Improving Surgical Care and Outcomes in Older Cancer Patients Through Implementation of an Efficient Pre-Surgical Toolkit (OPTI-Surg)
Phase: NA
Conditions: Malignant Neoplasm, Surgical Procedure, Unspecified, Health Care Provider, Carcinoma
Sponsor: Alliance for Clinical Trials in Oncology

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ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY 
ALLIANCE A231601CD 
IMPROVING 
SURGICAL 
CARE 
AND 
OUTCOMES 
IN OLDER 
CANCER PATIENTS THROUGH 
IMPLEMENTATION OF AN EFFICIENT PRE-SURGICAL TOOLKIT (OPTI-SURG) 
ClinicalTrials.gov Identifier: NCT03857620 
Study Chair and 
Alliance Cancer Care Delivery Committee Chair 
 
 
 
 
 
 
 
Community Oncology Co-chair 
Study Co-chair 
Cancer in the Elderly Co-Chair 
 
 
 
 
 
 
 
 
Modality Co-chair 
Modality Co-chair 
 
  
 
 
 
 
Primary Statistician 
Secondary Statistician 
 
 
 
 
 
 
Data Manager 
Protocol Coordinator 
 
 
 
  
 
 
Institutions participating in this study will be randomized to one of three arms. This protocol provides 
general information for all participating practices.  In order to maintain institutional blinding, information 
specific to the intervention (OPTI Surg) arms is provided separately in Appendices III-VII.  Practices will 
receive the appendices specific to the arm to which they are randomized following randomization. 
Participants: NCORP components of the Alliance (lead), ECOG-ACRIN, NRG, and SWOG NCORP Research 
Bases

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Study Resources: 
Expedited Adverse Event Reporting 
 
 Medidata Rave iMedidata portal 
 
OPEN (Oncology Patient Enrollment Network) 
 
 Biospecimen Management System 
 
Protocol Contacts: 
A231601CD Nursing Contact 
 
 
Protocol-related questions may be directed as follows: 
Questions 
Contact (via email) 
Questions regarding patient eligibility, treatment, 
and dose modification: 
Study Chair, Nursing Contact, Protocol 
Coordinator, and (where applicable) Data 
Manager 
Questions related to data submission, RAVE or 
patient follow-up: 
Data Manager 
Questions regarding the protocol document and 
model informed consent: 
Protocol Coordinator 
Questions related to IRB review 
Alliance Regulatory Inbox 
 
Questions regarding CTEP-AERS reporting: 
Alliance Pharmacovigilance Inbox 
 

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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments: 
For data submission: 
Regulatory documentation must 
be submitted to the CTSU via 
the Regulatory Submission 
Portal. 
 (Sign in at 
and 
select the Regulatory > 
Regulatory Submission.)  
Institutions with patients 
waiting that are unable to use 
the Portal should alert the 
CTSU Regulatory Office 
immediately at 
 
to receive further instruction 
and support. 
Contact the CTSU Regulatory 
Help Desk at 
 
for regulatory assistance. 
Refer to the patient enrollment 
section of the protocol for 
instructions on using the 
Oncology Patient Enrollment 
Network (OPEN). OPEN is 
accessed at 
  
Contact the CTSU Help Desk 
with any OPEN related questions 
by phone or email : 
  
Data collection for this study 
will be done exclusively through 
Medidata Rave. Refer to the data 
submission section of the 
protocol for further instructions.  
The most current version of the study protocol and all supporting documents must be downloaded 
from the protocol-specific page located on the CTSU members’ website 
 Access 
to the CTSU members’ website is managed through the Cancer Therapy and Evaluation Program - 
Identity and Access Management (CTEP-IAM) registration system and requires log in with a CTEP-
IAM username and password.  
Permission to view and download this protocol and its supporting documents is restricted and is based 
on person and site roster assignment housed in the CTSU Regulatory Support System (RSS).   
For clinical questions (i.e. patient eligibility or treatment-related) see the Protocol Contacts, Page 2. 
For non-clinical questions (i.e. unrelated to patient eligibility, treatment, or clinical data 
submission) 
Contact the CTSU Help Desk by phone or e-mail:  
CTSU General Information Line – 
 All calls and 
correspondence will be triaged to the appropriate CTSU representative.  

