL issues in 
patients with cancer undergoing chemotherapy.  Similarly, important patient-reported information obtained from 
GA could help oncology physicians address age-related concerns of patients and their caregivers thereby 
improving satisfaction with communication and HRQoL.  Despite the fact that the majority of cancer patients are 
aged 70 and over, most oncology physicians have received little training in the care of older patients.9 As a result, 
common problems facing an aging population of cancer patients may go unrecognized and produce serious 
consequences.10,55 Identification of age-related concerns may also facilitate discussions about prognosis, which is 
important because many patients do not understand that cancer treatment is not curative in the setting of advanced 
cancer and can negatively affect quality of life.59  Although GA predicts risk from cancer treatment and survival in 
older patients with cancer, there is no evidence-based approach regarding the use of GA to improve 
communication during the decision making process for cancer treatment.  The hypothesis of this research proposal 
is that providing older patients with cancer, their caregivers, and oncology physicians with a summary of GA 
information and recommendations can improve patient satisfaction with communication about age-related health 
concerns, improve observed communication of age-related concerns captured with audio-recordings of clinic 
encounters of older patients, caregivers, and oncology physicians, and improve patient-reported quality of life.   
 
1.7.  Geriatric Assessment-Driven Recommendations and Relevance to Older Patients with Cancer and 
Caregivers 
We hypothesize that providing information on GA and recommendations to oncology physicians can improve 
patient-reported outcomes such as HRQoL, which is similar to an approach showing that an early palliative care 
intervention improved outcomes of patients with advanced lung cancer.60  Interventions guided by GA have 
positive effects on health outcomes including prevention of disability and reduction in the risk of falls, unplanned 
hospitalizations, and nursing home admissions.3,61-63 Several studies have shown that the implementation of GA-
driven recommendations into the clinical care of older patients with cancer is feasible.4-7  The ELCAPA study 
illustrated that providing GA information to oncology teams can influence treatment decisions, although outcomes 
from these interventions were not measured in this study.5  Another pilot study showed that GA affected the 
oncology treatment plan.53  In a study by McCorkle et al.,64 geriatric nurse practitioners conducted GA with cancer 
patients, which led to a survival advantage (67% in the intervention group compared with 40% in the control 
group) and improved HRQoL.  In a study by Goodwin et al., breast cancer patients in the GA-driven 
recommendations group were significantly more likely to return to normal functioning than controls.65  Different 
approaches for chemotherapy selection and dosing for older and/or frail patients are supported by the literature and 
are incorporated into the framework as GA-driven recommendations.  For example, the FOCUS-2 trial found that 
chemotherapy for advanced colorectal cancer was safe and efficacious in the older and/or frail patient if started at a 
20% dose reduction with escalation as tolerated.66 The GA and recommendations utilized in this proposal have 
been developed through preliminary work, extensive review of the evidence, and clinical expertise of the geriatric 
oncology physicians on the research team.   
 
1.8.  Preliminary Data 
The investigative team is poised to build upon a considerable body of prior work.  The research team has 
conducted studies that have demonstrated the high prevalence of health status issues that could influence cancer 
outcomes in older patients.15,16 They have developed a GA tool for older persons with cancer and the feasibility of 
this tool has been studied in hundreds of cancer patients in multicenter clinical trials.1,7,54 They have collaborated 
on a prospective multicenter study to quantify the risks of chemotherapy among older adults with cancer.1  Dr. 
Mohile has pilot-tested GA and GA-driven interventions with 200 patients from her geriatric oncology clinic.71  
Drs. Mohile, Epstein, and Dale have experience in the study of communication in oncology.  Other investigators 

URCC13070 Protocol 2017-04-25 
    
Page 8 of 56 
lend significant interdisciplinary expertise and stakeholders (CARG, an advisory board of older patients with 
cancer, advocates and caregivers, and community oncology physicians) have provided significant input at all 
stages of preliminary work.   
 
Of importance, Dr. Ron Epstein and Dr. Mohile collaborate on a NCI-funded study (R01 NIH/1R01CA140419-
01A1), which evaluates whether a communication coaching intervention that targets oncology physicians, patients 
and caregivers improves discussions regarding prognosis and treatment choices in advanced cancer.  The primary 
outcome for this study (physician communication behaviors) was obtained from clinic consultations that are audio-
recorded.  The patients (n=81 older patients) also completed a measure of patient satisfaction (Health Care Climate 
Questionnaire), which provided preliminary data for sample size calculations for the current proposal as the 
primary outcome.   
 
1.8.1.  Prevalence of Health Status Issues in Older Patients with Cancer.  Using a nationally representative 
population-based database, Mohile and collaborators published two investigations that demonstrated that 
disability, comorbidity, and geriatric syndromes are more common in cancer patients than in those without 
cancer and that cancer was independently associated with having these conditions.15,16 In addition, Drs. Hurria 
and Mohile have collected GA data from over 500 older cancer patients receiving chemotherapy at 7 
institutions.1  The assessment revealed a number of findings that would not have been detected from a visit’s 
routine history and physical exam.  For example, 41% of patients needed assistance with instrumental 
activities of daily living despite a mean physician-reported KPS of 85 out of 100; 16% had recent falls, and 6% 
had severe cognitive impairment on the cognitive screening test.  
 
1.8.2.  Feasibility of a Geriatric Assessment for Older Adults with Cancer.7,54 The geriatric and oncology 
literature was reviewed to choose validated GA measures.  Selection criteria included reliability, validity, 
brevity, the ability to self-administer, and the ability to prognosticate risk for morbidity or mortality in an older 
patient.7 The final selection of measures was approved by the Cancer and Leukemia Group B (CALGB) 
Cancer in the Elderly and Quality of Life Committees.  The initial feasibility study of this tool was conducted 
in a multicenter study by Dr. Hurria and Dr. Mohile.  Forty patients (mean age 74, range 65 to 87) with cancer 
participated in the study.  The GA was feasible, as demonstrated by a mean time to completion of 27 minutes; 
90% of patients were satisfied with the questionnaire length, and 78% were able to complete it on their own.7 
Subsequently, CALGB 360401 evaluated the feasibility of incorporating the GA into oncology cooperative 
group trials for older adults (n=93).54  The GA results met the protocol-specified feasibility criteria for use in 
the cooperative group.  
 
1.8.3.  Can the Geriatric Assessment Predict Chemotherapy Toxicity?1 The primary objective of Drs. 
Hurria and Mohile’s  previous study was to determine if GA measures predicted grade 3-5 toxicity (severe) 
using the NCI Common Terminology Criteria for Adverse Events (CTCAE, V3.0).  Among the 500 enrollees, 
the mean age was 73 years (range 65-91); 61% had metastatic disease and 71% received 1st line 
chemotherapy.  Grade 3-5 toxicity occurred in 53% (50% grade 3, 12% grade 4, 2% grade 5).  Risk factors for 
severe toxicity included:  1) age ≥ 73, 2) cancer type (GI or GU), 3) standard dose, 4) poly-chemotherapy and 
the following GA measures, 5) falls in the last 6 months, 6) assistance with instrumental activities of daily 
living, and 7) decreased social activity.   
 
1.8.4.  Feasibility of Intervention Proposed in the Study, Contribution of Stakeholders, and Impact on 
Clinical Care.71  Dr. Mohile directs a referral-based consultative Specialized Oncology Care in the Elderly 
(SOCARE) clinic which has collected pilot data on patient preferences, outcomes, and GA-driven 
interventions in over 200 older patients with cancer (Table 1).71  All measures and the GA intervention in this 
proposal are utilized within the SOCARE clinic.  Patients were referred to the clinic by their primary oncology 
team.  As routine in the clinic, each patient completes GA by paper and pencil, and summaries of results are 
provided to the patient and his/her caregivers.  Ratings of each GA domain and acceptability/understanding of 
the GA summaries are assessed.  GA-driven recommendations, developed by the SOCARE team, are provided 
to the referring oncology physician, the patient, and his/her caregivers.  Patient characteristics:  Mean age was 
82.1 (70-95) and 75% had advanced disease.  GA revealed 68% with functional impairment; 70% had >3 
significant comorbidities; 39% had poor nutrition;72 26% screened positive for depression;73 59% reported 

URCC13070 Protocol 2017-04-25 
    
Page 9 of 56 
inadequate social support; 20% had an abnormal cognition screen (but had decision making capacity);74 34% 
had recently fallen, and 60% had poor physical performance.23,75 Acceptability of summaries:  We have 
developed and revised the GA summaries based on extensive qualitative and written feedback from the 
patients and their caregivers.  The summaries include a description of the test used to assess the domain in lay 
language, an interpretation of the score for each domain, and a list of interventions to consider if the score 
signifies impairment.  Acceptability of GA-driven recommendations:  On average, 80% of the GA-driven 
recommendations were implemented by the referring oncology physician with an average of 6 interventions 
per patient (range 3-15).   
 
1.8.5.  The research team has experience with the assessment of patient-physician communication (using 
audio-recordings, surveys, and chart reviews) in the setting of advanced cancer.  Dr. Epstein, an expert in 
patient-centered communication and co-investigator on this study, has conducted multi-method research to 
study patient-physician interactions using analyses of patient and physician surveys and medical record 
audits.76  His research team has helped to establish that patient-centered communication is associated with 
improved information exchange, reduced symptom burden, lower health-care costs, and greater patient 
involvement in decision making.77-79  The measures to assess decision making in Dr. Epstein’s NCI-funded 
RO1 (Dr. Mohile is a co-investigator) have been adapted for patients with advanced cancer.67,68   
Using two trained coders, we examined the audio-recorded interactions between the older patients (n=32) with 
advanced cancer and their oncology physicians (at 8 different sites) to assess number of discussions related to 
geriatric domains brought up by patient and/or caregiver that were addressed by the oncology physician and 
the number of “missed opportunities” (i.e., concerns brought up by patients and caregivers that were not 
adequately addressed by the oncology physician).  We found that at baseline, there were 26 discussions and 26 
missed opportunities among 32 audio-recorded visits.  Fifty percent of visits had 0 age-related discussions; the 
median was 1 (range 1-3).  The majority of missed opportunities were related to functional ability (e.g., not 
taking medicines correctly), physical functioning (e.g., inability to climb stairs, falls), social support (e.g., 
difficulty getting to appointments), and medications (e.g., polypharmacy, drug interactions).  This study was 
not elderly specific and did not incorporate GA (which can identify deficits as described above), but the results 
provide an estimate of the baseline number of discussions about age-related issues that occur in usual care 
within oncology.  We were able to utilize this data to help gather usual care information to inform our analytic 
plan.   
 
Dr. Dale, Chief of Geriatrics and Palliative Care at the University of Chicago, has expertise in medical 
decision making, quality of life, and frailty and has studied the role of emotions in decisions about screening, 
diagnosis, and treatment of cancer in older persons.  He and Dr. Mohile have collaborated on a study that 
evaluated patient-physician decisions with regard to the treatment of advanced prostate cancer.80  His team, 
including Rita Gorawara-Bhat, a senior staff scientist with expertise in qualitative methods (in-depth 
interviewing, cognitive interviewing, focus groups, Delphi techniques, etc.) and survey methods (questionnaire 
design), has significant expertise in the administration and collection of patient-reported outcomes via 
telephone.  The University of Chicago team, which is funded through a PCORI subcontract, will be blinded to 
group assignment and will be able to administer and collect the primary aim as the Telephone Team.  
 
1.9.  Conceptual Model Highlighting Relevance of Topic to Older Patients and Caregivers.  
In 2007, the NCI published a monograph, co-authored by Drs. Epstein and Street, Patient-Centered 
Communication in Cancer Care, which reviewed 2200 relevant communication studies.67  The monograph 
includes a conceptual framework that has been adapted for this study (Figure 2). 
 
1.9.1.  Patient-centered care.  Patient-centered care considers the patient’s unique experience of illness as 
equal in importance to the physician’s disease/diagnostic perspective; it directs clinicians to see the world 
both through the patient’s eyes as well as through a clinical lens.68,69 There is general agreement that patient-
centered care:  1) explores and validates patients’ individual experiences of suffering and their needs, 
expectations and values; 2) offers patients opportunities to provide input into and participate in their care; and 
3) enhances partnership, shared understanding, and trust in the patient-physician relationship. 
 

URCC13070 Protocol 2017-04-25 
    
Page 10 of 56 
1.9.2.  Communication is a process of mutual influence and interaction.  The proposed study is based on 
the Street/Epstein “Ecological Model” of patient-centered communication.70 It is an interactional model.  In 
health-care settings, effective communication is characterized by:   
 
1.9.2a.  Informed, activated, participatory, and communicative patients and caregivers.  Activated 
patients and caregivers express their concerns and participate actively in decisions. Providing GA 
information to patients and their caregivers could facilitate “activation.”  We will measure participation in 
the encounter through direct observation and measure the quality of the patient-clinician relationship using 
surveys. 
 
1.9.2b.  Informed, receptive, patient-centered, and communicative clinicians.  Clinician patient-
centered behaviors include organizing the visit to elicit patients’ concerns, raising issues often ignored in 
clinical consultations, and responding to patients’ concerns with information and empathy.  We can 
observe the degree to which oncology physicians explore and validate patients’ and caregivers’ concerns 
about age-related conditions.  Patients and caregivers will report on the degree to which they felt included 
in discussions regarding their care. 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 11 of 56 
Figure 2:  Conceptual Model 
1.9.2c.  A health-care system that provides accessible, well-organized, and responsive health services 
that are tailored to the patient’s needs.  For example, greater access to services that address age-related 
issues may improve outcomes.  We will measure this dimension via patient/caregiver surveys. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.10.  Study Subjects 
The study involves adult human subjects.  
 
NCORP practice sites will be randomized within a 2-arm cluster randomized design utilizing NCORP practice 
sites as the unit of randomization.  A NCORP practice site will be defined as any practice location within an 
overarching NCORP designation where oncology physicians and study staff work independently (i.e., do not cross 
over into another practice site).   
 
Study subjects will include:  
• Oncology physicians at NCORP practice sites 
 
• Patients will complete surveys and will also agree to have a clinical consultation with an oncology physician 
audio-recorded (baseline visit).  Patients will have advanced cancer and various levels of functional status.  
Patients will be asked to identify a caregiver who may choose to participate in the study.  As much as possible, 
caregivers should be recruited to be part of the study when the patient is recruited.  In the rare circumstance that 
there is no willing caregiver to participate, the patient will be allowed to participate without a caregiver.   
 
• Caregivers must enroll in the study before or on the baseline visit because they will accompany the patients 
during the clinic consultation that will be audio-recorded (baseline) and complete surveys.   
 

URCC13070 Protocol 2017-04-25 
    
Page 12 of 56 
2.  STUDY OBJECTIVES  
 
This is a cluster randomized study within the URCC NCORP network evaluating whether GA summary plus GA-
driven recommendations can improve patient satisfaction with communication regarding age-related issues 
between patients, oncology physicians, and caregivers.  The study has received support from the Patient Centered 
Outcomes Research Institute (PCORI) under their “Communication and Dissemination” portfolio.  In addition, the 
National Cancer Institute (NCI) review was required which led to changes in the aims and statistical plan.  The 
NCI review led to a new primary aim (satisfaction with communication regarding age-related issues) and the 
original PCORI primary aim (discussions about age-related issues during clinic consultation) became Secondary 
Aim 1.   
 
2.1.  Primary Aim (primary aim as specified by the NCI): To determine if providing geriatric assessment (GA) 
summary plus GA-driven recommendations to patients, their caregivers and oncology physicians improves 
patient satisfaction with communication with the oncology physician regarding age-related concerns. 
 
Primary hypothesis:  Patient satisfaction with communication with the oncology physician about age-related issues 
will be significantly higher in the intervention group compared to the control group.   
 
The NCI primary outcome, patient satisfaction regarding communication about age-related issues as measured 
by a modified Health Care Climate Questionnaire (HCCQ-age), will be obtained via the Telephone Team Call, 
a phone call administered by trained personnel blinded to group assignment within 1 to 7 days of the baseline 
audio-recorded clinic consultation.   The HCCQ-age will be mailed (with a return envelope) if a telephone call 
is not feasible.  If the responses to the survey are not able to be obtained before the 4-6 week assessment, the 
HCCQ-age at 4-6 weeks will be utilized.   
 
 
2.2. Secondary Aims  
 
2.2.1. Secondary Aim 1 (primary aim as specified by PCORI):  To determine if providing GA summary plus 
GA-driven recommendations to patients, their caregivers, and oncology physicians increases discussions about 
age-related issues during clinic consultation. 
 
Hypothesis:  A higher proportion of age-related issues will be discussed and addressed in the intervention 
group.   
 
The outcome measure for this aim is the number of age-related discussions related to the different aspects of 
geriatric assessment that occur in the consultation clinic visit between the patient, oncology physician, and 
caregiver.  The clinic visit will be audio-recorded.  This outcome was accepted as the primary aim by PCORI.   
 
2.2.2.  Secondary Aim 2:  To determine whether initially providing patients, their caregivers, and oncology 
physicians with GA summary plus GA-driven recommendations prior to their treatment influences quality of 
life of older patients receiving treatment and their caregivers. 
 
2.2.3.  Secondary Aim 3:  To determine whether providing patients, their caregivers, and oncology physicians 
with GA summary plus GA-driven recommendations influences caregiver satisfaction with communication 
about age-related issues. 
 
2.3.  Exploratory Aims:     
Exploratory aims will evaluate (1) whether the number of discussions about age-related issues during the clinic 
visit correlates with patient satisfaction, (2) whether the intervention increases the proportion of age-related 
concerns that are acknowledged and addressed, and  (3)  if communication about age-related issues influences how 
patients, caregivers, and oncology physicians make decisions for cancer treatment.    An additional exploratory aim 
will examine the impact of the intervention on survival.   

URCC13070 Protocol 2017-04-25 
    
Page 13 of 56 
 
3.  STUDY DESIGN 
 
See Study Schema and Design for summary. 
 
3.1.  Choice of comparators   
Because GA is not performed by community oncology physicians and this study ultimately will allow 
patients/caregivers/oncology physicians to choose their cancer treatments, a usual care comparator arm is 
appropriate and will allow for the accurate and appropriate assessment of how the intervention can improve 
communication about age-related issues and outcomes compared to current clinical practice.  This study design is 
similar to previous studies that evaluated the impact of providing summarized HRQoL information to patients and 
oncology physicians on communication and outcomes.  Usual care was the comparator arm in these cluster 
randomized studies.57,81 
 
3.2.  Choice of study design   
The study is designed as a cluster randomized trial because a care of service model is applied to each patient by the 
oncology team.  If a cluster randomized design were not undertaken, there would be contamination in that 
oncology physicians could choose the care of service model if they were exposed to patients randomized to both 
arms.  Given rapid changes that can occur in oncology practice with new supportive care and treatment agents, it is 
important to compare outcomes in the same time frame as would be possible in a cluster randomized study design 
compared to a “pre” versus “post” intervention study design. 
 