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IMPROVING SURGICAL CARE AND OUTCOMES IN OLDER CANCER PATIENTS THROUGH 
IMPLEMENTATION OF AN EFFICIENT PRE-SURGICAL TOOLKIT (OPTI-SURG) 
Patient Eligibility Criteria: (See Section 3.1)
Required Initial Lab Values
•
Patients must have known or suspected cancer diagnosis and have
None
one of the following cancer-directed operations planned: Gastrectomy; Colectomy; Proctectomy; Esophagectomy; 
Pancreatectomy; Hepatectomy; Total cystectomy; Partial or Total Nephrectomy; Lung resection (wedge resection, 
segmentectomy, lobectomy, or pneumonectomy) 
•
Age ≥ 70 years
•
Patients with known metastatic disease with a plan for curative intent resection are eligible.
•
Patients with double primaries undergoing planned curative operation for both are eligible.
•
Patients undergoing emergent surgery are not eligible.
•
Patients under active treatment for second primary are not eligible.
•
Patients with known metastatic disease who are undergoing palliative resection are not eligible.
•
Patients with psychiatric illness or other mental impairment that would preclude their ability to give
informed consent or to participate in the prehabilitation program are not eligible.
•
Patients must be able to speak and complete questionnaires in English.
Institutional Randomization:
ARM 1
Usual Care
30 surgical practices 
RANDOMIZED
ARM 2
OPTI-Surg Group 1 
No Coach
ARM 3
OPTI-Surg Group 2 
with Coach
Patient Schema:
Group 1
Usual Care
Usual Care
Register
Group 2 
OPTI-Surg 
OPTI-Surg
Pre-surgical intervention
Surgery
Group 3
OPTI-Surg plus Coach
OPTI-Surg
Pre-surgical intervention
Sample size is about 15 (target 15, maximum 25) consented patients per each of 30 surgical practices (450 
consented patients). 
Consented patients will complete the CHAMPS and EQ-5D questionnaires at baseline and 8 weeks post-
surgery. 
NOTE: Practice-level data will be collected for all eligible patients (including those not registered to the 
trial) until the site has completed accrual, study procedures and data collection of consenting patients. 
Surgical complications will be assessed for all eligible patients at 8 and 12 weeks after surgery.  
See Sections 7.1 and 4.3.1 for institutional participation requirements.

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TABLE OF CONTENTS 
1.0 
BACKGROUND ............................................................................................................................. 7 
1.1 
Introduction ................................................................................................................................... 7 
1.2 
Current state of knowledge and clinical/care delivery practice .................................................... 7 
1.3 
Preliminary Data ........................................................................................................................... 8 
1.4 
Contribution to cancer care delivery ............................................................................................. 8 
1.5 
Study design .................................................................................................................................. 9 
1.6 
Goals ........................................................................................................................................... 10 
2.0 
OBJECTIVES ............................................................................................................................... 12 
2.1 
Primary objective ........................................................................................................................ 12 
2.2 
Secondary objectives .................................................................................................................. 12 
2.3 
Exploratory objectives ................................................................................................................ 12 
3.0 
PATIENT SELECTION............................................................................................................... 13 
3.1 
Eligibility Criteria ....................................................................................................................... 13 
4.0 
PATIENT REGISTRATION ....................................................................................................... 14 
4.1 
Investigator and Research Associate Registration with CTEP ................................................... 14 
4.2 
Cancer Trials Support Unit Registration Procedures .................................................................. 15 
4.3 
Institutional randomization and arm-specific protocols .............................................................. 17 
4.4 
Patient Registration Requirements .............................................................................................. 18 
4.5 
Patient Registration/Randomization Procedures ......................................................................... 18 
4.6 
Stratification (or Grouping) Factors and Treatment Assignments .............................................. 19 
5.0 
STUDY CALENDAR ................................................................................................................... 20 
5.1 
Patient-level Study Calendar ....................................................................................................... 20 
5.2 
Site-level Study Calendar............................................................................................................ 21 
6.0 
DATA SUBMISSION ................................................................................................................... 21 
6.1 
Data Collection and Submission ................................................................................................. 21 
7.0 
STUDY IMPLEMENTATION .................................................................................................... 24 
7.1 
Eligible Practices ........................................................................................................................ 24 
7.2 
OPTI-Surg Toolkit ...................................................................................................................... 24 
7.3 
Institutional training .................................................................................................................... 24 
7.4 
Randomization ............................................................................................................................ 24 
7.5 
Site/Practice implementation ...................................................................................................... 25 
8.0 
STUDY INTERVENTION ........................................................................................................... 26 
8.1 
Electronic Medical Review (EMR) ............................................................................................. 26 
8.2 
Frailty assessment ....................................................................................................................... 26 
8.3 
Patient consent and registration .................................................................................................. 26 
8.4 
Baseline questionnaire administration and pre-surgical interventions ........................................ 26 
8.5 
Surgery and Follow-up (all sites) ................................................................................................ 27 
9.0 
ADVERSE EVENTS .................................................................................................................... 27 
9.1 
Routine Adverse Event Reporting .............................................................................................. 27 
9.2 
CTCAE Routine Reporting Requirements .................................................................................. 27 

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9.3 
Expedited Adverse Event Reporting (CTEP-AERS) .................................................................. 28 
10.0 
MEASURES .................................................................................................................................. 31 
10.1 
Definitions of endpoints .............................................................................................................. 31 
10.2 
Schedule of evaluations .............................................................................................................. 31 
10.3 
Practice-level reported measures ................................................................................................ 32 
10.4 
Patient-reported measures ........................................................................................................... 37 
11.0 
END OF INTERVENTION ......................................................................................................... 37 
11.1 
Duration of Intervention.............................................................................................................. 37 
11.2 
Follow-up .................................................................................................................................... 37 
11.3 
Managing ineligible patients and registered patients who never receive protocol intervention . 37 
12.0 
STATISTICAL CONSIDERATIONS ........................................................................................ 38 
12.1 
Statistical design ......................................................................................................................... 38 
12.2 
Endpoints .................................................................................................................................... 38 
12.3 
Power and sample size ................................................................................................................ 39 
12.4 
Analysis plan ............................................................................................................................... 40 
12.5 
Study Monitoring ........................................................................................................................ 42 
12.6 
Inclusion of Women and Minorities ........................................................................................... 43 
13.0 
GENERAL REGULATORY CONSIDERATIONS: WAIVERS OF CONSENT & 
REMOTE INFORMED CONSENT ....................................................................................................... 44 
13.1 
Waivers of documentation of patient consent ............................................................................. 44 
13.2 
Waivers of documentation of healthcare provider consent ......................................................... 44 
13.3 
Potential benefits of the proposed research to human subjects and others ................................. 46 
13.4 
Importance of the knowledge to be gained ................................................................................. 46 
13.5 
Remote Informed Consent .......................................................................................................... 46 
14.0 
REFERENCES .............................................................................................................................. 47 
15.0 
MODEL CONSENT FORM ........................................................................................................ 50 
APPENDIX I 
CHAMPS AND EQ-5D-5L QUESTIONNAIRES ...................................................... 59 
APPENDIX II 
ORCA SURVEY ....................................................................................................... 74 
APPENDIX III 
ADDITIONAL INFORMATION FOR PRACTICES RANDOMIZED TO ARM 
2 (OPTI-SURG ONLY) ............................................................................................................................ 81 
APPENDIX IV 
EDMONTON FRAIL SCALE (ARMS 2 AND 3) .................................................. 90 
APPENDIX V 
EDMONTON FRAIL SCALE – ACUTE CARE (EFS-AC) (ARMS 2 AND 3) .. 91 
APPENDIX VI 
EDMONTON FRAIL SCALE – BEDSIDE VERSION ........................................ 93 
APPENDIX VII 
ACCEPTABILITY OF INTERVENTION MEASURE (AIM), 
INTERVENTION APPROPRIATENESS MEASURE (IAM), AND FEASIBILITY OF 
INTERVENTION MEASURE (FIM) (ARMS 2 AND 3) ...................................................................... 95 
APPENDIX VIII  HEALTHCARE PROVIDER INFORMATION SHEET (ARMS 2 AND 3) .... 97 
APPENDIX IX 
 TELEPHONE SCRIPT INTRODUCING OPTI-SURG (ARMS 2 AND 3) ....... 98 
APPENDIX X 
ADDITIONAL INFORMATION FOR PRACTICES RANDOMIZED TO ARM 
3 (OPTI-SURG PLUS COACH) .............................................................................................................. 99 