4.  PARTICIPANT ELIGIBILITY 
 
4.1.  Entry Criteria for Oncology Physicians 
Oncology physicians must work at a NCORP practice site with no plans to leave that NCORP practice or retire 
at the time of enrollment into the study.   
 
4.2.  Entry Criteria for Patients 
 
 
 
4.2.1.  Inclusion Criteria for Patients 
 
4.2.1a.  Male or female 70 years of age or older 
 
4.2.1b.  Diagnosis of an advanced solid tumor malignancy (advanced cancer) or lymphoma.  In most 
situations, this would be a stage IV cancer.  A patient with a diagnosis of stage III cancer or lymphoma is 
eligible if cure is not possible or anticipated. Clinical staging without pathological confirmation of 
advanced disease is allowed.   
 
Must be considering or currently receiving any kind of cancer treatment (any line), including but not 
limited to hormonal treatment, chemotherapy, monoclonal antibody therapy, or targeted therapy. Patients 
who are considering therapy are eligible even if they ultimately choose not to be on therapy. Patients with 
a history of any previous cancer treatment, including radiation and/or surgery are eligible.  A patient may 
also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria 
are met.   
 
4.2.1c.  Have at least one geriatric assessment domain meet the cut-off score for impairment other than 
polypharmacy per Table 2. 
 
4.2.1d.  Have visits planned with the oncology physician for at least 3 months and be willing to come in 
for study visits. 
 

URCC13070 Protocol 2017-04-25 
    
Page 14 of 56 
4.2.1e.  Able to provide informed consent or, if the oncology physician determines the patient to not have 
decision-making capacity, a patient-designated health care proxy (per institutional policies) must  sign 
consent by the baseline visit. 
 
4.2.1f.  Subject has adequate understanding of the English language because not all GA measures have 
been validated in other languages. 
 
4.2.2.  Exclusion Criteria for Patients 
 
4.2.2a.  Have surgery planned within 3 months of consent.  Patients who have previously received surgery 
are eligible. 
 
4.2.2b.  Have already made a decision to not undergo any cancer treatment (e.g., being followed in best 
supportive care or hospice).     
 
 
4.3.  Entry Criteria for Caregivers 
A caregiver can be anyone, age 21 or over, who is able to understand spoken English and understand the study 
process and provide informed consent.  One caregiver for each patient will be eligible and must be chosen by the 
patient.  For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient’s life who 
is supportive in health care matters by providing valuable social support and/or direct assistive care.  The caregiver 
accompanies the patient to medical appointments, is able to listen and give thoughtful advice and may be a family 
member, partner, friend, or professional caregiver. 
 
4.3.1. Inclusion Criteria for Caregivers 
 
4.3.1a.  Selected by the patient when asked if there is a “family member, partner, friend or caregiver [age 
21 or older] with whom you discuss or who can be helpful in health-related matters;” patients who cannot 
identify such a person (“caregiver”) can be eligible for the study. A caregiver need not be someone who 
lives with the patient or provides direct hands-on care.  A caregiver can be any person who provides 
support (in any way) to the patient.   
 
4.3.1b.  If a health care proxy signs consent for or with a patient, and wants to participate in the caregiver 
portion of the study, this same person will always be the caregiver selected.  If a health care proxy does not 
want to enroll as a caregiver in the study or, if enrolled, chooses to stop their own participation in the 
caregiver portion of the study, but is able to assist the patient in completing the study, the patient can still 
participate.  In other words, the health care proxy can choose NOT to participate in the caregiver portion of 
the study.  This does not preclude the patient from participating in the patient portion of the study with the 
health care proxy’s assistance.   
 
4.3.2.  Exclusion Criteria for Caregivers 
 
4.3.2a.  Caregivers unable to understand the consent form due to cognitive, health, or sensory impairment 
will be excluded. 
 
 
5.  IDENTIFICATION, RECRUITMENT, AND CONSENT PROCEDURES  
 
Patients and their caregivers will be recruited from the outpatient community oncology practices affiliated with the 
URCC NCORP Research Base network.  The results of this study will be generalizable to the majority of older 
adults with cancer and their caregivers because it will include older cancer patients and their caregivers from 
diverse backgrounds and at varying health statuses. 
 
5.1.  Study Participants (Patients and Caregivers)  

URCC13070 Protocol 2017-04-25 
    
Page 15 of 56 
Study participants will be identified by their treating oncology physicians, who enroll in the study, the nurses that 
work with the enrolled oncology physicians, and the clinical research associates (CRAs).  The CRAs will work 
closely with the enrolled oncology physicians and nurses to identify patients aged 70 and over with advanced 
cancer.  The oncology physician then confirms if the patient is an eligible study candidate for all requirements 
other than GA impairment by completing the eligibility checklist with the CRA and signing it.  The oncology 
physician or CRA will introduce the study to the eligible patients and/or their designated health care 
proxies/caregivers, and will provide them with an IRB approved study brochure and consent to review.  Adequate 
time will be provided to the patient and/or the designated health care proxy to read the consent.  By this time, the 
patient should have selected a possible caregiver.  The CRA, the oncology physician, and the nurses are available 
to answer any questions the patient and/or caregiver/healthcare proxy may have about any aspect of the study prior 
to consenting and throughout the entire study period.  Patients and/or their designated health care proxies and 
caregivers may choose to sign the appropriate (patient or caregiver) informed consent documents immediately on 
the day the study information is presented to them or they may choose to take the consent forms home and discuss 
them with others; then if they decide to participate in the study, they can provide signed consent forms the next 
time they meet with the CRA or oncology physician.   
 
5.1.1.  Informed consent will be obtained from the patient, unless they lack capacity to provide consent.  If a 
patient lacks capacity, a health care proxy will be required to sign consent per institutional or local policies on 
consent for incapacitated/decisionally impaired subjects.  If the patient does not have an appointed health care 
proxy on or before the baseline visit, he/she will not be enrolled onto the study.  All consent documents will be 
signed by the patient and/or designated health care proxy and maintained in the patient record with copies 
provided to the patient and/or designated health care proxy.  
5.1.2.  The screening measures will then be performed.  Those with a diagnosis of dementia, as noted in their 
medical record or diagnosed by a physician, or who meet the cut-off score for impairment on the cognitive 
screen  (score of 11 or more on Blessed Orientation-Memory-Concentration Scale) can be included if a 
designated health care proxy selected by the subject signs the consent.  The goal of the intervention is to 
improve outcomes of older cancer patients with all underlying health conditions including cognitive issues.  
Therefore we will include these patients and will conduct the assessments with assistance of the proxy.  The 
health care proxy should agree to participate in the study as the caregiver.  If a health care proxy chooses to 
stop their own participation in the study, but is able to assist the patient in completing the study, the patient can 
still participate. 
5.1.3.  Ethical standards for human subjects will be strictly followed in accordance with local policies and/or 
institutional review board requirements on the enrollment of adult decisionally incapacitated research subjects 
and permission of authorized representatives. 
5.1.4.  Current, state, federal, and institutional regulations concerning informed consent will be followed.  
Participation in this study is voluntary.  Participants are free not to take part or to withdraw at any time, for 
whatever reason, without risking loss of present or future care they would otherwise expect to receive.  In the 
event that a patient does withdraw from the study, the information they have already provided will be kept in a 
confidential manner.  Data will be used unless permission is revoked in writing and sent to their oncology 
physician or the URCC study team.  Site oncology physicians will be directed to forward any such 
correspondence to the URCC Research Base. 
 
5.2.  Oncology Physician Recruitment  
Because oncology physicians are being recruited and enrolled from sites across the country by the URCC Research 
Base , oncology physicians will read and agree to participate either via Research Electronic Data Capture 
(REDCap) or on paper if REDCap is not a feasible option.  REDCap is a software toolset (see Section 16.3 for 
more information) for electronic collection and management of research and clinical trial data developed by 
Vanderbilt University.  Oncology physicians will be enrolled prior to enrolling (screening registration) their first 
eligible patient.  Staff from the URCC Research Base (including the PI) will be available to answer any questions 
the oncology physicians may have over the phone.  Procedures for the oncology physicians are minimal risk and 
involve:  completing surveys that will be de-identified, and identifying patients for the study. 

URCC13070 Protocol 2017-04-25 
    
Page 16 of 56 
 
Oncology physicians will provide baseline demographic information, fill out a baseline survey that evaluates 
preferences for decision-making, and help identify their own patients who may be eligible for the study. The 
baseline survey can be completed online via REDCap or on paper if REDCap is not feasible.  REDCap will 
securely store the oncology physician’s email address for surveys.  In addition to the email address, the only 
personal identifying information the oncology physicians will provide will be their name, age, ethnicity, and the 
name of the clinic where they work.  The oncology physician will be assigned an ID number, which will be used to 
link their surveys together with those of patients enrolled in the study. 
 
The oncology physician also will agree to have one visit per each patient audio-recorded (baseline).  All parties 
present for recorded office visits, including:  enrolled patients, any accompanying caregivers, family or friends, the 
oncology physician, and any other physicians or health care providers not participating in the study will be fully 
aware that the conversation is being audio-recorded and will provide verbal assent immediately before any 
recording begins, in addition to the prior written consent of enrolled subjects.  These audio-recordings will be 
labeled and stored using the patient’s initials and date.   
 
The participation of oncology physicians in the research study meets criteria for “waiver of documentation of 
consent” because the research involves no more than minimal risk to the oncology physicians and there are no 
procedures for the oncology physicians that would normally require written consent outside of the research 
context. 
 
 
6.  REGISTRATION  
 
6.1.  Prior to entering participants (i.e., oncology physicians, patients, caregivers) on this protocol, the following 
must be on file at the URCC NCORP Research Base:   
 
6.1.1.  Documentation of IRB approval in the form of an HHS Protection of Human Subjects Assurance 
Identification/IRB Certification/Declaration of Exemption (formerly Form 310), CTSU approval form or 
signed letter from the IRB. 
6.1.2.  A copy of the institution’s IRB-approved informed consent document. 
6.1.3.  Written justification for any substantive modifications made to the informed consent concerning 
information on risks or alternative procedures.   
 
These documents are submitted to: 
Cathleen_Lesniewski@urmc.rochester.edu 
OR 
 
Ms. Cathy Lesniewski 
URCC NCORP Research Base 
Saunders Research Building  
265 Crittenden Blvd 
CU 420658 
Rochester, NY  14642 
 
6.2.  Registration Requirements 
 
6.2.1. Timing of Registration: See section 11, Outline of Study-Specific Procedures. 
 
6.2.2. Screening Registration  
 
6.2.2a. Go to the URCC NCORP Research Base website at URCC-NCORP.org and enter the information 
outlined below.  
• 
Additionally if you experience difficulties you may call 585-275-5513 at the University of Rochester 
Cancer Center to verbally give the URCC registrar the information below. 

URCC13070 Protocol 2017-04-25 
    
Page 17 of 56 
• 
The following information will be requested: 
 
NCORP Affiliate Name  
 
URCC Protocol 
 
Most recent IRB approval date (either initial or annual) 
 
NCORP Practice Site 
 
Name and telephone number of person registering study participant 
 
Confirmation that consent form has been signed and by whom 
 
Confirmation of patient screening ID if participating in another URCC study 
 
Patient’s Physician Name (confirms that oncology physician has been enrolled) 
 
Patient’s identification 
 First and last NAMES 
 
6.2.3. Baseline Registration  
 
6.2.3a. Go to the URCC NCORP Research Base website at URCC-NCORP.org and enter the information 
outlined below.  
• 
if you experience difficulties you may call 585-275-5513 at the University of Rochester Cancer Center 
to verbally give the URCC registrar the information below. 
• 
The following information will be requested: 
 
NCORP Name  
 
URCC Protocol 
 
Most recent IRB approval date (either initial or annual) 
 
NCORP Practice Site 
 
Name and telephone number of person registering study participant 
 
Confirmation that all eligibility requirements have been met 
 
Confirmation that consent form has been signed and by whom 
 
Patient’s screening ID  
 
Patient’s Physician Name (confirms that oncology physician has been enrolled) 
 
Patient’s identification 
 
First and last NAMES  
 
Birth date (MM/DD/YYYY) 
 
Gender 
 
Race/Ethnicity 
 
Five-digit zip code 
 
Payment code 
 
Confirmation of patient assessment scores 
 
Date of Baseline Visit  
 
Patient’s preferred and alternate phone numbers and best time to call (for the Telephone 
Team Call 1 to 7 days after the baseline visit) and mailing address to contact the patient if 
telephone call is not feasible. 
 
Whether the patient has a caregiver enrolling in the study 
 
 
Caregivers providing consent will require the following for registration: 
 
First and last NAMES 
 
Birth date (MM/DD/YYYY) 
 
Gender 
 
Race/Ethnicity 
 
Five-digit zip code 
 
Payment code 
 
Caregiver’s preferred and alternate phone numbers and best time to call (for the Telephone 
Team Call 1 to 7 days after the baseline visit 
 
Relationship to patient 
 
Confirmation of caregiver consent 
 

URCC13070 Protocol 2017-04-25 
    
Page 18 of 56 
• 
An email confirmation of registration will be forwarded by the URCC Research Base. 
 
 
6.3.  A total of 528 patients and maximum of 528 caregivers is planned.  Each patient will be able to choose one 
caregiver to participate. 
 
6.4.  This protocol is open only to affiliates of the URCC NCORP Research Base who provide written 
documentation of IRB approval.  There will be no accrual at the URCC NCORP Research Base itself. 
 
7.  OUTCOMES 
 
The outcomes of this study were informed by preliminary data that show that older patients and caregivers rate 
communication about age-related issues as very important. 
 
7.1.  NCI-specified Primary Outcome  
The Health Care Climate Questionnaire (HCCQ) 82-85 measures patient-centered autonomy-supportive physician 
behaviors and satisfaction with communication such as whether the patient and caregiver feel that the physician 
understands his/her perspective, provides choices and options, and encourages participation in decisions.  The 
measure has been studied and validated in older patients.  Similar to other studies which adapt satisfaction scales to 
capture specific clinical criteria (e.g., satisfaction with the physician regarding communication about 
chemotherapy),86 the HCCQ has been modified for this study (HCCQ-age) to specifically address patient 
satisfaction with oncology physician behaviors and communication regarding age-related issues and concerns in 
order to specifically address satisfaction with the intervention (geriatric assessment summary and 
recommendations) rather than satisfaction with other aspects of cancer care (e.g., communication about cancer 
treatment).  As is done with satisfaction with care surveys in other research and in clinical settings, the HCCQ 
(both modified and original) will be administered within 1 to 7 days after the baseline audio-recorded clinic visit.87-
90  These measures will be obtained via a phone call administered by trained personnel (or mailed if a telephone 
call within 2 weeks of the baseline visit is not feasible).  If this is not completed, the 4-6 week visit HCCQ data 
will be used in its place. Our University of Chicago collaborators (Dale and Gorawara-Bhatt) have experience with 
the conduct of such assessments over the phone and this minimizes perceived or real influence from the oncology 
physician or Research Base.  The University of Chicago collaborators and research staff, who are subcontracted 
through PCORI, will be blinded to group assignment as the Telephone Team.  Press-Ganey measures of 
satisfaction of overall care will be collected at week 4 and in follow up visits.  The HCCQ will also be completed 
as part of the patient and caregiver packets in follow up time points for comparison.  
 
Dr. Epstein’s research team has extensive experience76,85 with the use of the HCCQ and has captured this measure 
in 81 patients similar to those who will be recruited for the proposed study (older patients with advanced cancer).  
Patients were recruited to a NCI-funded study that is evaluating a coaching intervention to improve physician 
communication behaviors.91  Because the study utilizes a cluster randomized design, an intracluster correlation 
coefficient (ICC) was estimated from existing data to assist with sample size calculations for the current proposal.   
HCCQ has 5 questions measured on a Likert scale of 1-5, which are added to create a score between 5-25.  Ceiling 
effects are common with HCCQ and with patient satisfaction scales in general, although the modified version 
likely has less of a ceiling effect due to its focus on a specific clinical scenario.  Despite the ceiling effects, policy 
makers have utilized patient satisfaction as a key measure for reimbursement in clinical practice, with a focus on 
obtaining “perfect” scores.   
 
For example, the Hospital Value-Based Purchasing (VBP) Program92 is a Centers for Medicare & Medicaid 
Services (CMS) initiative established by the Affordable Care Act of 2010 to reward acute-care hospitals with 
incentive payments for the quality of care they provide to people with Medicare.  Incentive payments are funded 
by a withhold of 1-2% of each hospital’s base operating DRG payments for each patient discharge over a year, 
placing hospitals “at risk” for this amount based upon performance on quality measures.  It is estimated that 
roughly half of participating hospitals will receive a net decrease in payments, while the remainder will receive a 
net increase in payments resulting from superior performance.  The HCAHPS (Hospital Consumer Assessment of 
Healthcare Providers and Systems) survey, which is the first national, standardized, publicly reported survey of 
patients’ perspectives of hospital care, represents the performance measurement for the VBP Patient Experience of 

URCC13070 Protocol 2017-04-25 
    
Page 19 of 56 
Care Domain.  The HCAHPS survey is quite similar to the HCCQ in the questions that capture satisfaction with 
perceived understanding of patient’s values and goals by the physician and communication about health care 
choices.  In terms of reimbursement, CMS uses performance on nine measures from HCAHPS and each hospital’s 
“top-box” raw score—the percentage of a hospital’s patients who chose the most positive, or “top-box”—is 
utilized to calculate their Achievement Points and Improvement Points.  In this manner, the HCAHPS score is used 
as a binary variable, with hospital performance and, therefore, payment depending upon the survey respondent’s 
choice of either the highest rating or any other rating. 
 
As a result, an intervention that can lead to the slightest improvement in patient satisfaction scores has important 
policy implications.  This is evident by studies that demonstrate the effectiveness of models of care interventions 
with small differences in patient satisfaction scores.87,93-95 
 
7.2.  Secondary Outcomes  
Secondary aim 1 will evaluate whether the GA intervention increases discussions regarding age-related issues 
between the patients, caregivers and oncologists.   This measure of direct communication was accepted by PCORI 
as the primary aim for the study.  For this aim, the first medical consultation after GA administration will be audio-
recorded.  This data will be sent to the URCC Research Base and there it will be transcribed and content analyzed 
with the aid of a checklist to determine whether the topics included in the GA were discussed and to record the 
total length of consultation.  Audio-recordings will be transcribed for quantitative analysis of the communication 
processes, including number of questions asked and topics discussed.57,76,96-98  Methodology has been established in 
prior work by Dr. Epstein’s group.  For each transcript, coding will be performed directly by 2 trained raters who 
will be blinded to group assignment. A summary of coding procedures including assessment of inter-rater 
reliability and resolution procedures for disagreement is included in Appendix X-8.     
 