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1.0 
BACKGROUND 
1.1 
Introduction 
The number of older adults who undergo major surgery is expected to double from 7 million to 
14 million by 2030.1 Frailty, an age-related decline in physiologic reserve, is present in least 
half of older adults who undergo elective surgery.2-4 There is strong evidence that components 
of frailty–functional and cognitive impairment, malnutrition, depression, and social 
vulnerability–put patients at risk for complications, mortality, prolonged length of stay, 
discharge to an institution and not home, functional decline, and poor quality of life.3-10 
Mounting evidence indicates that multimodal interventions aimed at optimizing vulnerabilities 
associated with frailty before surgery result in decreased complications, enhanced functional 
recovery, increased discharge to home, reduced length of stay, and decreased hospital cost.11-14 
Recently published best practices guidelines for the optimal care of the geriatric surgical patient 
released by the American Geriatrics Society and the American College of Surgeons state that 
these vulnerabilities should be identified and optimized preoperatively.15 In current surgical 
practice, however, routine screening for or attempt to address these vulnerabilities before 
surgery is not performed. Screening tools are perceived to be cumbersome and primary surgical 
providers are not equipped to directly address the uncovered vulnerabilities. The goal of the 
proposed study is to evaluate the implementation of an efficient tool in surgical practices that 
can detect and optimize the components of frailty before surgery. 
1.2 
Current state of knowledge and clinical/care delivery practice 
Well-coordinated perioperative and practice-based interventions can improve older patients’ 
functional status after surgery but few surgical practices have implemented these strategies. A 
recent survey of surgical oncologists reported that although the majority of surgeons expressed 
interest in preoperative optimization for older patients, only 6% of them currently perform 
geriatric assessments in their older patients.16 Factors contributing to the low level of adoption 
include perceptions regarding the amount of time required to assess for vulnerabilities and lack 
of specific programs designed to address them within typical surgical oncology practices. This 
project focuses on implementing an efficient tailored tool to determine the potential for a 
package toolkit that identifies and addresses geriatric vulnerabilities preoperatively to affect the 
delivery of surgical cancer care to elderly frail patients. Moreover, we will determine which 
practice-change strategies effectively integrate these interventions into routine delivery. Practice 
facilitation and quality improvement methods have been shown to be effective in improving 
implementation of guidelines and evidence based practices (EBP).17 Practice facilitation has 
been defined as “a process of interactive problem solving and support that occurs in a context 
of a recognized need for improvement and a supportive interpersonal relationship.”31 Within 
practice facilitation, quality improvement methods are used to facilitate the implementation of 
the new EBP, such as the plan-do-study-act (PDSA) cycles from the Institute for Healthcare 
Improvement model. For practice facilitation, we will use a centralized implementation coach 
to assist practices to implement the pre-surgical optimization intervention. Prior research also 
shows that tailoring interventions to account for variance in practice culture can improve 
intervention uptake and effectiveness. Our study design thus focuses not only on assessing the 
effectiveness of an efficient tool on improving outcomes for patients, but also on assessing the 
cultural climate in which practice facilitation and care delivery improvement efforts are 
deployed. 
Frailty and surgical outcomes in cancer patients: Frailty is common in older adults presenting 
for surgery. Emerging data indicates that frailty, compared to advanced age alone, is more 
strongly associated with morbidity and mortality after surgery.6-8 Although published studies 