The coding schema includes definitions for each code and the specific steps the coders performed during the 
coding process. The coding procedures involve an initial reading of the transcript to identify specific geriatric 
concerns and the initiator of the concerns, followed by a second reading, in which response quality and 
interventions implemented due to concerns are identified.  
 
Five coders were involved in the coding process, with 20 percent of the transcripts coded by all five coders to 
establish and maintain inter-rater reliability; the remaining transcripts were all dually coded. For each transcript, 
whether dually coded or coded by the entire coding team, a consensus was agreed upon and a final coding table 
created for that transcript. These final consensus tables are what will be utilized in the analysis of the data.  
 
Due to the coding schema involving a conditional coding structure, inter rater reliability involved percent 
agreement in 3 coding areas: number of geriatric concerns, the category of geriatric domain discussed, and the 
physician’s response quality. A GA communication composite score will be created by adding all GA-related 
topics that were discussed for each visit. For number of geriatric concerns, the percent agreement was calculated 
using the difference in numbers between each coder and the consensus. An average of all coder agreement was 
calculated for the category of geriatric domain and physician response quality. If inter-rater agreement percentages 
fell below 70%, the coding team would meet for additional training. The principal investigator remained involved 
in the coding process and provided guidance or adjudication when necessary.  
 
 

URCC13070 Protocol 2017-04-25 
    
Page 20 of 56 
Another secondary outcome measure will be patient-reported HRQoL as measured by the FACT and caregiver 
HRQoL (burden) as measured by the Caregiver Reactions Assessment (CRA).  We hypothesize that the mean 
HRQoL for patients and caregivers at sites randomized to the intervention arm will be higher than for those in the 
usual care arm at 4-6 weeks following the intervention and that this increase will be both statistically significant 
and clinically meaningful.99,100 We will include GA impairment (at baseline and follow up) to evaluate if these 
influence patient-reported and caregiver-reported HRQoL differently in the intervention versus the control group.  
Other secondary outcomes will include whether the intervention impacts how the oncology physician 
acknowledges and addresses age-related concerns, caregiver burden (as measured by the Caregiver Reaction 
Survey) and caregiver satisfaction with communication (as measured by the modified HCCQ) at 4-6 weeks.  We 
will follow participants for survival for 12 months after enrollment.  We will obtain the date, location of death, and 
cause of death. If a site becomes aware that a study participant is deceased, they should complete the form which is 
available on the URCC NCORP website. Otherwise sites will be contacted approximately 1 year after each 
participant was enrolled to assess survival and asked to complete this form. 
 
7.3.  Data Sources 
 
7.3.1.  Audio-recordings.  As part of baseline procedures, a clinic visit for both arms will be audio-recorded 
for the analysis of content.  For our secondary and exploratory aims, outcome measures are derived from 
audio-recordings of oncology physician-patient visits (often with a caregiver present).  All enrolled patients 
(Arm 1 and Arm 2 groups) will have one office visit with their participating oncology physician audio-
recorded (baseline visit).  All parties present for recorded office visits, including: enrolled patients, any 
accompanying caregivers, family or friends, the oncology physician, and any other physicians or health care 
providers not participating in the study will be fully aware that the conversation is being audio-recorded and 
will provide verbal assent immediately before any recording begins, in addition to the prior written consent of 
enrolled subjects (oncology physicians, patients, and caregivers).  Patients, caregivers and oncology physicians 
may receive copies of these recordings at their request. 
 
7.3.2.  Patient Surveys.  Patients will complete surveys prior to the start of treatment at screening and 
baseline, and the Telephone Team Call within 1 to 7 days from baseline, and at 4-6 weeks, 3 months, and 6 
months.  We are sensitive to respondent burden and have minimized the number of items to be completed in a 
single sitting.  All surveys have been utilized in our pilot work with older patients with cancer and other age-
related health conditions.  In a recent study, 98% of patients with non-small cell lung cancer with a median 
survival of 9 months completed a baseline battery similar in length, and 70% and 64% of those who were still 
alive were able to complete assessments at 3 and 6 months, respectively.101,102  As is often true for patients with 
advanced disease, missing data were not random; sicker patients tended not to complete surveys.  We have 
included approaches to missing data in the statistical section of the protocol. 
 
7.3.3.  Oncology Physician Surveys.  Oncology physicians will complete a baseline survey prior to or when 
their first patient consents to the study and a brief follow-up survey at the end of the study.  After the audio-
recorded baseline clinic visit, oncology physicians will be asked about potentially important covariates or 
moderators, including disease and treatment characteristics.   
 
7.3.4.  Caregiver Surveys.  Caregivers will complete surveys at the same time points as patients.  However, 
caregivers will not receive the Telephone Team Call.  We will also ask caregivers to assess satisfaction with 
communication and care, satisfaction with decisions, and caregiver burden (both personal and economic).103 
 
7.3.5.  Chart Abstraction and Claims.  If there is missing information or conflicting medical information 
from the surveys, we will obtain medical records in order to verify information about disease location, 
pathology, stage, metastases, and survival status from charts. We will request information from the CRA on 
recommendations made and implemented.  In order to assess health care utilization (e.g., adverse events such 
as hospitalizations) for future work on examining cost-effectiveness of the intervention, permission to obtain 
Medicare claims in the future will be asked on the consent form.   Claims will not be obtained for any 
individual patient until the patient has completed study procedures.  All consent and research procedures for 

URCC13070 Protocol 2017-04-25 
    
Page 21 of 56 
obtaining Medicare claims will be followed: http://www.cms.gov/Research-Statistics-Data-and-
Systems/Computer-Data-and-Systems/Privacy/Researchers.html 
 
Permission to obtain claims is voluntary.  Patients will be able to decline this procedure at the time of consent.  
Declining consent for obtaining claims from Medicare for future research to examine cost-effectiveness, 
quality of care, and health care utilization does not preclude patients from participating in this study. 
 
8.  MEASURES TO BE COLLECTED 
 
An overview of measures is provided here.  A detailed description of each measure including a summary table 
with collection time points is provided in Appendix X-1:  Measures. 
 
Patient and Caregiver Measures: 
  Demographics 
  Medical Characteristics and Treatment 
  Com-meds/Polypharmacy/Baseline Labs 
  Geriatric Assessment 
      - Assessments by CRA 
      - GA Patient Packet 
   Communication & Treatment Preferences  
   Satisfaction and QoL  
  Caregiver Health and Economic Burden  
 
We have piloted all measures.  In total, geriatric assessment measures that are filled out by the patient require 
approximately 20 minutes of time.  The additional measures require an additional 30 minutes of time.  We have 
incorporated flexibility with timing in order to reduce patient burden.  The follow-up surveys require about 30 
minutes of time in total.  The caregiver surveys at each time point require approximately 30 minutes of time.    
 
Patients may complete the first geriatric assessment in clinic at time of consent or at in clinic before next visit with 
the oncology physician.  They may choose to complete measures at home in between visits.  The geriatric 
oncology clinic at the University of Rochester routinely captures these measures as part of clinical care. 
 
The assessments performed by the CRA and associated surveys take about 30 minutes of time in total (including 
physical performance and cognitive tests).  Any person at the practice site can be trained by Research Base staff to 
do the GA.  The GA does not need to be performed by the oncology physician. 
 
The oncology physician assessments will be done either on paper or through REDCap, whichever the oncology 
physician prefers.  The baseline and end of study assessments take no longer than 10 minutes and after the initial 
patient visit, the decision-making form (to assess factors that influenced decisions) takes only a few minutes to 
complete.   
 
8.1.  Components of Geriatric Assessment (Patient) 
Assessment tools comprising the comprehensive GA are listed in Table 2.  The various assessment tools were 
selected based upon extensive data in the geriatric literature demonstrating predictive value as well as feasibility 
data in multiple studies of elderly patients with cancer.  Other than the cognitive and physical performance 
measures, the assessments are self-administered.  Patients who cannot complete the assessment on their own will 
receive assistance from study personnel or from a caregiver.  The GA is performed before baseline registration. 
Follow-up GA measures are collected at 4-6 weeks, 3 months, and 6 months.   
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 22 of 56 
Table 2:  Components of the Comprehensive Geriatric Assessment 
 
***Captured before baseline registration 
Abbreviations: ADL (Activities of Daily Living); Blessed OMC (Blessed-Orientation Memory Concentration Test); GAD 
(Generalized Anxiety Disorder 7-Item Scale); GDS (Geriatric Depression Scale); IADL (Instrumental Activities of Daily 
Living); QoL (Quality of Life). 
 
 
8.2.  Other Clinical Measures (Patient and Caregiver) 
8.2.1.  Sociodemographics*** (patient and caregiver):  Age, race and ethnicity, gender, highest level of 
education achieved, employment status, marital status, and presence of a living companion will be captured.  
We will also assess financial concerns and understanding of disease. 
 
8.2.2.  Tumor and Treatment Characteristics (patient):  The tumor stage, previous surgery or radiation, 
previous cancer treatment, current cancer treatment plan  (if any) will be captured by the CRA. 
 
8.2.3.  QOL, Symptoms, and Distress (patient and caregiver):  Quality of life measures will include 
assessments of distress and symptoms.  Quality of life and symptoms will be measured using validated 
assessments.  Caregivers will complete validated measures to assess impact of caregiving on their quality of 
life.  Caregiver economic burden will be assessed including time required to give care.   
8.3.  Processes of Communication and Experience of Care Assessments (Patient/Caregivers and Oncology 
Physician) 
8.3.1.  Patient/Caregiver Assessments:  We will collect measures to assess patient and caregiver satisfaction 
with communication, experience of care, and decision-making preferences.  The measures chosen for this 
DOMAIN 
TOOL  
SCORE SIGNIFYING IMPAIRMENT 
Physical function  
 Activities of Daily Living 
 Instrumental ADLs 
 Fall History 
 OARS Physical Health 
 Any ADL deficit 
 Any IADL deficit   
 Any history of falls  
 A lot of difficulty with any task 
Objective physical 
performance  
 Short Physical Performance Battery 
 Timed “Up and Go”*** 
  ≤ 9 points 
 
 >13.5 seconds  
Comorbidity 
 OARS Comorbidity*** 
 Patient answered “yes” to ≥3 chronic 
illnesses 
 One illness interferes “a great deal” with 
QoL 
Nutrition 
 Body Mass Index 
 Mini Nutritional Status*** 
 Weight loss*** 
 <21 kg/m2 
 ≤ 11 points 
 >10% from baseline weight 
Social support 
 OARS Medical Social Support*** 
 Patient answers one of the social support 
questions indicating less than adequate 
support for care 
Polypharmacy 
 Polypharmacy 
 
 
 Lab*** 
 ≥5 regularly scheduled prescription 
medications OR 
 Any high-risk medication OR 
 Creatinine clearance <60 ml/min 
Psychological 
 GAD-7 *** 
 Geriatric Depression Scale 
 > 10 points 
 ≥5 points 
Cognition 
 Blessed OMC*** 
 Mini-Cog 
 
 >10 
 0 words recalled OR 1-2 words recalled + 
abnormal clock drawing test 

URCC13070 Protocol 2017-04-25 
    
Page 23 of 56 
study are validated tools designed to measure patients’ and caregivers’ confidence in their ability to 
communicate their concerns, obtain and understand information, ask questions, clarify uncertainties, and make 
sure that their oncology physician understands them.  We will measure understanding of prognosis, acceptance 
of terminal illness, and perceived uncertainty in choosing options.  At follow up visits, patient and caregiver 
satisfaction with the decision and experience of care will be assessed with validated tools.  
 
8.3.2.  Oncology Physician Assessments:  We will collect information on sociodemographics and decision-
making preferences.  Oncology physicians will be presented with a clinical scenario of elderly cancer patients 
with a variety of geriatric-related impairments (i.e., physical frailty, cognitive impairment).  A series of 
questions will follow each vignette inquiring about the likelihood of the oncology physician to offer 
chemotherapy and cancer treatments in the scenario.  After the study is over, physicians will be asked to 
complete a brief follow-up survey. After the audio-recorded clinical encounter, oncology physicians will 
complete a short follow-up survey (<10 questions) requesting information on the plan for the patient and 
factors that influenced how the decision was made.   
 
8.3.3.  Audio-recordings of oncology physician-patient visit:  A CRA will audio-record the patient-oncology 
physician consultation (baseline study visit).  For our Secondary and Exploratory aims, we will assess the 
number of age-related concerns brought up by patients and caregivers.  Coders will undergo extensive training 
and supervision by developers of the scales, will not be involved in any other aspects of the study, and will be 
blind to study hypotheses and assignments for intervention vs. control. Please refer to Appendix X-8 for full 
coding procedures. 
 
 
9.  NCORP PRACTICE SITE RANDOMIZATION  
 
A practice site is defined as any practice location within an overarching NCORP designation where oncology 
physicians and study staff work independently, i.e., do not cross over into another site.  Practice sites will be 
randomized to one of the two study arms by means of a computer–generated randomization table.  The 
randomization process will be determined using R software provided by Dr. Charles Heckler, the lead 
biostatistician of the URCC NCORP Research Base. 
 
Sites are randomized on a continual basis due to a variety of factors (i.e., a new NCORP Community Affiliate has 
been added to the URCC NCORP Research Base network, a new oncology practice site has been added to an 
existing NCORP Community Affiliate, or an oncology practice site that is currently affiliated with an NCORP 
Community Affiliate has expressed interest in participating in the COACH study). Past accrual to URCC studies 
(or NCORP Cancer Control studies if URCC accrual information is not available for new Affiliates and sites) is 
used to stratify each practice site as a large accruing (20 or more accruals/year) site or a small accruing (less than 
20 accruals/year) practice site in order to assure balance in the randomization.  The general assumption will be that 
any new site will be considered “small”, unless it is determined based on past accruals that they are large. For new 
oncology practice sites that meet the definition for being independent (i.e., physicians and staff that do not cross 
over into another site), the next unassigned randomization allocation, from the randomization table will be used to 
assign their study arm. The randomization table takes into account size of the practice site.   If a new oncology 
practice site is added at a later time during the study with physicians/staff that also see patients (cross over) at both 
or multiple practice sites, the new practice site will be assigned to the same study arm as the already randomized 
practice site where the physician/staff also sees patients.  
 
Once sites have IRB approval on file with the Research Base and at least one member of research staff is trained 
on all study procedures, they are notified of their randomization allocation by an email from the study PI, Dr. 
Mohile. Practice sites names and randomization assignments are saved in the database, this is used to link to which 
arm each study patient belongs to during patient registration.  
 
The original sample size calculation (Section 15) was based on the randomization of the 16 NCORP oncology 
practice sites.  During study startup, as the structure of the new NCORP affiliates unfolded, more practice sites 
than was anticipated were interested in participating.  The original protocol included the ability for more sites to 
participate, since the increase in the number of the clusters also increases the statistical power of the study.    

URCC13070 Protocol 2017-04-25 
    
Page 24 of 56 
10. INTERVENTION OVERVIEW FOR PHYSICIANS 
 
Practice sites will be notified if they are in the intervention arm by URCC Research Base staff. Prior to the 
intervention, oncology physicians will receive training on how to best utilize GA information in clinical practice 
for older adults with cancer.   The training session provides a brief overview of the intervention information and 
can be completed through a web conference, telephone call, or as a paper “sign-off” documenting review of the 
materials.  The training materials were developed with resources from Drs. Mohile’s and Hurria’s geriatric 
oncology lectures.   
 
The CRAs and/or research nurses at sites randomized to the intervention arm will be trained to utilize the 
mycarg.org website to derive a summary of GA scores and a list of targeted GA-driven recommendations.   
 
This information will be printed by the site CRAs for the oncology physician who will “sign off” that he/she has 
received and reviewed the information.   Study or clinical staff can assist the physician in checking which 
recommendations were considered and facilitating implementation of GA-driven recommendations.  Two copies of 
the summary and checklists should be made: one should be provided to the patient/caregiver and one should be 
retained in the study chart. Patients and caregivers should be provided with a copy of the GA summary and GA-
driven recommendation forms prior to the audio-recorded visit.  The original forms should be submitted to the 
URCC Research Base.  
 
 

URCC13070 Protocol 2017-04-25 
    
Page 25 of 56 
11.  OUTLINE OF STUDY-SPECIFIC PROCEDURES  
 
 
 
 
Baseline: Visit 1 – Intervention 
• CRA enters GA Score on MYCARG.ORG  
• Print and provide GA summary and recommendations 
forms to oncology physician, patient and caregiver.  
• Information on cognitive impairment or depression is 
included in summary. 
Baseline: Visit 1 – Usual Care 
 
• Inform oncology physician if depression (GDS) or 
cognition (BOMC) assessments score ≥ 11.  
 
Telephone Team Call to Patient within 1 to 7 days of Baseline Visit  
Health Care Climate Questionnaires will be obtained via a phone call administered by trained personnel blinded to 
group assignment within 1 to 7 days of the baseline audio-recorded clinic consultation. 
All Follow-up Visits: Visit 2*, Visit 3, Visit 4    
 (Visits are 4 to 6 Weeks, 3 months, and 6 months from Baseline) 
Before Visit:  Confirm patient & caregiver will bring completed packets to study visit. 
During Visit: Administer cognitive and physical performance measures and complete CRA study forms.   
Inform oncology physician if depression (GDS) assessment score ≥ 11.   
*Intervention Arm ONLY: CRA complete GA-driven recommendation follow-up forms at visit 2 
After Visit:    Submit all forms to URCC Research Base within 7 days. 
Score GA & Complete Baseline Registration  
• When patient and CRA screening forms complete, score each GA measure as per training procedures (at screening or
beginning of baseline visit prior to study visit with oncology physician).   
• Complete baseline registration for patient & caregiver if patient has 1 or more domains  that meet cut-off score for 
impairment (other than polypharmacy).  
Screening:  Visit 0 
• Consent patient & caregiver; complete screening registration.  
• If time permits, administer GA measures (cognitive, physical performance, and nutrition) to patient. 
• Subjects (patient and caregiver) complete screening packet during visit or take the screening packet & baseline 
packet home with them to complete prior to the baseline visit. 
• CRA completes CRA screening study forms. 
• Confirm subjects will bring completed packets to next visit or schedule additional time if needed to complete at 
visit.
Oncology Physician Enrollment – Baseline survey on REDCAP 
Subject Identification Process  
Intervention Site (Arm 1) 
Usual Care Site (Arm 2) 
• Study visit with oncology physician occurs  - audio record this visit 
• Oncology physician completes forms about patient  
• Submit all materials to URCC within 7 days. 