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often use different instruments to measure frailty, the overwhelming majority of studies have 
found that frailty is associated with complications, early and late mortality, prolonged length of 
stay, poor functional recovery, discharge to an institution, and lower quality of life.3-10 Cancer 
surgery among frail older adults is associated with a 3 to 4-fold increase in both 30-day post-
operative complications and mortality.7,10 An analysis of SEER-Medicare showed an 11 item 
frailty measure was associated with a 10-fold increase in 90-day mortality following colorectal 
surgery.8  
Evidence supports multimodal optimization to improve functional outcomes before major 
surgery:  Studies evaluating preoperative optimization of a single domain of vulnerability (e.g., 
nutrition or fitness) have had mixed results.14 However, multimodal interventions that address 
multiple vulnerabilities have demonstrated impressive results.12,13  In a study of elderly patients 
undergoing colorectal surgery, 81% of older patients who were enrolled in a trimodal 
prehabilitation program, including protein supplementation, anxiety reduction, and an exercise 
program, had returned to baseline function at 8 weeks compared with only 40% in the pre-
intervention control group.13 In another before-and-after study of the effect of pre-operative 
comprehensive geriatric assessment and multimodal prehabilitation education (home exercise, 
nutrition, relaxation techniques, and pain management), outcomes were significantly improved 
among patients who underwent the intervention (pneumonia, 4% post-intervention period vs 
20% pre-intervention period; delirium, 6% post-intervention period vs 19% pre-intervention 
period; and length of stay, 12 days post-intervention period vs 16 days pre-intervention 
period).12 A recent single center study of older patients undergoing thoracic and abdominal 
surgery demonstrated that preoperative program consisting of exercise, nutritional 
supplementation, and stress management education significantly reduces hospital costs and 
length of stay.30 Multimodal interventions aimed at modifying frailty traits are likely to yield the 
most benefit in older patients. 
1.3 
Preliminary Data 
Our group at the UCSF Center for Surgery in Older Adults developed a program to identify and 
optimize frail patients prior to major surgery. Pilot implementation of the Edmonton Frail Scale 
(EFS) in our clinic showed that it required the following administration time: by first-year 
medical students mean 10.1/median 9.5 minutes, range 6-16 minutes. During the pilot phase, 
our team which includes a surgeon, geriatrician, occupational therapist, physical therapist, and 
dietician, developed and refined written materials and resource guides to support optimization 
of frailty before surgery. Materials were developed in an iterative approach incorporating 
feedback from a patient and family advisory panel and older surgical patients preparing for 
surgery.  
For practices randomized to Arm 2, see also, Appendix III; for practices randomized to Arm 3, 
see also Appendix X. 
1.4 
Contribution to cancer care delivery 
Major surgery in frail older adults often results in complications, death, functional decline, loss 
of independence, affecting quality of life and causing significant resource burdens to patients, 
families, and health care systems. Older adults with limited life-expectancy often value function 
and independence over potential gains in life-expectancy.19 Surgical care pathways that assess 
and attempt to optimize frailty traits before surgery will enhance functional recovery for frail 
cancer patients and ensure that frail adults who undergo major cancer surgery achieve their 
treatment goals and maintain independence. To implement frailty screening and optimization 
into diverse surgical practices, a robust study is needed that tests an efficient screening and 
optimization tool and addresses clinical culture and barriers to implementation in a broad variety 

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of clinical settings. If feasible and effective on the practice level, the OPTI-Surg toolkit will 
improve the delivery of cancer surgery and quality of life for frail older adults in the U.S. 
This study will inform care and improve outcomes for frail older adults who undergo major 
cancer surgery. If successful, this study will demonstrate that implementation of frailty 
screening is feasible in a busy clinic setting, acceptable to clinic staff, and that practice-based 
implementation of OPTI-Surg improves functional recovery in frail older adults and reduces 
post-operative morbidity. Furthermore, this trial has the potential for broad impact for cancer 
care delivery by serving as a model for testing and implementing practice-based interventions 
aimed at improving surgical outcomes not only among frail older adults but for patients with a 
variety of conditions. 
1.5 
Study design 
We plan a cluster randomized trial to evaluate the effectiveness of practice-level implementation 
of OPTI-Surg. Practices will be randomized to the OPTI-Surg package intervention alone, 
OPTI-Surg with an implementation coach, or usual care. Interventions at the practice level are 
most likely to result in standardized approaches to patient evaluation and management with the 
highest likelihood of successful broad-based implementation. Randomization by practice will 
also prevent contamination. The comparison of coach versus no-coach arms will provide data 
on which practice change strategies are effective while ensuring that strategies are feasible and 
acceptable. Through this study design, we will both evaluate the effectiveness of the OPTI-Surg 
intervention to improve surgical outcomes at the patient level, but we will also gain further 
insight on the effectiveness of implementing this intervention at the practice level. We will gain 
knowledge about the implementation process as practices implement the OPTI-Surg Toolkit in 
order to better understand how practice level interventions should be conducted. Our design also 
includes direct measurement of practice culture and intervention roll-out through mixed 
methods (surveys, observation, and qualitative interviews). These mixed-methods data will 
identify barriers to implementation and acceptability, inform continuous improvement of the 
intervention, and provide insights into how to tailor the intervention to individual practice sites 
to ensure effective dissemination. 
Study population: The target of intervention will be surgical practices. The study will include 
evaluation of patients, providers, and practice organizational and structural factors. Practices 
will be randomized to utilize the OPTI-Surg package intervention alone, OPTI-Surg with an 
implementation coach, or usual care. Eligible practices will be engaged in elective cancer 
operations that are high risk in older adults. Based on administrative data on operative mortality, 
the following have been identified as high risk in older adults: Gastrectomy 3-10%; colectomy 
1-2%; proctectomy 2%; esophagectomy 6-16%; pancreatectomy 2-10%; hepatectomy 3-7%; 
nephrecetomy 2%; total cystectomy 3%; and lung lobectomy/pneumonectomy 3-9%.19 Eligible 
practices will have a high prevalence of patients among whom there is a high risk of frailty and 
be categorized as either a thoracic, major abdominal, or urologic practice. Prior research has 
shown that > 50% of patients aged 70+ presenting for major surgery are frail.6 Based on this 
data, patients included in the study will be (a) age ≥ 70 years who are presenting for surgical 
evaluation for (b) one of the noted high risk procedures (listed above). To address the variation 
in expected functional recovery by procedure type, we plan to stratify randomization by three 
practice types: (1) thoracic, (2) major abdominal, and (3) urologic. Esophagogastric procedures 
may be included in either the thoracic or major abdominal surgery categories, depending upon 
the specialty of the operating surgeon. 
Endpoints: This study will incorporate both patient-level and site-level data collection.  For 
patient-level data collection, individual eligible patients will be approached for participation and 