URCC13070 Protocol 2017-04-25 
    
Page 26 of 56 
11.1.  Procedures Prior to Screening Visit  
 
11.1.1.  Oncology Physician Enrollment and Participation 
 
11.1.1a.  If an oncology physician is interested in the study and meets the inclusion/exclusion criteria, 
he/she will  agree to participate on paper or through REDCap (sent by the URCC Research Base). 
 
11.1.1b.  The oncology physician will complete a baseline survey on demographics and treatment 
preferences either on paper or through REDCap. 
 
11.1.1c  Ideally oncology physicians are enrolled as soon as possible.  However, an oncology physician 
can be enrolled after his/her patient is identified for the study or prior to screening registration for the first 
identified patient.  
 
11.1.2.  Subject Identification Process  
 
11.1.2a.  Patients:  Once a site is IRB approved, the site study staff can start screening for patients  
according to the inclusion/exclusion criteria for patients (Section 4.2).  Only patients from enrolled 
physicians can be registered. 
 
11.1.2b.  Screening Log:  A screening log will be kept at each participating site, where both patients and 
caregivers approached for the study will be entered by site study staff. 
 
11.2.  Screening:  VISIT 0  
 
11.2.1.  Patient & Caregiver Recruitment & Consent Process 
 
11.2.1a.  Patients 
• 
The site study staff will notify the patient’s oncology physician when a patient is identified as a 
possible candidate for the study.  Site study staff should screen for patients who may fit eligibility 
criteria for all requirements other than GA impairment. It is anticipated that some of the patients who 
are eligible will be new patients for the oncology physician. 
• 
The oncology physician and/or CRA should mention the study to the patient and give out recruitment 
materials.  
• 
If the patient is interested, the oncology physician and/or site study staff will explain the study and 
once all aspects of the study have been discussed to the patient’s satisfaction, the voluntary written 
informed consent procedures will be completed with the patient if they choose to enroll in the study.  
• 
Patients should choose a caregiver to participate.  As much as possible, caregivers should be recruited 
to be part of the study when the patient is recruited.  In the rare circumstance that there is no willing 
caregiver to participate, the patient will be allowed to participate without a caregiver.  URCC 
Research Base staff should be notified prior to patient registration if there is no designated caregiver.   
• 
The site study staff can schedule a separate visit with the patient and/or caregiver to go over the 
consent and initiate study procedures if more time is needed.   
 
11.2.1b.  Caregivers 
• 
If a caregiver, chosen by the patient, is interested in the study and meets the inclusion/exclusion 
criteria, the site study staff will confirm eligibility (as per section 4.3) and complete the informed 
consent procedures with the caregiver. Caregivers must enroll in the study before or on the baseline 
visit. 
 
11.2.2.  Patient & Caregiver Assessment Process 
 
11.2.2a.  Once a patient has consented, screening and baseline assessments/procedures can occur.  Site 

URCC13070 Protocol 2017-04-25 
    
Page 27 of 56 
study staff can schedule a separate visit with the patient and caregiver to complete study procedures if 
more time is needed.  
 
11.2.2b.  The procedures for screening will consist of the steps below: 
• 
Confirm that the patient’s oncology physician has been enrolled onto the study and if not, follow 
procedures for enrolling oncology physicians.   
• 
Patients meeting eligibility criteria are initially registered with a screening registration after signing 
consent. 
• 
Administer Cognitive, Physical, and Nutritional Assessments to the patient. 
 
These assessments can be administered right after consent, at a separate visit scheduled by site 
study staff, or just prior to the next oncology physician visit.  Allow 45 minutes to perform 
assessments if done just prior to an oncology physician visit.   
 
Anyone at the practice site can administer cognitive and physical assessments to the patient as 
long as they have participated in the required GA training administered by the URCC 
Research Base.  CRAs, clinical nurses, and technicians are all eligible to participate in training 
and can complete GA study procedures.   
• 
Patient will complete all screening surveys. 
 
Ideally the patient will complete either at the time of consent or the screening and baseline 
packets can be taken home and completed before the next visit with the oncology physician.  If 
the patient needs assistance from site study staff to complete surveys, allow adequate time.  
Approximately 60 minutes is recommended.  
• 
Abstract required medical information from chart. 
 
11.2.2c. The GA must be completed prior to the study visit with the oncology physician.  The study 
visit with the oncology physician will be audio-recorded with the oncology physician and patient.  
The caregiver should be encouraged to attend this study visit, but the study visit can occur without 
the caregiver present if the caregiver is not available. 
 
11.2.2d.  The procedures for the caregiver assessments will consist of the steps below: 
Caregivers will complete all baseline surveys. Caregivers will complete either at the time of consent or the 
packet can be taken home and should be completed before the next visit with the oncology physician.  
 
11.3.  Baseline:  VISIT 1 
 
11.3.1.  Patient & Caregiver Assessment Process 
 
11.3.1a.  BEFORE BASELINE VISIT: 
 Site study staff will telephone the participant to:  
• 
Confirm scheduled visit with the oncology physician. 
• 
Confirm that the patient and caregiver completed the screening surveys before the oncology 
physician visit and remind them to bring the surveys in with them. 
 
Schedule the patient to come in to meet with site study staff at least 45 minutes prior to the 
oncology physician visit in order to complete study procedures.  Allow for more time if patient 
and caregiver communicate(s) that surveys have not been completed. Only patients who 
complete GA procedures can be registered for the study.   
 
11.3.1b.  AT THE BASELINE VISIT: 
• 
If the patient’s screening surveys have not been completed prior to the patient coming in, complete 
them now. 
• 
If the caregiver’s surveys have not been completed prior to the caregiver coming in, complete them 
now. 
• 
If not complete staff should administer cognitive, physical performance, and nutrition assessment. 
• 
If not complete, staff should complete CRA study forms. 

URCC13070 Protocol 2017-04-25 
    
Page 28 of 56 
• 
If not complete, complete baseline surveys. The baseline surveys do not need to be completed prior 
to registration, but should be completed on the day of the baseline visit. For example, patients can 
complete baseline surveys while receiving cancer treatment that same day. 
• 
Score each GA measure as taught in the training procedures.  If assistance is needed for scoring, 
contact the URCC NCORP Research Base.  
• 
Patients who have at least one abnormal GA score other than polypharmacy can move forward with 
the study. 
• 
After the GA and the above steps are complete, the baseline registration procedures can be 
completed for the patient and caregiver (refer to section 6, Registration). 
 
Registration must occur prior to baseline study visit with the oncology physician. 
• 
Prior to the study visit with the oncology physician, if depression (GDS) or cognition (BOMC) 
assessments score ≥ 11, inform patient’s oncology physician as follows: 
 
Usual Care arm -- inform oncology physician with template as per training. 
 
Intervention arm -- information on cognitive impairment or depression is included in summary 
(see section 11.3, Intervention Procedures). 
 
11.3.2.  Intervention Procedures (Only for sites randomized to the intervention arm) 
 
11.3.2. a. AT THE BASELINE VISIT: 
• 
After the patients have been registered for the study, enter the GA scores into the mycarg.org 
website or if no internet is available, contact the URCC NCORP Research Base to assist. 
• 
After entering the GA scores, print the built pdf packet specific to that patient. 
• 
Present GA summary form and recommendation forms to oncology physician to review just prior to 
baseline patient-oncology physician visit.  Study staff can assist the oncology physician in the 
completion of the forms.  Study and clinical staff can assist in implementing GA-driven 
recommendations after physician approves them. 
 
Information on cognitive impairment or depression is included in the summary. 
 
The oncology physician MUST review and sign the summary form and recommendations 
forms. 
 
GA recommendations that are planned by the oncology physician for the patient should be 
check-marked by the end of the visit. 
• 
Three copies of the GA summary and GA recommendations forms should be made: one should be 
provided to the patient, one should be provided to the caregiver (if requested), and one should be 
retained in the study chart.   
• 
The original forms should be sent into the URCC Research Base.   
 
11.3.3.  Oncology Physician Assessment for Patients:  After the audio-recorded baseline visit, oncology 
physicians will complete a brief survey (on paper) to capture factors that influenced the decision-making 
process for the patient’s plan.   
 
11.3.4.  Submitting Materials to the URCC Research Base:  
 
11.3.4a.  After the audio-recorded baseline visit, site study staff should ensure the forms below are 
completed and submit them to the URCC Research Base: 
• 
All oncology physician, patient and caregiver assessments from above 
• 
All CRA Study Forms 
• 
Audio-recordings  (submitted and stored as per training)  with Audio-recording Data Form 
• 
Intervention summary and recommendation forms (if applicable). 
 
11.3.5.  Audio-recordings (for both intervention and usual care)  
 
11.3.5a.  The first visit with the oncology physician following the completion of GA measures will be 
audio-recorded for analysis of content and process of communication.  

URCC13070 Protocol 2017-04-25 
    
Page 29 of 56 
11.3.5b.  Site study staff need to ensure that two audio-recorders are on and working during the visit, but 
do not need to be present in the room during the visit.  
11.3.5c.  Site study staff will submit audio-recordings as per training and complete the audio-recording 
data form. 
 
11.4.  Follow-up Visits 
 
11.4.1.  Visits will occur 4-6 weeks after the baseline audio-recorded visit,  3 months after the baseline 
audio-recorded visit (10-14 weeks), and 6 months after the baseline audio-recorded visit (20-24 weeks). 
 
11.4.1a.  BEFORE EACH FOLLOW-UP VISIT: 
Study staff will telephone the participant to:  
• 
Confirm scheduled visit with the oncology team.  The visit does not need to be scheduled with the 
oncology physician. 
• 
Confirm that the patient and caregiver completed the surveys. 
 
Surveys must be completed during the appropriate window for each time point.  Site study 
staff can either mail the follow-up surveys to the subjects OR at the end of one visit, they can 
provide the next round of surveys to the subjects to take home with them for the next follow-
up visit. 
 
Ideally subjects will complete the survey packet at home and bring to site study staff on the 
day of a routinely scheduled visit for the oncology physician visit or designee (e.g., nurse 
practitioner) or cancer treatment.   
 
If the patient needs assistance from site study staff to complete surveys on-site, allow adequate 
time (45-60 minutes).  
 
If patients and  caregivers cannot complete packet at home:  
 
Patient and caregiver can come in prior to office visit to complete surveys. 
 
Patient and caregiver can complete surveys during cancer treatment visits (e.g., 
chemotherapy infusion). 
 
If needed, the patient and caregiver can meet with the site study staff at an additional time 
to complete the follow-up surveys. The subjects do not need to meet with the oncology 
physician to complete the surveys.  
 
11.4.1b.  AT EACH SCHEDULED FOLLOW-UP VISIT:  
• 
Staff will administer the following assessments to the patient: 
 
Cognitive and Physical Performance. 
 
If depression (GDS) assessment score ≥ 11, both usual care arm and intervention arm 
inform patient’s oncology physician with template as per training. 
• 
CRA:  Complete all CRA follow-up study forms. CRAs at practice sites randomized to the 
intervention arm will complete the GA-Recommendation Follow-up forms by comparing them to 
the GA-Recommendation Baseline forms, clinic note, and referring to the oncology physician (if 
needed). 
• 
Patient:  Complete all surveys in the follow-up packet. 
• 
Caregiver:  Complete all surveys in the follow-up packet.   
• 
Site study staff will submit the following to the URCC Research Base: 
 
All oncology physician, patient and caregiver surveys from above. 
 
All CRA study forms. 
 
11.4.1c. A subset of the chart notes will be requested if there are discrepancies or missing information in 
key data. 
 
11.5.  Telephone Team Call (1 to 7 days from Baseline) 
The Telephone Team will consist of University of Chicago and University of Rochester research staff and will 
be blinded to group assignment. The Telephone Team will make a phone call to the patient subject within 1 to 

URCC13070 Protocol 2017-04-25 
    
Page 30 of 56 
7 days, or up to 2 weeks, of the baseline clinic consultation to assess patient satisfaction with communication 
about age-related issues and concerns. The phone call will be recorded.  
 
11.5.1.  BEFORE THE PHONE CALL: 
 
11.5.1a.  Site Study staff will provide the patient subject’s preferred and alternate phone numbers, best 
time to call, and mailing address as part of the registration process for the patient. Caregiver phone number 
will be obtained as a back-up.    
 
11.5.1b.  To ensure that the Telephone Team remains blinded to the patient’s group assignment, the 
Telephone Team will obtain the contact information (phone number and mailing address) from the URCC 
Research Base. 
 
11.5.1c.  The study materials will be mailed (with a return envelope provided) to the patient by the 
Telephone Team  if a telephone call is not feasible (e.g., due to sensory or disability impairments).  
 
11.5.2.  DURING THE PHONE CALL:  
 
11.5.2a. The Telephone Team will administer the Health Care Climate Questionnaires to the patient. 
Telephone Team will submit the Health Care Climate Questionnaires to the URCC Research Base and 
keep a copy labeled with patient identification number on site. 
 
12.  REIMBURSEMENT  
 
In order to improve study retention and compliance, we will compensate patients and caregivers for their 
participation (i.e., time and travel). Patient and caregiver subjects will each receive $15.00 for every time point 
assessment completed. Both patients and caregivers can receive up to $60.00 each if all four time point 
assessments are completed.  
 
13. ADVERSE EVENT REPORTING  
 
13.1.  Risks from participating in this research are psychological distress from completing the questionnaires and 
the cognitive testing.   
 
13.2.  ADVERSE EVENTS RELATED TO STUDY PROCEDURES AND NOT TO ROUTINE ONCOLOGY 
TREATMENT AND CARE will be reported using the URCC Adverse Event form. This form can be found on the 
URCC NCORP Research Base website. 
 
13.3.  Adverse events will be reported in accordance with the following guidelines: 
 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
 
Unexpected 
and Expected 
Unexpected 
Expected 
Unexpected 
Expected 
Unexpected 
Expected 
Unexpected 
Expected 
With 
Hospital-
ization 
 
Without 
Hospital-
ization 
 
 
 
With 
Hospital- 
ization 
Without 
Hospital- 
ization 
 
With 
Hospital- 
ization 
Without 
Hospital- 
ization 
 
 
 
 
 
Unrelated 
Unlikely 
Not 
Required 
Not 
Required 
Not 
Required 
Not 
Required 
Not 
Required 
Not 
Required 
Not 
Required 
Not 
Required 
10  
Calendar 
Days 
 
Not 
Required 
10  
Calendar 
Days 
 
10 
Calendar 
Days 
 
Possible 
Probable 
Definite 
 
Not 
Required 
10 
Calendar 
Days 
 
Not 
Required 
Not 
Required 
10 
Calendar 
Days 
 
10 
Calendar 
Days 
 
Not 
Required 
Not 
Required 
24-Hour; 
5 Calendar 
Days 
10 
Calendar 
Days 
 
24-Hour; 
5 Calendar 
Days 
10 
Calendar 
Days 
 
 
 
Hospitalization is defined as initial hospitalization or prolongation of hospitalization for ≥ 24 hours, due to adverse event related to study procedures.  
 

URCC13070 Protocol 2017-04-25 
    
Page 31 of 56 
 
13.4.  Submit written adverse event reports in one of the following ways: 
 
(1)  PDF by email:  
Cathleen_lesniewski@urmc.rochester.edu 
(2)  By mail: 
Cathleen Lesniewski 
URCC NCORP Research Base  
Saunders Research Building 
265 Crittenden Blvd 
CU 420658 
Rochester, NY  14642 
(3)  By fax: 
Attn:  Cathleen Lesniewski   585-461-5601 
 
13.5.  An unexpected adverse event is defined as any adverse experience, the specificity or severity of which is not 
consistent with the risk information described in section 13.1.   
 
13.6.  A serious event refers to any event in which the outcome results in any of the following:  death, a life-
threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or 
significant disability, incapacity, or a congenital anomaly/birth defect.  Important medical events that may not 
result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience 
when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
 
13.7. ONLY serious adverse events related to the study procedures need to be reported for data and safety 
monitoring purposes.  AEs and SAEs related to routine oncology treatment and care DO NOT need to be 
reported.   
 
13.8.  Adverse events should be reported to the local IRB as per their requirements. 
 
13.9.  Data Safety and Monitoring 
 
13.9.1.  All adverse events requiring reporting will be submitted to the Research Base as described in section 
13.4.  Adverse events that are serious AND unexpected AND related will be forwarded to the study chair and 
the URCC Data Safety and Monitoring Committee (DSMC) chair immediately upon receipt at URCC.  
Additional information may be requested upon their review. 
 
13.9.2.  All adverse events reported to URCC are entered into a protocol-specific spreadsheet.  Adverse event 
rates are monitored utilizing the spreadsheet.  If a serious adverse event is being reported frequently, the study 
chair will conduct a detailed review.  The DSMC Committee Chair will be notified and will determine if 
further action is required. 
 
13.9.3.  The URCC Data Safety Monitoring Committee (DSMC) will review study progress and cumulative 
reports of adverse events at annual meetings.  An overall assessment of accrual and adverse events will enable 
the committee members to assess whether significant benefits or risks are occurring that would warrant study 
closure.   
 
13.9.4.  The URCC will notify the NCORPs immediately of any serious safety concerns identified by the 
DSMC.  DSMC reports will be available for download on the research base website. 
 
14.  CRITERIA FOR WITHDRAWAL  
 
Subjects who discontinue or are withdrawn from study will be asked to complete all assessment forms up until the 
time of withdrawal.   
 

URCC13070 Protocol 2017-04-25 
    
Page 32 of 56 
If an oncology physician withdraws from the study, no further patients with this oncology physician will be 
recruited.  Whenever possible, patients who have already been enrolled should complete study procedures and their 
data will be included in the analyses. 
 
Participation in this study is voluntary.  Participants are free not to take part or to withdraw at any time, for 
whatever reason, without risking loss of present or future care they would otherwise expect to receive.  In the event 
that a patient does withdraw from the study, the information they have already provided will be kept in a 
confidential manner.  Participants may discontinue participation in the study at any time if they decide they do not 
wish to take part any longer.  Participants may be withdrawn from the study by research personnel if it is deemed 
in their best interest to no longer participate. 
 
15.  STATISTICAL PLAN  
 
15.1.   Statistical Considerations 
 
This is a cluster-randomized trial with NCORP practice sites being the clusters.  Because of the cluster randomized 
study design, we will apply linear mixed model methodology.104  The outcome will be the response, and the arm 
will be the fixed effect.  NCORP practice sites will be entered as a random effect independent of residual error.  
Estimation will be performed using Restricted Maximum Likelihood, and the null hypothesis of zero mean 
difference between arms will be tested using a F test.105 The specific NCORP practice site differences will be 
assessed graphically using Best Linear Unbiased Predictors (BLUP) of the mean response for each NCORP. 
 
All regression analyses will include terms to control for study site and oncologist type. In addition, clinically 
important socioeconomic variables such as patient gender, age, race/ ethnicity, and cancer variables such as cancer 
type and treatment status will be used to control for patient-level covariates. In case a key covariate is found to be 
unbalanced between study arms, it will be included in the model as a potential confounder. 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 33 of 56 
15.2.   Sample Size for NCI-Specified Primary Aim 
We will utilize the modified 
HCCQ to address patient 
satisfaction with communication 
regarding age-related issues.  
Based on an analysis of the 
VOICE study, the standard 
deviation estimate of HCCQ was 
2.1. The Intracluster Correlation 
(ICC) was 0.14 with a 95% 
confidence interval from 0.01 to 
0.51.  Because of the large 
amount of uncertainty in the ICC, 
we calculated power curves for 
ICC={0.01, 0.14, 0.51}, with 
ICC=0.51 being the most 
conservative.  This design (8 sites 
per arm and 31 subjects per site) 
has 80% power at the 0.05 
significance level to detect a 
change in HCCQ of 0.6, 1.3 and 
2.3 for ICC={0.01, 0.14, 0.51}, 
respectively.  Since the best 
estimate of the ICC is 0.14, the 
expected detectable difference is 
1.3.  This corresponds to an effect 
size of 0.62.  The range of the 
HCCQ scores (modified HCCQ 
for satisfaction with age-related 
discussions) is 7 (worst possible) 
to 35 (best possible). The figure 
to the right shows the power for a 
range of detectable differences (D) for ICC=0.01, 0.14 and 0.51 (Figure 3). As mentioned in Section 7.1, small 
changes in satisfaction scores have been interpreted in other studies to be meaningful given a focus on achievement 
of high satisfaction scores and the link with reimbursement.  In addition to using the total score as a continuous 
variable, we will compare the results for each question as a dichotomous variable (5 vs <5).  If the distribution is 
skewed, we will consider treating the scores as an ordinal variable in analyses.   
 
Accounting for a small dropout rate of 5% (based on our observational cohort data1), the targeted accrual will be 
528 patient subjects total.  The dropout rate reflects patients who sign consent but withdraw prior to the audio-
recorded baseline visit and capture of the modified HCCQ (which will occur within 7 days of baseline visit).    
 
During NCORP site recruitment, if more than 16 NCORP sites are interested in participating, we will allow 
randomization.  As of February 1, 2017, we have 68 practice sites participating in the COACH study; the 
increased practice site clusters provide improved statistical power. The total patient sample size will stay the 
same, and accrual will cease when that target is met. 
 
Analysis for Primary Aim 1. This is a cluster randomized trial with NCORP practice sites being the clusters.  
Because of the cluster randomized study design, we will apply linear mixed model methodology.104  The total 
modified HCCQ scores (HCCQ-age) will be the response, and the arm will be the fixed effect.  NCORP practice 
sites will be entered as a random effect independent of residual error.  Estimation will be performed using 
Restricted Maximum Likelihood, and the null hypothesis of zero mean difference between arms will be tested 
using the F test.105  The specific practice site differences will be assessed graphically using Best Linear Unbiased 
Predictors (BLUP) of the mean response for each site. 
Power vs D by ICC 
S=2.100 M=8 N=31 Alpha=0.050 2-Sided T Test
D
0
1
2
3
4
0.0
0.2
0.4
0.6
0.8
1.0
ICC
0.010
0.140
0.510
Figure 3:  Sample Size for NCI-specified Primary Aim 

URCC13070 Protocol 2017-04-25 
    
Page 34 of 56 
 
15.3.  Secondary Aim 1 (PCORI-specified Primary Aim) 
 
An important secondary aim and the 
primary aimfor PCORI is the 
number of discussions related to 
geriatric domains, as measured by 
the GA, brought up during the 
audio-recorded baseline visit.  In our 
preliminary data from a multicenter 
study, the median number of 
discussions was 1 in 32 audio-
recorded conversations between 
older patients, their caregivers, and 
oncology physicians.  This 
preliminary work has allowed us to 
calculate the intracluster correlation 
(ICC) amongst 8 different sites for 
the assessment of the secondary 
outcome, number of discussions 
related to geriatric domains.  The 
ICC was 0.122 with a 95% 
confidence interval from 0.008 to 
0.659.  Because of the large amount 
of uncertainty in the ICC, we 
calculated power curves for 
ICC={0.008, 0.122, 0.659}, with 
ICC=0.659 being the most 
conservative.  This design (with 8 
NCORP sites per arm and 31 
evaluable subjects per  NCORP) has 
80% power at the 0.05 significance level to detect a change of 0.235, 0.456 and 0.962 in the mean number of 
discussions for ICC={0.008, 0.122, 0.659 } respectively, assuming a standard deviation of 0.78 (Figure 4). Since 
the best estimate of the ICC is 0.122, the expected detectable difference is 0.122.  This corresponds to an effect 
size of 0.59.   
 
The analysis for Secondary Aim 1 will be the same as for Primary Aim 1, but will use the number of discussions of 
age-related concerns as the response. 
 
 
15.4. Other Secondary Analyses  
 
15.4.1.  Secondary Aim 2:  HRQoL will be assessed with the FACT and Caregiver HRQoL will be assessed 
with the Caregiver Reactions Assessment (CRA).  The analysis will be the same as that used for Primary Aim 
1. We will include geriatric assessment impairment (at baseline and follow up) to evaluate if these influence 
patient-reported HRQoL differently in the intervention versus the control group.  We will also compare 
whether the uptake of geriatric assessment recommendations influences patient reported HRQoL and caregiver 
burden.  Data from the intervention arm will be fit to a linear mixed model with FACT or CRA as the outcome, 
number and percent of implemented interventions (number implemented/number recommended) as the fixed 
effect, and NCORP site as a random effect independent of residual error.  Analyses will be adjusted for 
treatment status. 
 
15.4.2.  Secondary Aim 3:  We will compare the effect of the intervention on caregiver satisfaction (the 
modified health care climate questionnaire for the caregiver) using the same linear mixed model methodology. 
Figure 4:  Sample Size for Secondary Aim 1 
(PCORI-specified Primary Aim) 

URCC13070 Protocol 2017-04-25 
    
Page 35 of 56 
 
15.4.3.  Exploratory Aims:  Exploratory aims will evaluate (1) whether the number of discussions about age-
related issues during the clinic visit correlates with patient satisfaction, (2) whether the intervention increases 
the proportion of age-related concerns that are acknowledged and addressed, and  (3)  if communication about 
age-related issues influences how patients, caregivers, and oncology physicians make decisions for cancer 
treatment.    An additional exploratory aim will examine the impact of the intervention on survival.   
 
In order to examine the relationship between observed communication from audio-recordings and patient 
satisfaction, we will evaluate the correlation between the numbers of discussions regarding age-related 
concerns from audio-recorded visits with patient satisfaction on HCCQ-age (modified to evaluate for 
satisfaction for communication about age-related issues).  We will determine the association of baseline 
oncology physician and patient decision-making preferences on the likelihood of having a discussion 
related to geriatric domains. The analysis for PCORI Primary Aim (secondary aim 1) will be used with the 
above characteristics added as independent variables. The statistical significance and estimated coefficients 
will be used to identify and interpret potentially important baseline features. Any conclusions will be 
considered to be hypothesis generating for further research. 
 
We will also measure the intervention increases the proportion of age-related issues that are acknowledged and 
addressed  (e.g., oncology physician response/(number of patient and caregiver concerns).  We will examine if 
the intervention improves physician confidence with managing age-related conditions as well as physician 
comfort with communication about age-related issues (using data from physician baseline and follow up 
forms) 
 
We will capture survival through the participant’s medical record and verification with the primary team.  We 
will follow participants for survival for 12 months after enrollment.  We will obtain the date, location of death, 
and cause of death. If a site becomes aware that a study participant is deceased, they should complete the 
withdrawal form if the survival status form  is not yet available on the URCC NCORP website. Otherwise sites 
will be contacted approximately 1 year after each participant was enrolled to assess survival and asked to 
complete this form.   We will determine the effect of the intervention on 12-month survival using log rank tests 
and survival plots. 
 
 
15.5.  Missing Data 
Every effort will be made to encourage and facilitate participants' completion of questionnaires, but because of 
dropout, missing data will occur.  We will evaluate the patterns of missing data and associations of missingness 
with other available variables. Under the missing at random (MAR) assumption, the parameter estimates from the 
mixed model analyses will be unbiased. If the data are suspected to be missing not at random (MNAR), a 
sensitivity analysis using selection and/or pattern-mixture models will be run to determine the impact on the 
results.106  If the estimates are similar to the ones obtained from the simpler analysis of only complete cases, we 
will report the complete-case analysis results.  
 
16.  DATA MANAGEMENT AND QUALITY ASSURANCE 
 
16.1. Training Procedures 
A special training session was held at the 2013 annual URCC NCORP Research Base meeting.  This training 
included a detailed review of the study rationale, design, and research administration procedures. Training sessions 
will be held with the staff from each site via teleconference and at the annual meetings.  These sessions and the 
corresponding procedures manuals review the following:  1) informed consent; 2) completing the assessments 
using Teleforms; 3) completing the functional and objective measures; 4) data collection via chart extraction; 5) 
completing the web-based intervention using mycarg.org (for intervention arm); 6) transfer of the data to the 
URCC NCORP Research Base; 7) formulating the research chart; and 8) a discussion of interviewing techniques 
so that the research team will standardize their approaches in order to elicit consistent data from subjects. There 
will be a protocol update every year at the annual Research Base meeting.  All assessments, data collection forms, 
and manuals will be readily available on the NCORP Research Base website.   

URCC13070 Protocol 2017-04-25 
    
Page 36 of 56 
  
16.2.  Data Management 
The same protocols and procedures for data quality and control that we use for all URCC NCORP Research Base 
protocols (which accrued over 1,000 patients in the previous year) will be used for this study. Once the patient 
consents to the protocol, he/she will be assigned a unique identifier by the Research Base, which will be used to 
link all patient data.  Oncology physician and patient assessments will be captured using scannable Teleforms. The 
CRA and/or Research Nurse at each site will ensure that data are complete prior to submission.  At the Research 
Base, data are scanned into an electronic password-secured Access database which is backed up every 24 hours.  
At the Research Base, staff to ensure that all data are collected in order to minimize missing data by employing 
multi-step verification procedures and querying originating sites for missing or ambiguous data.  Audio-recordings 
will be submitted to the Research Base within 24 hours and stored securely as source documentations in 
accordance with HIPAA compliance.  Audio-recordings will be transcribed and de-identified by persons who are 
not direct members of the study staff.   
 
16.3.  REDCap 
Data are also collected and managed by the URCC Research Base using REDCap electronic data capture tools 
hosted at the University of Rochester Medical Center (URMC). We will evaluate records, clinical characteristics, 
and outcomes and we will utilize REDCap to collect and manage this information. Further, we will link this 
information to the encrypted ACCESS database (which contains the survey information) with a unique identifier.   
 
16.3.1. The University of Rochester Medical Center provides the following information on the REDCap 
program:  “Vanderbilt University, in collaboration with a consortium of institutional partners, has developed 
a software toolset and workflow methodology for electronic collection and management of research and 
clinical trial data, called REDCap (Research Electronic Data Capture). The REDCap system is a secure, web-
based application that is flexible enough to be used for a variety of types of research.  It provides an intuitive 
interface for users to enter data and real time validation rules (with automated data type and range checks) at 
the time of data entry. REDCap offers easy data manipulation with audit trails and functionality for reporting, 
monitoring and querying patient records, as well as an automated export mechanism to common statistical 
packages (SPSS, SAS, Stata, R/S-Plus). Through the REDCap Consortium, Vanderbilt has disseminated 
REDCap for use around the world. Currently, over 240 academic and non-profit consortium partners on six 
continents with over 26,000 research end-users use REDCap”  
 
16.3.2. According to the University of Rochester Clinical and Translational Science Institute (CTSI), 
REDCap is supported with the following means. “The CTSI Informatics Core, a unit of the SMD Academic 
Information Technology (AIT) Group, will serve as a central facilitator for data processing and 
management.  REDCap data collection projects rely on a thorough study-specific data dictionary defined in an 
iterative self-documenting process by all members of the research team, with planning assistance from the AIT-
CTSI Informatics Core.  The iterative development and testing process results in a well-planned data collection 
strategy for individual studies.”  
 
16.3.3. The CTSI states that regarding security, “REDCap servers are housed in a local data center at the 
University of Rochester and all web-based information transmission is encrypted. REDCap was developed in a 
manner consistent with HIPAA security requirements and is recommended to University of Rochester 
researchers by the URMC Research Privacy Officer and Office for Human Subject Protection. 
 
16.4.  Data Storage: 
All written materials will be kept confidential, locked in the private offices and limited-access file room of the 
URCC NCORP Research Base and identified by ID numbers.  All electronic information will be kept confidential 
with password-protected, limited access. 
 
The Case Summary should accompany ALL data submissions.  All completed forms and audio-recordings must be 
submitted within 7 days of the study visit and should be sent to: 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 37 of 56 
Libby Nagalski 
URCC NCORP Research Base  
Saunders Research Building 
265 Crittenden Blvd 
Box CU 420658 
Rochester, NY 14642 
 
17. DATA COLLECTION AND MEASURES 
 
For a detailed description of the measures that will be collected, refer to Appendix X-1:  Measures. 
 
18.  SUBJECT CONSENT AND PEER JUDGMENT 
 
All investigational, FDA, state, federal and institutional regulations concerning informed consent and peer 
judgment will be fulfilled. 
 
19.  RECORD AND DATA RETENTION 
 
Clinical research records are source documents and records, in any form (including, but not limited to, written, 
electronic, magnetic, and optical records, in addition, scans (x-rays and electrocardiograms) that describe or record 
the methods, conduct, and/or results of a trial, and the actions taken. Unlike pharmaceutical-sponsored research, 
under the Terms of the NIH Award, the awardee institution retains ownership of the clinical research records that 
were conducted with NIH support. Records may be preserved in hardcopy, electronic or other media form since 
there is no regulatory requirement that clinical research records be retained in a certain type of format. However, 
investigators should check with their institution for institutional policies and procedures pertaining to record 
retention. All records relating to research that is conducted must be retained for at least five years after completion 
of the research. The three-year time period begins when the individual institution’s engagement in the human 
subjects research activity ends. Human subject research activities are considered completed once all research-
related interventions and interactions with human subjects have been completed, all data collection and analysis of 
identifiable private information described in the IRB-approved research plan have been finished and primary 
analysis of either identifiable private or de-identified information is completed.  
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 38 of 56 
20.  REFERENCES 
1. 
Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with 
cancer: a prospective multicenter study. Journal of clinical oncology : official journal of the 
American Society of Clinical Oncology. Sep 1 2011;29(25):3457-3465. 
2. 
Rodin MB, Mohile SG. A practical approach to geriatric assessment in oncology. Journal of 
clinical oncology : official journal of the American Society of Clinical Oncology. May 10 
2007;25(14):1936-1944. 
3. 
Mohile S, Dale W, Hurria A. Geriatric oncology research to improve clinical care. Nature 
reviews. Clinical oncology. Jul 24 2012;9(10):571-578. 
4. 
Rao AV, Hsieh F, Feussner JR, Cohen HJ. Geriatric evaluation and management units in the care 
of the frail elderly cancer patient. J Gerontol A Biol Sci Med Sci. Jun 2005;60(6):798-803. 
5. 
Caillet P, Canoui-Poitrine F, Vouriot J, et al. Comprehensive geriatric assessment in the decision-
making process in elderly patients with cancer: ELCAPA study. J Clin Oncol. Sep 20 
2011;29(27):3636-3642. 
6. 
Ingram SS, Seo PH, Martell RE, et al. Comprehensive assessment of the elderly cancer patient: 
the feasibility of self-report methodology. J Clin Oncol. Feb 1 2002;20(3):770-775. 
7. 
Hurria A, Gupta S, Zauderer M, et al. Developing a cancer-specific geriatric assessment: a 
feasibility study. Cancer. Nov 1 2005;104(9):1998-2005. 
8. 
Dale W, Mohile SG, Eldadah BA, et al. Biological, clinical, and psychosocial correlates at the 
interface of cancer and aging research. J Natl Cancer Inst. Apr 18 2012;104(8):581-589. 
9. 
Hurria A, Balducci L, Naeim A, et al. Mentoring junior faculty in geriatric oncology: report from 
the Cancer and Aging Research Group. J Clin Oncol. Jul 1 2008;26(19):3125-3127. 
10. 
Hurria A, Mohile SG, Dale W. Research priorities in geriatric oncology: addressing the needs of 
an aging population. J Natl Compr Canc Netw. Feb 2012;10(2):286-288. 
11. 
Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. Sep-Oct;60(5):277-
300. 
12. 
Smith BD, Smith GL, Hurria A, Hortobagyi GN, Buchholz TA. Future of Cancer Incidence in the 
United States: Burdens Upon an Aging, Changing Nation. Journal of Clinical Oncology. June 10, 
2009 2009;27(17):2758-2765. 
13. 
Dale W, Mohile SG, Eldadah BA, et al. Biological, clinical, and psychosocial correlates at the 
interface of cancer and aging research. J Natl Cancer Inst. Apr 18 2012;104(8):581-589. 
14. 
Mohile S, Dale W, Hurria A. Geriatric oncology research to improve clinical care. Nature 
reviews. Clinical oncology. Jul 24 2012. 
15. 
Mohile SG, Xian Y, Dale W, et al. Association of a cancer diagnosis with vulnerability and frailty 
in older Medicare beneficiaries. Journal of the National Cancer Institute. Sep 2 
2009;101(17):1206-1215. 
16. 
Mohile SG, Fan L, Reeve E, et al. Association of cancer with geriatric syndromes in older 
Medicare beneficiaries. J Clin Oncol. Apr 10 2011;29(11):1458-1464. 
17. 
Crome P, Flanagan RJ. Pharmacokinetic studies in elderly people. Are they necessary? Clin 
Pharmacokinet. Apr 1994;26(4):243-247. 
18. 
Fried TR, Bradley EH, Towle VR, Allore H. Understanding the treatment preferences of seriously 
ill patients. The New England journal of medicine. Apr 4 2002;346(14):1061-1066. 
19. 
Keating NL, Norredam M, Landrum MB, Huskamp HA, Meara E. Physical and mental health 
status of older long-term cancer survivors. J Am Geriatr Soc. Dec 2005;53(12):2145-2152. 
20. 
Maione P, Perrone F, Gallo C, et al. Pretreatment quality of life and functional status assessment 
significantly predict survival of elderly patients with advanced non-small-cell lung cancer 
receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly 
study. Journal of clinical oncology : official journal of the American Society of Clinical 
Oncology. Oct 1 2005;23(28):6865-6872. 

URCC13070 Protocol 2017-04-25 
    
Page 39 of 56 
21. 
Stafford RS, Cyr PL. The impact of cancer on the physical function of the elderly and their 
utilization of health care. Cancer. Nov 15 1997;80(10):1973-1980. 
22. 
Audisio RA, Gennari R, Sunouchi K, et al. Preoperative assessment of cancer in elderly patients: 
a pilot study. Supportive cancer therapy. Oct 1 2003;1(1):55-60. 
23. 
Guralnik JM, Simonsick EM, Ferrucci L, et al. A short physical performance battery assessing 
lower extremity function: association with self-reported disability and prediction of mortality and 
nursing home admission. Journal of gerontology. Mar 1994;49(2):M85-94. 
24. 
Bylow K, Hemmerich J, Mohile SG, Stadler WM, Sajid S, Dale W. Obese frailty, physical 
performance deficits, and falls in older men with biochemical recurrence of prostate cancer on 
androgen deprivation therapy: a case-control study. Urology. Apr 2011;77(4):934-940. 
25. 
Stone CA, Lawlor PG, Savva GM, Bennett K, Kenny RA. Prospective study of falls and risk 
factors for falls in adults with advanced cancer. J Clin Oncol. Jun 10 2012;30(17):2128-2133. 
26. 
Extermann M, Balducci L, Lyman GH. What threshold for adjuvant therapy in older breast cancer 
patients? J Clin Oncol. Apr 2000;18(8):1709-1717. 
27. 
Frasci G, Lorusso V, Panza N, et al. Gemcitabine plus vinorelbine versus vinorelbine alone in 
elderly patients with advanced non-small-cell lung cancer. J Clin Oncol. Jul 2000;18(13):2529-
2536. 
28. 
Firat S, Byhardt RW, Gore E. Comorbidity and Karnofksy performance score are independent 
prognostic factors in stage III non-small-cell lung cancer: an institutional analysis of patients 
treated on four RTOG studies. Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys. 
Oct 1 2002;54(2):357-364. 
29. 
Piccirillo JF, Tierney RM, Costas I, Grove L, Spitznagel EL, Jr. Prognostic importance of 
comorbidity in a hospital-based cancer registry. JAMA. May 26 2004;291(20):2441-2447. 
30. 
Satariano WA, Ragland DR. The effect of comorbidity on 3-year survival of women with primary 
breast cancer. Ann Intern Med. Jan 15 1994;120(2):104-110. 
31. 
Gronberg BH, Sundstrom S, Kaasa S, et al. Influence of comorbidity on survival, toxicity and 
health-related quality of life in patients with advanced non-small-cell lung cancer receiving 
platinum-doublet chemotherapy. Eur J Cancer. Aug 2010;46(12):2225-2234. 
32. 
Jung SY, Rosenzweig M, Linkov F, Brufsky A, Weissfeld JL, Sereika SM. Comorbidity as a 
Mediator of Survival Disparity Between Younger and Older Women Diagnosed With Metastatic 
Breast Cancer. Hypertension. Dec 19 2011. 
33. 
Albertsen PC, Moore DF, Shih W, Lin Y, Li H, Lu-Yao GL. Impact of comorbidity on survival 
among men with localized prostate cancer. J Clin Oncol. Apr 1 2011;29(10):1335-1341. 
34. 
Steyerberg EW, Neville BA, Koppert LB, et al. Surgical mortality in patients with esophageal 
cancer: development and validation of a simple risk score. J Clin Oncol. Sep 10 
2006;24(26):4277-4284. 
35. 
Maggiore RJ, Gross CP, Hurria A. Polypharmacy in older adults with cancer. Oncologist. 
2010;15(5):507-522. 
36. 
Landi F, Zuccala G, Gambassi G, et al. Body mass index and mortality among older people living 
in the community. J Am Geriatr Soc. Sep 1999;47(9):1072-1076. 
37. 
Dewys WD, Begg C, Lavin PT, et al. Prognostic effect of weight loss prior to chemotherapy in 
cancer patients. Eastern Cooperative Oncology Group. Am J Med. Oct 1980;69(4):491-497. 
38. 
Wadley VG, Okonkwo O, Crowe M, Ross-Meadows LA. Mild cognitive impairment and 
everyday function: evidence of reduced speed in performing instrumental activities of daily 
living. Am J Geriatr Psychiatry. May 2008;16(5):416-424. 
39. 
Sauvaget C, Yamada M, Fujiwara S, Sasaki H, Mimori Y. Dementia as a predictor of functional 
disability: a four-year follow-up study. Gerontology. Jul-Aug 2002;48(4):226-233. 

URCC13070 Protocol 2017-04-25 
    
Page 40 of 56 
40. 
Dodge HH, Kadowaki T, Hayakawa T, Yamakawa M, Sekikawa A, Ueshima H. Cognitive 
impairment as a strong predictor of incident disability in specific ADL-IADL tasks among 
community-dwelling elders: the Azuchi Study. The Gerontologist. Apr 2005;45(2):222-230. 
41. 
Hurria A, Li D, Hansen K, et al. Distress in older patients with cancer. J Clin Oncol. Sep 10 
2009;27(26):4346-4351. 
42. 
Seeman TE, Berkman LF, Kohout F, Lacroix A, Glynn R, Blazer D. Intercommunity variations in 
the association between social ties and mortality in the elderly. A comparative analysis of three 
communities. Ann Epidemiol. Jul 1993;3(4):325-335. 
43. 
Kroenke CH, Kubzansky LD, Schernhammer ES, Holmes MD, Kawachi I. Social networks, 
social support, and survival after breast cancer diagnosis. J Clin Oncol. Mar 1 2006;24(7):1105-
1111. 
44. 
Kornblith AB, Herndon JE, 2nd, Zuckerman E, et al. Social support as a buffer to the 
psychological impact of stressful life events in women with breast cancer. Cancer. Jan 15 
2001;91(2):443-454. 
45. 
Extermann M, Overcash J, Lyman GH, Parr J, Balducci L. Comorbidity and functional status are 
independent in older cancer patients. J Clin Oncol. Apr 1998;16(4):1582-1587. 
46. 
Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hebert R, Hogan DB. A brief clinical 
instrument to classify frailty in elderly people. Lancet. Jan 16 1999;353(9148):205-206. 
47. 
Reuben DB, Rubenstein LV, Hirsch SH, Hays RD. Value of functional status as a predictor of 
mortality: results of a prospective study. Am J Med. Dec 1992;93(6):663-669. 
48. 
Dale W. "Staging the aging" when considering androgen deprivation therapy for older men with 
prostate cancer. Journal of clinical oncology : official journal of the American Society of Clinical 
Oncology. Jul 20 2009;27(21):3420-3422. 
49. 
Extermann M, Hurria A. Comprehensive geriatric assessment for older patients with cancer. 
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. May 
10 2007;25(14):1824-1831. 
50. 
Hurria A, Lichtman SM, Gardes J, et al. Identifying vulnerable older adults with cancer: 
integrating geriatric assessment into oncology practice. Journal of the American Geriatrics 
Society. Oct 2007;55(10):1604-1608. 
51. 
Repetto L, Fratino L, Audisio RA, et al. Comprehensive geriatric assessment adds information to 
Eastern Cooperative Oncology Group performance status in elderly cancer patients: an Italian 
Group for Geriatric Oncology Study. J Clin Oncol. Jan 15 2002;20(2):494-502. 
52. 
Kanesvaran R, Li H, Koo KN, Poon D. Analysis of Prognostic Factors of Comprehensive 
Geriatric Assessment and Development of a Clinical Scoring System in Elderly Asian Patients 
With Cancer. J Clin Oncol. Aug 22 2011. 
53. 
Horgan AM, Leighl NB, Coate L, et al. Impact and Feasibility of a Comprehensive Geriatric 
Assessment in the Oncology Setting: A Pilot Study. Am J Clin Oncol. Mar 17 2011. 
54. 
Hurria A, Cirrincione CT, Muss HB, et al. Implementing a geriatric assessment in cooperative 
group clinical cancer trials: CALGB 360401. Journal of clinical oncology : official journal of the 
American Society of Clinical Oncology. Apr 1 2011;29(10):1290-1296. 
55. 
Hurria A, Cohen HJ, Extermann M. Geriatric Oncology Research in the Cooperative Groups: A 
Report of a SIOG Special Meeting. Journal of geriatric oncology. Jun 1 2010;1(1):40-44. 
56. 
Pal SK, Katheria V, Hurria A. Evaluating the older patient with cancer: understanding frailty and 
the geriatric assessment. CA: a cancer journal for clinicians. Mar-Apr 2010;60(2):120-132. 
57. 
Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life 
assessments and patient-physician communication: a randomized controlled trial. JAMA : the 
journal of the American Medical Association. Dec 18 2002;288(23):3027-3034. 

URCC13070 Protocol 2017-04-25 
    
Page 41 of 56 
58. 
Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Role of health-related quality 
of life in palliative chemotherapy treatment decisions. Journal of clinical oncology : official 
journal of the American Society of Clinical Oncology. Feb 15 2002;20(4):1056-1062. 
59. 
Weeks JC, Catalano PJ, Cronin A, et al. Patients' expectations about effects of chemotherapy for 
advanced cancer. The New England journal of medicine. Oct 25 2012;367(17):1616-1625. 
60. 
Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-
small-cell lung cancer. N Engl J Med. Aug 19 2010;363(8):733-742. 
61. 
Cohen HJ, Feussner JR, Weinberger M, et al. A controlled trial of inpatient and outpatient 
geriatric evaluation and management. N Engl J Med. Mar 21 2002;346(12):905-912. 
62. 
Stuck AE, Siu AL, Wieland GD, Adams J, Rubenstein LZ. Comprehensive geriatric assessment: a 
meta-analysis of controlled trials. Lancet. Oct 23 1993;342(8878):1032-1036. 
63. 
Stuck AE, Aronow HU, Steiner A, et al. A trial of annual in-home comprehensive geriatric 
assessments for elderly people living in the community. N Engl J Med. Nov 2 
1995;333(18):1184-1189. 
64. 
McCorkle R, Strumpf NE, Nuamah IF, et al. A specialized home care intervention improves 
survival among older post-surgical cancer patients. J Am Geriatr Soc. Dec 2000;48(12):1707-
1713. 
65. 
Goodwin JS, Satish S, Anderson ET, Nattinger AB, Freeman JL. Effect of nurse case 
management on the treatment of older women with breast cancer. J Am Geriatr Soc. Sep 
2003;51(9):1252-1259. 
66. 
Seymour MT, Thompson LC, Wasan HS, et al. Chemotherapy options in elderly and frail patients 
with metastatic colorectal cancer (MRC FOCUS2): an open-label, randomised factorial trial. 
Lancet. May 21 2011;377(9779):1749-1759. 
67. 
Arora NK, Street RL, Jr., Epstein RM, Butow PN. Facilitating patient-centered cancer 
communication: a road map. Patient education and counseling. Dec 2009;77(3):319-321. 
68. 
Shields CG, Coker CJ, Poulsen SS, et al. Patient-centered communication and prognosis 
discussions with cancer patients. Patient education and counseling. Dec 2009;77(3):437-442. 
69. 
Street RL, Jr., Makoul G, Arora NK, Epstein RM. How does communication heal? Pathways 
linking clinician-patient communication to health outcomes. Patient education and counseling. 
Mar 2009;74(3):295-301. 
70. 
Street RL, Jr., Elwyn G, Epstein RM. Patient preferences and healthcare outcomes: an ecological 
perspective. Expert review of pharmacoeconomics & outcomes research. Apr 2012;12(2):167-
180. 
71. 
Andreozzi J, Dale W, Fan L, Mohile SG. Feasibility of Incorporting Geriatric Assessment into 
Oncology Practice in Real-Time. American Geriatrics Society National Meeting. 2011(D104). 
72. 
Guigoz Y. The Mini Nutritional Assessment (MNA) review of the literature--What does it tell us? 
The journal of nutrition, health & aging. Nov-Dec 2006;10(6):466-485; discussion 485-467. 
73. 
Yesavage JA, Brink TL, Rose TL, et al. Development and validation of a geriatric depression 
screening scale: a preliminary report. Journal of psychiatric research. 1982;17(1):37-49. 
74. 
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short 
Orientation-Memory-Concentration Test of cognitive impairment. The American journal of 
psychiatry. Jun 1983;140(6):734-739. 
75. 
Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in 
persons over the age of 70 years as a predictor of subsequent disability. The New England journal 
of medicine. Mar 2 1995;332(9):556-561. 
76. 
Epstein RM, Franks P, Fiscella K, et al. Measuring patient-centered communication in patient-
physician consultations: theoretical and practical issues. Social science & medicine. Oct 
2005;61(7):1516-1528. 

URCC13070 Protocol 2017-04-25 
    
Page 42 of 56 
77. 
Epstein RM, Alper BS, Quill TE. Communicating evidence for participatory decision making. 
JAMA. May 19 2004;291(19):2359-2366. 
78. 
Epstein RM, Street RL, Jr. Shared mind: communication, decision making, and autonomy in 
serious illness. Annals of family medicine. Sep-Oct 2011;9(5):454-461. 
79. 
Young HN, Bell RA, Epstein RM, Feldman MD, Kravitz RL. Physicians' shared decision-making 
behaviors in depression care. Arch Intern Med. Jul 14 2008;168(13):1404-1408. 
80. 
Dale W, Hemmerich J, Bylow K, Mohile S, Mullaney M, Stadler WM. Patient anxiety about 
prostate cancer independently predicts early initiation of androgen deprivation therapy for 
biochemical cancer recurrence in older men: a prospective cohort study. Journal of clinical 
oncology : official journal of the American Society of Clinical Oncology. Apr 1 
2009;27(10):1557-1563. 
81. 
Velikova G, Booth L, Smith AB, et al. Measuring quality of life in routine oncology practice 
improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. Feb 
15 2004;22(4):714-724. 
82. 
Williams GC, Deci EL. The importance of supporting autonomy in medical education. Annals of 
internal medicine. Aug 15 1998;129(4):303-308. 
83. 
Williams GC, McGregor HA, Sharp D, et al. Testing a self-determination theory intervention for 
motivating tobacco cessation: supporting autonomy and competence in a clinical trial. Health 
psychology : official journal of the Division of Health Psychology, American Psychological 
Association. Jan 2006;25(1):91-101. 
84. 
Vallerand RJ, O'Connor BP, Blais MR. Life satisfaction of elderly individuals in regular 
community housing, in low-cost community housing, and high and low self-determination 
nursing homes. International journal of aging & human development. 1989;28(4):277-283. 
85. 
Fiscella K, Franks P, Srinivasan M, Kravitz RL, Epstein R. Ratings of physician communication 
by real and standardized patients. Annals of family medicine. Mar-Apr 2007;5(2):151-158. 
86. 
Zafar SY, Malin JL, Grambow SC, et al. Chemotherapy use and patient treatment preferences in 
advanced colorectal cancer: a prospective cohort study. Cancer. Feb 15 2013;119(4):854-862. 
87. 
Safran DG, Karp M, Coltin K, et al. Measuring patients' experiences with individual primary care 
physicians. Results of a statewide demonstration project. Journal of general internal medicine. 
Jan 2006;21(1):13-21. 
88. 
Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare benchmarks 
and quality improvement. Dec 2008;15(12):121-123. 
89. 
Cowan P. Press Ganey scores and patient satisfaction in the emergency department (ED): the 
patient perspective. Pain medicine. Jul 2013;14(7):969. 
90. 
Zusman EE. HCAHPS replaces Press Ganey survey as quality measure for patient hospital 
experience. Neurosurgery. Aug 2012;71(2):N21-24. 
91. 
Hoerger M, Epstein RM, Winters PC, et al. Values and options in cancer care (VOICE): study 
design and rationale for a patient-centered communication and decision-making intervention for 
physicians, patients with advanced cancer, and their caregivers. BMC cancer. 2013;13:188. 
92. 
http://www.hcahpsonline.org. Centers for Medicare & Medicaid Services, Baltimore, MD. 
93. 
Reid RJ, Coleman K, Johnson EA, et al. The Group Health medical home at year two: cost 
savings, higher patient satisfaction, and less burnout for providers. Health affairs. May 
2010;29(5):835-843. 
94. 
Grunfeld E, Fitzpatrick R, Mant D, et al. Comparison of breast cancer patient satisfaction with 
follow-up in primary care versus specialist care: results from a randomized controlled trial. Brit J 
Gen Pract. Sep 1999;49(446):705-710. 
95. 
Morris BJ, Richards JE, Archer KR, et al. Improving Patient Satisfaction in the Orthopaedic 
Trauma Population. Journal of orthopaedic trauma. Oct 28 2013. 

URCC13070 Protocol 2017-04-25 
    
Page 43 of 56 
96. 
Clayton JM, Butow PN, Tattersall MH, et al. Randomized controlled trial of a prompt list to help 
advanced cancer patients and their caregivers to ask questions about prognosis and end-of-life 
care. J Clin Oncol. Feb 20 2007;25(6):715-723. 
97. 
Butow P, Cockburn J, Girgis A, et al. Increasing oncologists' skills in eliciting and responding to 
emotional cues: evaluation of a communication skills training program. Psychooncology. Mar 
2008;17(3):209-218. 
98. 
Detmar SB. Use of HRQOL questionnaires to facilitate patient-physician communication. Expert 
review of pharmacoeconomics & outcomes research. Jun 2003;3(3):215-217. 
99. 
Brucker PS, Yost K, Cashy J, Webster K, Cella D. General population and cancer patient norms 
for the Functional Assessment of Cancer Therapy-General (FACT-G). Evaluation & the health 
professions. Jun 2005;28(2):192-211. 
100. 
Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer Therapy scale: 
development and validation of the general measure. J Clin Oncol. Mar 1993;11(3):570-579. 
101. 
Temel JS, Jackson VA, Billings JA, et al. Phase II study: integrated palliative care in newly 
diagnosed advanced non-small-cell lung cancer patients. J Clin Oncol. Jun 10 2007;25(17):2377-
2382. 
102. 
Temel J. Complexities of quality of life analysis in non-small cell lung cancer. J Support Oncol. 
Jan 2007;5(1):30-31. 
103. 
Given CW, Given B, Stommel M, Collins C, King S, Franklin S. The caregiver reaction 
assessment (CRA) for caregivers to persons with chronic physical and mental impairments. Res 
Nurs Health. Aug 1992;15(4):271-283. 
104. 
Brown H, Prescott R. Applied Mixed Models in Medicine. 2nd edition ed. Edinburgh, UK: John 
Wiley and Sons, Ltd; 2006. 
105. 
Kenward MG, Roger JH. Small sample inference for fixed effects from restricted maximum 
likelihood. Biometrics. Sep 1997;53(3):983-997. 
106. 
Little R, Rubin D. Stastical analysis with missing data. 2nd edition 
 ed. Hoboken, NJ: Wiley; 2002. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 44 of 56 
 
 
 
 
 
 
 
 
APPENDIX X-1 
 
MEASURES 
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 45 of 56 
MEASURES TO BE COLLECTED 
Collection Time-points are Screening/Baseline, Telephone Team Call to patient within 1 to 7 days 
from baseline to assess patient satisfaction, 4-6 weeks, 10-14 weeks (3 months) and 20-24 weeks (6 
months).   Measures signified by *** are only collected at screening/baseline and not at follow-up 
visits.  Measures signified by (Follow-up) are collected only at follow-up visits. 
We have piloted all measures.  In total, geriatric assessment measures that are filled out by the patient 
require approximately 20 minutes of time.  The additional measures (quality of life, symptoms, 
communication, decision-making) captured at baseline require an additional 30 minutes of time.  The 
follow-up questionnaires require about 30 minutes of time in total.  Caregiver assessments require about 
30 minutes of time. 
We have incorporated flexibility with timing in order to reduce patient burden.  Patients and caregivers 
may complete geriatric assessment at clinic at time of consent or before next visit.  They may choose to 
complete measures at home in between visits.  We have found that 90% of patients complete measures at 
home if allowed to do so.  The geriatric oncology clinic at the University of Rochester routinely captures 
these measures as part of clinical care. 
The telephone call that will capture the patient satisfaction measures (based on the Health Care Climate 
Questionnaire, HCCQ) will take <10 minutes and will occur within 1 to 7 days of the baseline audiotaped 
visit.  The assessments performed by the Clinical Research Associate take about 30 to 45 minutes of time 
in total (including physical performance and cognitive tests).  Any person at the practice site can be 
trained by Research Base staff to do the assessments.  The assessments do not need to be performed by 
the physician. 
The physician assessments will be done either on paper or through REDCap, whichever the physician 
prefers.  The baseline assessments take no longer than 10 minutes and after each patient visit, the 
decision-making form (to assess factors that influenced decisions) is less than one-page long (2 minutes 
to complete). 
 
1. Patient Surveys 
1.1. Demographics***:  Age, race and ethnicity, gender, highest level of education achieved, 
employment status, marital status, living situation, and presence of a living companion will be 
captured.  We will also assess financial concerns, understanding of disease, self-rated health, and 
subjective age. 
1.2. Geriatric assessment:  Assessment tools comprising the comprehensive geriatric assessment are 
discussed below.  The various assessment tools were selected based upon extensive data in the 
geriatric literature demonstrating predictive value as well as feasibility data in multiple studies of 
elderly patients with cancer.  Other than the cognitive and physical performance measures, the 
assessments are self-administered.   Patients who cannot complete the assessment on their own can 
receive assistance from the study personnel or caregiver. The comprehensive assessment is 
performed first prior to treatment and brief follow-up GA measures are collected at 4-6 weeks, 3 
months, and 6 months.  Measures collected only at baseline are noted with ***.   
1.2.1.   Activities of daily living (ADL):1  ADLs are measures of self-care. ADL independence will 
be assessed using the Katz Index of Independence in Activities of Daily Living, commonly 
referred to as the Katz ADL. The Katz ADL is the most appropriate instrument to assess   
         
functional status as a measurement of the patient’s ability to perform activities of daily living 
independently. Clinicians typically use the tool to detect problems in performing activities of daily 
living and to plan care accordingly. The Index ranks adequacy of performance in the six functions 

URCC13070 Protocol 2017-04-25 
    
Page 46 of 56 
of bathing, dressing, toileting, transferring, continence, and feeding.   Patients are scored yes/no 
for independence in each of the six functions. A score of 6 indicates full function, 4 indicates 
moderate impairment, and 2 or less indicates severe functional impairment.   
1.2.2. Instrumental Activities of Daily Living (IADL):2  Self-reported functional status will be 
assessed using the IADL subscale of the Multidimensional Functional Assessment Questionnaire:  
Older American Resources and Services (OARS).  The IADL subscale consists of seven questions 
rated on a three-point Likert scale.  It measures the degree to which an activity can be performed 
independently. 
1.2.3. Fall History: A self-reported history of falls in the past six months will be recorded.  A 
history of a recent fall has been demonstrated to be independently predictive of increased risk for 
chemotherapy toxicity in older cancer patients.3 
1.2.4. OARS Physical Health:2  Self-reported questions that assess the degree of difficulty with 
physical tasks such as walking, climbing stairs, stooping, and reaching.  This measure correlates 
with disability and comorbidity. 
1.2.5. OARS Comorbidity***:2  Patients self-report their coexisting medical conditions and also 
rate the degree to which their illness causes impairment in daily activities.  The OARS Physical 
Health Section has been shown to correlate significantly with health professional ratings of 
comorbidity as well.  
1.2.6.  OARS Medical Social Support and Social Activities:***2  A 13-question survey asking 
patients to identify the number of support persons involved in their medical care as well as the 
degree to which they felt supported in a variety of situations.  A follow-up question will be used to 
assess how much a patient’s physical or emotional health interfered with social activities. 
1.2.7.  Generalized Anxiety Disorder 7 (GAD-7):***4  The GAD-7 is a self-administered patient 
questionnaire used as a screening tool and severity measure for generalized anxiety disorder. The 
GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 
“hardly ever,” “several days,” “more than half the days,” and “nearly every day,” respectively, and 
adding together the scores for the seven questions.  Scores of 5, 10, and 15 are taken as the cut off 
points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further 
evaluation is recommended when the score is 10 or greater.  Using the threshold score of 10, the 
GAD-7 has a sensitivity of 89% and a specificity of 82% for generalized anxiety disorder.  It is 
moderately good at screening three other common anxiety disorders – panic disorder (sensitivity 
74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%), and post-
traumatic stress disorder (sensitivity 66%, specificity 81%).  
1.2.8.  Geriatric Depression Scale (GDS):5   Patients will be screened with the Geriatric 
Depression Scale (GDS). The GDS contains questions that are intended to screen elderly patients 
for depression, while parsing out complaints related to advanced age.6  
1.3. Satisfaction, Quality of Life, and Symptoms: 
1.3.1.  Health Care Climate Questionnaire (HCCQ) (Follow-up)7-9 measures patient- centered 
autonomy-supportive physician behaviors such as whether the patient and caregiver feels that the 
physician understands his/her perspective, provides choices and options, and encourages 
participation in decisions.  The measure has been studied and validated in older patients. Similar to 
other studies which adapt satisfaction scales to capture specific clinical criteria (e.g., satisfaction 
with physician regarding communication about chemotherapy),10 the HCCQ has been modified for 
this study to specifically address patient satisfaction with physician behaviors and communication 
regarding age-related issues and concerns in order to specifically address satisfaction with the 

URCC13070 Protocol 2017-04-25 
    
Page 47 of 56 
intervention (geriatric assessment summary) rather than satisfaction with other aspects of cancer 
care (e.g., communication about cancer treatment)(HCCQ-age).   As is done with satisfaction with 
care surveys in other research and in clinical settings, the HCCQ (both modified and original) will 
be administered within 1 week after the audio-taped clinic visit.11-14   Our University of Chicago 
collaborators (Dale and Gorawara-Bhatt) have experience with the conduct of such assessments 
over the phone and this minimizes perceived or real influence from the physician or team.  The 
University of Chicago collaborators and research staff, who are subcontracted through a PCORI 
contract with the University of Chicago, will be blinded to group assignment. The HCCQ will also 
be completed as part of the patient and caregiver packets in follow up time points for comparison. 
 
1.3.2. Press-Ganey Patient Satisfaction Survey (Follow-up): The Press Ganey patient satisfaction 
survey consists of a standardized set of questions that measure patient satisfaction in a given 
healthcare setting.  The survey also represents one of the most widely used methods in the 
ambulatory setting.  Additional questions may be added to the survey in order to assess unique 
services or performance improvement issues for a specific organization.  The Press Ganey survey 
has been utilized to assess patient-reported outcomes in satisfaction for research studies in a 
number of areas within healthcare, including emergency and cardiovascular medicine.15  Measures 
were selected from the Press Ganey survey for utilization in the current protocol to assess patient 
satisfaction with their oncology care related to their physician/healthcare provider, personal issues 
related to their care, experience with chemotherapy, and an overall assessment of their care.  
 
1.3.3. FACT:  Quality of life will be measured using the Functional Assessment of Chronic Illness 
Therapy tool.  Although there are several validated tools for QoL, the FACT has been validated in 
the geriatric population.16,17 It is a subset of a larger group of FACT scales that assess health-
 related  quality of life measures.  It has demonstrated high internal validity and high test-retest 
reliability.18  
1.3.4. Karnofsky Self-Reported Performance Status:  This one item question will assess impact of 
cancer and cancer symptoms on overall health.   
1.3.5. MD Anderson Symptom Inventory (MDASI):  Symptoms will be assessed using the MD-
Anderson symptom inventory (MDASI) tool.  This is a brief patient-reported measure assessing 
the impact of cancer-related symptoms.  This 19-question survey assesses 13 core symptom items 
found to have the highest frequency and/or severity in cancer patients.  It also includes items 
relating to symptom interference with daily life.  Studies have demonstrated good internal 
reliability.19   
1.3.6. Emotional Distress:  Different domains of emotional distress will be assessed.  The Distress 
Thermometer is widely used by health professionals to assess the level of patient distress (on a 0-
10 scale).20  Dr. Hurria found that 41% of older patients with cancer (n=245) report significant 
distress and found an association between higher distress (≥ 4) and poorer physical function, 
increased comorbid medical conditions, and poor eyesight.21  Perceived burdensomeness was 
assessed using one item from the Interpersonal Needs Questionnaire- Revised (INQ-R).22  
Okuyama et al.’s study of cancer patients’ reluctance to disclose their emotional distress to their 
physician assesses 4 domains of emotional distress: no perceived need, fear of negative impact, 
negative attitude, and hesitation using the instrument, Reluctance to Disclose Emotional Distress 
(RDED).23   
1.4. Communication and Decision-Making Preferences 
1.4.1. Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE)***24 evaluates the 
extent to which patients with advanced cancer have a sense of peaceful acceptance of their 
terminal illness. Evaluated in 160 patients with advanced cancer, the 12-item PEACE 

URCC13070 Protocol 2017-04-25 
    
Page 48 of 56 
questionnaire has 2 subscales: a 7-item Struggle With Illness subscale (Cronbach’s alpha = .81) 
and a 5-item Peaceful Acceptance subscale (alpha = 0.78). Both subscales were associated with 
patients' self-reported peacefulness (correlation coefficient [r] = 0.66 for acceptance [P <0.01]; r = 
-0.37 for struggle [P <0 .01]).  This measure has been adapted for use with caregivers through Dr. 
Epstein’s work. 
1.4.2.  The Perceived Efficacy in Patient-Physician Interactions (PEPPI) scale*** 25 measures 
patients’ and caregivers’ confidence in their ability to communicate their concerns, obtain and 
understand information, ask questions, clarify uncertainties, and make sure that their doctor 
understands them.   In older patients, a 5-item short form of the PEPPI demonstrated Cronbach's 
alphas of 0.83.  PEPPI demonstrated discriminant and convergent validity, correlating positively 
with active coping (r=0.17, P=0.03), and with patient satisfaction with physician interpersonal 
manner (r=0.49, P < 0.01) and communication (r=0.51, P < 0.01).  
1.4.3.  Control Preferences Scale***26 assesses whether patients and caregivers  would want an 
active, passive, or shared decision-making process with their doctors. This tool has been validated 
for use in advanced cancer patients, older patients, and caregivers.27,28   
1.4.4. MUIS-Complexity Subscale:29  Complexity is one of four validated subscales of the MUIS 
that addresses cues about treatment and system of care that are multiple and varied. 
2. CRA Packet (CRA fills out at visits) 
2.1. Tumor and Treatment Characteristics: The tumor stage, previous surgery or radiation, 
chemotherapy type, dosing, and schedule (intended and received), other cancer treatments, and 
supportive care medications will be captured by the CRA.  Survival status at 12 months from study 
entry will be captured on the withdrawal form or survival status form, once available.  
2.1.1. 
Cancer Treatment History will be used to collect the patient’s previous treatments for 
his/her advanced cancer. 
 
2.2. KPS Physician Rated:  The CRA will obtain the physician’s assessment of the impact of cancer 
and cancer treatment on the patient’s overall function.   
2.3. Geriatric Assessment 
2.3.1. 
 Timed Up and Go***:30  The Timed Up & Go is a performance based test of functional 
status, measuring how many seconds it takes to stand up from a standard arm-chair, walk 3 
meters (10 feet), turn, walk back to the chair, and sit down again. In community dwelling 
older adults, there was inter-rater and intra-rater reliability (intra-class correlation coefficient 
0.99 for both).  
2.3.2. 
Mini-Cog:  A tool that is validated in the geriatric population to quickly assess cognitive 
impairment.31,32 The Mini-Cog takes approximately 3 minutes to administer.  It has minimal 
language content, which reduces cultural and educational bias.  It combines a 3-item recall 
component with a Clock Drawing Test. 
2.3.3. 
 Short Blessed Orientation-Memory-Concentration (BOMC) Test ***:  A six-question 
evaluation that screens for cognitive impairment.  Studies have shown its validity as a 
screening instrument and the correlation of its results with those of more extensive mental 
status tests.33   
2.3.4. 
 Nutritional Status and Mini Nutrition Assessment (MNA):  Screening for nutritional 
deficit will be performed with body mass index (BMI) evaluation and self-reported weight 
loss.  Further nutritional evaluation will be performed with the Mini-Nutritional 

URCC13070 Protocol 2017-04-25 
    
Page 49 of 56 
Assessment*** (MNA)34, a well validated screening measure for nutritional deficiency which 
has shown to be prognostic of survival in older patients with cancer. Weight will be assessed 
at each time point.  Height will be measured at baseline. 
2.3.5. 
 Short Physical Performance Battery:35 Physical performance measures objectively 
evaluate mobility and fall risk. Falls are common in older cancer patients and predictive of 
adverse outcomes.  
2.3.6. 
Labs:  CRA will send results of baseline tests collected including hemoglobin, liver 
function tests, and renal function.   
2.3.7. 
Polypharmacy will be ascertained from the medical record after patients have been asked 
to review their medication list on file for any changes in the Polypharmacy Log and 
Polypharmacy High Risk Drug Review. 
 
3. Caregiver Packet  
3.1. Demographics***:  Age, race and ethnicity, gender, highest level of education achieved, 
employment status, marital status, and presence of a living companion will be captured.  
Additionally, we will collect information on underlying health conditions (Physical Health). 
3.2. Caregiver Reaction Assessment (CRA)36 is designed to measure the reactions of family members 
to caring for elderly relatives. The instrument consists of five dimensions (caregiver’s esteem, lack 
of family support, finances, schedule, and health).  Items are rated on a 5-point scale (from 
"strongly agree" to "strongly disagree").  The CRA allows for measurement of positive and 
negative reactions to caregiving. 
3.3. The 12-Item Short Form Health Survey (SF-12):37  This measure was developed for the Medical 
Outcomes Study (MOS), a multi-year study of patients with chronic conditions.  The measure 
assesses functional health and well-being. 
3.4. Cost of Care:38  Hanly et al. conducted a survey that identified indirect and directs costs associated 
with taking care of a cancer patient.   
3.5. Ryff measure of psychological well-being:39  The Ryff 6-construct assessment of well-being has 
been studied within numerous settings.  The environmental mastery subscale will be used to assess 
how well the caregiver perceives that he/she is managing responsibilities.   
3.6. Psychological well-being: The caregiver psychological wellbeing will be assessed with two 
measures, PHQ2 and GAD-7***. Caregiver’s perspective on patients’ psychological well-being 
will be captured with AD-8.40 
3.7. Caregivers will also complete 1.2.5., 1.3.1., 1.3.2., 1.3.6., and measures within 1.4.  
4. Physician Assessment  
4.1. Physician Baseline Demographics and Treatment Preferences***:  Age, race and ethnicity, 
gender, and details on medical practice will be captured. We will also capture patient volume, and 
specify years of training after fellowship. We will assess comfort with shared decision making in 
the baseline survey.  The goal of shared decision- making is to make decisions in a manner 
consistent with the patient's wishes. The patient drives the process. Determining where on the 
shared decision-making continuum the patient feels most comfortable requires clear 
communication and dedicated time from the physician.  Several studies have utilized the proposed 
measure for assessing the relationship of physician decision-making styles on clinical 
outcomes.28,41,42 

URCC13070 Protocol 2017-04-25 
    
Page 50 of 56 
4.2. Situational Vignettes***:  Physicians will be presented with one of eight clinical scenarios of an 
elderly cancer patient with a variety of geriatric-related impairments (i.e. physical frailty, cognitive 
impairment).  A series of questions will follow each vignette inquiring about the likelihood of the 
physician to offer chemotherapy in the scenario and details regarding the regimen that would be 
considered (i.e. chemotherapy type, dosing, etc.).   Only one vignette will be provided to each 
physician.  The survey will not be repeated with each subsequent patient. 
 Treatment Decision-Making Form (after each audiotaped visit):  Physicians will complete a short 
(<10 questions) follow-up survey requesting information on the treatment plan for the patient and 
factors that influenced how the decision was made.  This follow-up survey is adapted from work 
by Dr. Dale and Dr. Mohile evaluating how decisions are made for starting hormonal treatment for 
prostate cancer. Physicians will be asked to identify factors that influenced their decision in 
developing a treatment plan for each specific patient (i.e., age, stage of disease, performance 
status, geriatric measures).  Physicians will rank each factor to determine which are most 
influential in their decision making process.  Physicians will also be asked if results of geriatric 
assessment influenced their decision-making.  If physicians have multiple patients enrolled on 
study, this survey will be completed for each individual patient. 
 
4.3.  Physician Follow-up Survey (follow-up):  Physicians will complete a brief survey on REDCap, 
which will ask them about confidence in geriatrics and their opinion on the usefulness of the 
Geriatric Assessment (for intervention arm). Some questions asked at baseline will be repeated at 
study completion. 
4.4. Understanding of Disease-Physician a: Measures what the physician believes about the patient’s 
illness.  
5.  Audio-recordings of oncologist-patient visit 
A CRA will audio-record the patient-oncologist consultation. This visit must occur after the geriatric 
assessment is completed and before treatment initiation.  A medical consultation should be scheduled 
prior to start of cancer treatment (if planned).  We will assess the number of age-related concerns 
brought up by patients and caregivers.  We will also assess how the physician addresses these 
concerns.  Our team has experience with all of the study measures.  Transcriptionists will transcribe 
all audio-recorded visits and will be blinded to study condition.  Coders will undergo extensive 
training and supervision by developers of the scales. Transcriptionists and coders will not be part of the 
study team or involved in any other aspects of the study, and will be blinded to study hypotheses and 
site assignments to intervention or control.   Further, during analysis, study team members will be 
blinded to site assignments of intervention or control.  
 
 

URCC13070 Protocol 2017-04-25 
    
Page 51 of 56 
TABLES OF DATA TO BE KEPT 
 
Table 1: Patient Measures 
 
Measure 
Aim 
Screening 
Visit 00 
Baseline 
Visit 01 
Telephone 
Team 
Calla 
4-6 
Weeks 
Visit 02 
3 
Months 
Visit 03 
6 
Months 
Visit 04 
Demographics 
 
Pt 
 
 
 
 
 
ADL 
GA 
Pt 
 
 
Pt 
Pt 
Pt 
IADL 
GA 
Pt 
 
 
Pt 
Pt 
Pt 
Fall History 
GA 
Pt 
 
 
Pt (f/u) 
Pt (f/u) 
Pt (f/u) 
OARS Physical Health  
GA 
Pt 
 
 
Pt 
Pt 
Pt 
OARS Comorbidity 
GA 
Pt 
 
 
 
 
 
OARS Medical Social Support  
GA 
Pt 
 
 
 
 
 
Social Activities 
GA 
Pt 
 
 
Pt (1 item) 
Pt (1 item) 
Pt (1 item) 
GAD-7  
GA 
Pt 
 
 
 
 
 
GDS 
GA 
Pt 
 
 
Pt 
Pt 
Pt 
Patient-rated KPS 
S2 
Pt 
 
 
Pt 
Pt 
Pt 
HCCQ 
P1 
 
 
Pt 
Pt 
Pt 
Pt 
HCCQ-age 
P1 
 
 
Pt 
Pt 
Pt 
Pt 
Press-Ganey Pt Satisfaction 
P1 
 
 
 
Pt 
Pt 
Pt 
FACT 
S2 
 
Pt 
 
Pt 
Pt 
Pt 
MDASI 
S2 
 
Pt 
 
Pt 
Pt 
Pt 
Emotional Distress 
S2 
Pt 
 
 
Pt 
Pt 
Pt 
PEACE 
E 
 
Pt 
 
Pt 
 
 
PEPPI 
E 
 
Pt 
 
Pt 
 
 
Control Preferences Scale 
E 
 
Pt 
 
 
 
 
MUIS- Complexity Subscale 
E 
 
Pt 
 
Pt 
Pt 
Pt 
Understanding of Disease 
E 
 
Pt 
 
Pt 
 
 
Survey Completion 
 
Pt 
 
 
Pt 
Pt 
Pt 
 
Note: Screening and baseline can be combined.  a A research staff member from the Telephone Team will call the patient 
within 1 to 7 days after the baseline audiorecorded visit.  
 
Abbreviations: Pt (Patient); Phys (Physician); GA (Geriatric Assessment); P1 (Primary Aim 1); E (Exploratory Aim); S2 
(Secondary Aim 2); ADL (Activities of Daily Living); IADL (Instrumental Activities of Daily Living); GAD (Generalized 
Anxiety Disorder 7-Item Scale); Geriatric Depression Scale (GDS); KPS (Karnofsky Performance Status); PEACE (Peace, 
Equanimity, and Acceptance in the Cancer Experience); PEPPI (The Perceived Efficacy in Patient-Physician Interactions); 
MUIS (Mishel Uncertainty in Illness Scale); CTSQ (Cancer Treatment Satisfaction Questionnaire); FACTF (Functional 
Assessment of Chronic Illness Therapy); MDASI (MD Anderson Symptom Inventory). 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 52 of 56 
 
Table 2: Caregiver Measures  
Measure 
Aim 
Screening 
Visit 00 
Baseline 
Visit 01 
Telephone 
Team 
Calla 
4-6 
Weeks 
Visit 02 
3 
Months 
Visit 03 
6 
Months 
Visit 04 
Demographics 
 
C 
 
 
 
 
 
Caregiver Reaction  
S2 
C 
 
 
C 
C 
C 
OARS Comorbidity 
S2 
C 
 
 
 
 
 
SF-12 
S2 
 
C 
 
C (f/u) 
C (f/u) 
C (f/u) 
Cost of Care 
S2 
C 
 
 
C 
C 
C 
Ryff Environmental Mastery 
S2 
 
C 
 
C 
C 
C 
PHQ-2 
S2 
 
C 
 
C 
C 
C 
GAD-7 Anxiety 
S2 
 
C 
 
 
 
 
Health Care Climate Questionnaire-
Communication (caregiver) 
S3 
 
 
 
C 
C 
C 
HCCQ-age (patient) 
S3 
 
 
 
C 
C 
C 
HCCQ-age (general, caregiver) 
S3 
 
 
 
C 
C 
C 
Press-Ganey Pt Satisfaction 
S3 
 
 
 
C 
C 
C 
Distress Thermometer 
S2 
C 
 
 
C 
C 
C 
PEACE 
E 
 
C 
 
C 
 
 
PECPI 
E 
 
C 
 
C 
 
 
Control Preferences Scale 
E 
 
C 
 
 
 
 
MUIS- Complexity Subscale 
E 
 
C 
 
C 
C 
C 
Understanding of Disease 
E 
 
C 
 
C 
 
 
AD8 
E 
C 
 
 
C (f/u) 
C (f/u) 
C (f/u) 
 
Note: Screening and baseline can be combined.  a A research staff member from the Telephone Team will call the patient 
within 1 to 7 days after the baseline audiorecorded visit. 
 
Abbreviations: C (Caregiver); CRA (Clinical Research Associate); Pt (Patient); Phys (Physician); GA (geriatric assessment); 
P1 (Primary Aim 1); I (Intervention); E (Exploratory Aim); S1 (Secondary Aim 1); S2 (Secondary Aim 2); S3 (Secondary 
Aim 3); PEACE (Peace, Equanimity, and Acceptance in the Cancer Experience); PEPPI (The Perceived Efficacy in Patient-
Physician Interactions); MUIS (Mishel Uncertainty in Illness ScaleSF-12 (12-Item Short Form Health Survey); PHQ-2 (2-
Item Patient Health Questionnaire); GAD (Generalized Anxiety Disorder 7-Item Scale); HCCQ (Health Care Climate 
Questionnaire); KPS (Karnofsky Performance Status); Blessed OMC (Blessed-Orientation Memory Concentration Test); 
SPPB (Short Physical Performance Battery).  
 
 
 
 

URCC13070 Protocol 2017-04-25 
    
Page 53 of 56 
Table 3: Clinical Research Associate & Physician Measures 
 
Measures 
Aim 
Screening 
Visit 00 
Baseline 
Visit 01 
Telephone 
Team Calla 
4-6 Weeks 
Visit 02 
3 Months 
Visit 03 
6 Months 
Visit 04 
Audio-taped Pt-Phys Visit 
S1 
 
CRA 
 
 
 
 
Screening Coversheet page 2b 
 
CRA 
 
 
 
 
 
Tumor & Treatment Characteristics 
E 
CRA 
 
 
CRA 
(f/u) 
CRA 
(f/u) 
CRA (f/u) 
Cancer Treatment History Form 
S1 
 
CRA 
 
 
 
 
Physician rated KPS 
 
S2 
CRA 
 
 
CRA 
CRA 
CRA 
Lab Screening Form 
GA 
CRA 
 
 
 
 
 
Polypharmacy  
GA 
CRA 
 
 
 
 
 
Polypharmacy High Risk Drug Review 
GA 
CRA 
 
 
 
 
 
BOMC Test 
GA 
CRA 
 
 
 
 
 
Mini-Cog 
GA 
CRA 
 
 
CRA 
CRA 
CRA 
Nutritional Status and MNA 
GA 
CRA 
 
 
 
 
 
Timed “Up and Go” 
GA 
CRA 
 
 
 
 
 
Short Physical Performance Battery 
GA 
CRA 
 
 
CRA 
CRA 
CRA 
GA Scoring Guide to Detect Impairments 
GA 
CRA 
 
 
 
 
 
Physician Baseline Surveyc 
E 
Phys 
 
 
 
 
 
Situational Vignettesc 
E 
Phys 
 
 
 
 
 
Physician Follow-Up Surveyd 
E 
 
 
 
 
 
Physd 
Treatment Decision Making Form 
E 
 
Phys 
 
 
 
 
Understanding of Disease -Physician 
E 
 
Phys 
 
 
 
 
Study Related Formse  
 
 
 
 
 
 
 
Screening Log 
 
 
 
 
 
 
 
Patient Eligibility Screening Form 
 
 
 
 
 
 
 
Caregiver Eligibility Screening Form 
 
 
 
 
 
 
 
Patient Withdrawal Form 
 
 
 
 
 
 
 
Physician Withdrawal Form 
 
 
 
 
 
 
 
Caregiver Withdrawal Form 
 
 
 
 
 
 
 
Survival Status Formf 
 
 
 
 
 
 
 
URCC NCORP AE Report 
 
 
 
 
 
 
 
Note: Screening and baseline can be combined. The measures/forms are not listed in the order of administration.  a A research staff member from 
the Telephone Team will call the patient within 1 to 7 days after the baseline audiorecorded visit.  b The Screening Coversheet page 2 collects 
patient information that will be used to establish survival status. c The Physican Baseline Survey will be administered via REDCap or paper form 
and the situational vignettes are collected as  part of the Physician Baseline Survey.  d The physician follow-up survey will be administered at the 
end of the study period. e These forms will be used for study documentation purposes.  fCollected at one year. Abbreviations: C (Caregiver); CRA 
(Clinical Research Associate); Pt (Patient); Phys (Physician); GA (geriatric assessment); P1 (Primary Aim 1); I (Intervention); E (Exploratory 
Aim); S1 (Secondary Aim 1); S2 (Secondary Aim 2); S3 (Secondary Aim 3); KPS (Karnofsky Performance Status); Blessed OMC (Blessed-
Orientation Memory Concentration Test); SPPB (Short Physical Performance Battery),NCI: National Cancer Institute; URCC NCORP Research 
Base (University of Rochester Cancer Center NCI Community Oncology Research Program Research Base), AE (Adverse Event).  
 
 
 
MEASURES REFERENCES:  

URCC13070 Protocol 2017-04-25 
    
Page 54 of 56 
1. 
Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. The       
Gerontologist 1970;10:20-30. 
2. 
Hurria A, Gupta S, Zauderer M, et al. Developing a cancer-specific geriatric assessment: a 
feasibility study. Cancer 2005;104:1998-2005. 
3. 
Hurria A, Togawa K, Mohile SG, et al. Predicting chemotherapy toxicity in older adults with 
cancer: a prospective multicenter study. Journal of clinical oncology : official journal of the American 
Society of Clinical Oncology 2011;29:3457-65. 
4. 
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety 
disorder: the GAD-7. Archives of internal medicine 2006;166:1092-7. 
5. 
Parmelee PA, Katz IR. Geriatric depression scale. Journal of the American Geriatrics Society 
1990;38:1379. 
6. 
Adams KB, Matto HC, Sanders S. Confirmatory factor analysis of the geriatric depression scale. 
The Gerontologist 2004;44:818-26. 
7. 
Williams GC, Deci EL. The importance of supporting autonomy in medical education. Annals of 
internal medicine 1998;129:303-8. 
8. 
Williams GC, McGregor HA, Sharp D, et al. Testing a self-determination theory intervention for 
motivating tobacco cessation: supporting autonomy and competence in a clinical trial. Health 
psychology : official journal of the Division of Health Psychology, American Psychological Association 
2006;25:91-101. 
9. 
Vallerand RJ, O'Connor BP, Blais MR. Life satisfaction of elderly individuals in regular community 
housing, in low-cost community housing, and high and low self-determination nursing homes. 
International journal of aging & human development 1989;28:277-83. 
10. 
Zafar SY, Malin JL, Grambow SC, et al. Chemotherapy use and patient treatment preferences in 
advanced colorectal cancer: a prospective cohort study. Cancer 2013;119:854-62. 
11. 
Safran DG, Karp M, Coltin K, et al. Measuring patients' experiences with individual primary care 
physicians. Results of a statewide demonstration project. Journal of general internal medicine 
2006;21:13-21. 
12. 
Press Ganey: public reporting gives huge boost to patient satisfaction. Healthcare benchmarks 
and quality improvement 2008;15:121-3. 
13. 
Cowan P. Press Ganey scores and patient satisfaction in the emergency department (ED): the 
patient perspective. Pain medicine 2013;14:969. 
14. 
Zusman EE. HCAHPS replaces Press Ganey survey as quality measure for patient hospital 
experience. Neurosurgery 2012;71:N21-4. 
15. 
Glickman SW, Boulding W, Manary M, et al. Patient satisfaction and its relationship with clinical 
quality and inpatient mortality in acute myocardial infarction. Circulation Cardiovascular quality and 
outcomes 2010;3:188-95. 
16. 
Webster K, Cella D, Yost K. The Functional Assessment of Chronic Illness Therapy (FACIT) 
Measurement System: properties, applications, and interpretation. Health and quality of life outcomes 
2003;1:79. 
17. 
Avlund K, Pedersen AN, Schroll M. Functional decline from age 80 to 85: influence of preceding 
changes in tiredness in daily activities. Psychosomatic medicine 2003;65:771-7. 
18. 
Chandran V, Bhella S, Schentag C, Gladman DD. Functional assessment of chronic illness therapy-
fatigue scale is valid in patients with psoriatic arthritis. Annals of the rheumatic diseases 2007;66:936-9. 
19. 
Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer patients: the 
M.D. Anderson Symptom Inventory. Cancer 2000;89:1634-46. 
20. 
Ransom S, Jacobsen PB, Booth-Jones M. Validation of the Distress Thermometer with bone 
marrow transplant patients. Psycho-oncology 2006;15:604-12. 

URCC13070 Protocol 2017-04-25 
    
Page 55 of 56 
21. 
Hurria A, Li D, Hansen K, et al. Distress in older patients with cancer. Journal of clinical oncology : 
official journal of the American Society of Clinical Oncology 2009;27:4346-51. 
22. 
Van Orden KA, Witte TK, Gordon KH, Bender TW, Joiner Jr TE. Suicidal desire and the capability 
for suicide: Tests of the interpersonal-psychological theory of suicidal behavior among adults. Journal of 
consulting and clinical psychology 2008;76:72-83. 
23. 
Okuyama T, Endo C, Seto T, et al. Cancer patients' reluctance to disclose their emotional distress 
to their physicians: a study of Japanese patients with lung cancer. Psycho-oncology 2008;17:460-5. 
24. 
Mack JW, Nilsson M, Balboni T, et al. Peace, Equanimity, and Acceptance in the Cancer 
Experience (PEACE): validation of a scale to assess acceptance and struggle with terminal illness. Cancer 
2008;112:2509-17. 
25. 
Maly RC, Frank JC, Marshall GN, DiMatteo MR, Reuben DB. Perceived efficacy in patient-
physician interactions (PEPPI): validation of an instrument in older persons. Journal of the American 
Geriatrics Society 1998;46:889-94. 
26. 
Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. The Canadian journal of 
nursing research = Revue canadienne de recherche en sciences infirmieres 1997;29:21-43. 
27. 
Singh JA, Sloan JA, Atherton PJ, et al. Preferred roles in treatment decision making among 
patients with cancer: a pooled analysis of studies using the Control Preferences Scale. The American 
journal of managed care 2010;16:688-96. 
28. 
Elkin EB, Kim SH, Casper ES, Kissane DW, Schrag D. Desire for information and involvement in 
treatment decisions: elderly cancer patients' preferences and their physicians' perceptions. Journal of 
clinical oncology : official journal of the American Society of Clinical Oncology 2007;25:5275-80. 
29. 
Mishel MH. The measurement of uncertainty in illness. Nursing research 1981;30:258-63. 
30. 
Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail 
elderly persons. Journal of the American Geriatrics Society 1991;39:142-8. 
31. 
Borson S, Scanlan JM, Chen P, Ganguli M. The Mini-Cog as a screen for dementia: validation in a 
population-based sample. Journal of the American Geriatrics Society 2003;51:1451-4. 
32. 
Costa D, Severo M, Fraga S, Barros H. Mini-Cog and Mini-Mental State Examination: agreement 
in a cross-sectional study with an elderly sample. Dementia and geriatric cognitive disorders 
2012;33:118-24. 
33. 
Katzman R, Brown T, Fuld P, Peck A, Schechter R, Schimmel H. Validation of a short Orientation-
Memory-Concentration Test of cognitive impairment. The American journal of psychiatry 1983;140:734-
9. 
34. 
Zulian GB, Gold G, Herrmann F, Michel JP. Mini Nutritional Assessment and cancer. Nestle 
Nutrition workshop series Clinical & performance programme 1999;1:93-8, 9-100. 
35. 
Guralnik JM, Ferrucci L, Simonsick EM, Salive ME, Wallace RB. Lower-extremity function in 
persons over the age of 70 years as a predictor of subsequent disability. The New England journal of 
medicine 1995;332:556-61. 
36. 
Given CW, Given B, Stommel M, Collins C, King S, Franklin S. The caregiver reaction assessment 
(CRA) for caregivers to persons with chronic physical and mental impairments. Research in nursing & 
health 1992;15:271-83. 
37. 
Jakobsson U. Using the 12-item Short Form health survey (SF-12) to measure quality of life 
among older people. Aging clinical and experimental research 2007;19:457-64. 
38. 
Hanly P, Ceilleachair AO, Skally M, et al. How much does it cost to care for survivors of colorectal 
cancer? Caregiver's time, travel and out-of-pocket costs. Supportive care in cancer : official journal of 
the Multinational Association of Supportive Care in Cancer 2013;21:2583-92. 
39. 
Ryff CD, Keyes CL. The structure of psychological well-being revisited. Journal of personality and 
social psychology 1995;69:719-27. 

URCC13070 Protocol 2017-04-25 
    
Page 56 of 56 
40. 
Galvin JE, Roe CM, Xiong C, Morris JC. Validity and reliability of the AD8 informant interview in 
dementia. Neurology 2006;67:1942-8. 
41. 
Arora NK, Weaver KE, Clayman ML, Oakley-Girvan I, Potosky AL. Physicians' decision-making 
style and psychosocial outcomes among cancer survivors. Patient education and counseling 
2009;77:404-12. 
42. 
Epstein RM, Street RL, Jr. Shared mind: communication, decision making, and autonomy in 
serious illness. Annals of family medicine 2011;9:454-61.