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will sign a consent form for completion of questionnaires preoperatively—at baseline prior to 
surgery or optimization intervention—and at 8 weeks after surgery.  
For site-level data collection, data collection will consist of chart review and will include all 
eligible patients within the practice during the duration of the study.  The primary study endpoint 
(patient-level data) is the function level 8 weeks after surgery. Physical function will be 
measured preoperatively at baseline and 8 weeks after surgery using the Community Healthy 
Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS includes 41 
questions that ask the senior to estimate the time spent on a range of activities. Among older 
adults with limited life-expectancy, function and independence are highly valued. A major goal 
of preoperative optimization of frailty traits is to improve baseline function and mitigate social 
vulnerability so that functional recovery is accelerated after surgery. The secondary endpoints 
(site-level data) are post-operative morbidity (grade I or higher surgical complications) and 
penetration of OPTI-Surg administration (i.e., screening rate among eligible patients) in the 
OPTI-Surg alone and OPTI-Surg plus coaching arms. Proctor and colleagues defined 
penetration as the “integration of a practice within a service setting and its subsystems.”21 
Penetration will be calculated as the number of older adults administered the OPTI-Surg, divided 
by the total number of older adults eligible for OPTI-Surg.  
1.6 
Goals 
The goal of this study is to improve the delivery of surgical cancer care in OPTI-Surg to identify 
vulnerabilities and promote targeted interventions to improve outcomes. This cluster-
randomized trial will assess the effectiveness of the OPTI-Surg package within the NCORP 
community oncology research programs. The primary goal is to improve 8-week postoperative 
function among elderly patients through incorporation of a practice level targeted pre-surgical 
geriatric intervention. 8-week post-operative function will be compared between the combined 
OPTI-Surg arms versus the usual care arm. We hypothesize that among surgical practices that 
employ the frailty assessment and intervention, patient-reported function 8 weeks after surgery 
will be higher than the usual care sites. 
Secondary goals are to assess the potential of the OPTI-Surg toolkit to decrease postoperative 
morbidity. We hypothesize that among surgical practices that employ the OPTI-Surg 
intervention, a lower proportion of patients will experience postoperative complications. We 
also seek to assess and compare the penetration of the OPTI-Surg within surgical practices 
between arms with and without an implementation coach. We will assess practice level rates of 
completion of the brief assessment for all older surgical patients and compare them between 
sites randomize to either no coach or coach. 
We also hope to learn about how practice level changes can be implemented to impact global 
outcomes in the real-world setting. We will: 
1) Assess the impact of the OPTI-Surg toolkit on postoperative mortality, length of hospital 
stay, discharge to a facility, and hospital readmission. Mortality, length of hospital stay, 
discharge to a facility, and hospital readmissions will be compared between the combined 
OPTI-Surg arms versus the usual care arm. 
2) Assess subsequent referral for the indicated optimization intervention and assess practice-
level structural factors associated with penetration of the OPTI-Surg package. We 
hypothesize that OPTI-Surg implementation rates will vary depending on the available 
resources and capacity and the presence or absence of stakeholder buy-in, but that it can 
be influenced by the presence of an implementation coach. 

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3) Explore the acceptability, feasibility, and appropriateness of the intervention (Section 10) 
[More information for institutions randomized to OPTI-Surg arms is provided in 
Appendices III and X.].  
4) Document and assess barriers and facilitators to implementation through mixed-methods 
research. To facilitate interpretation of the trial results and to facilitate future dissemination 
and implementation, we propose to use mixed-methods (qualitative and quantitative) to 
collect and analyze data. To collect quantitative data, we will use a validated survey, the 
Organizational Readiness to Change Assessment (ORCA), to assess practice readiness and 
identify potential barriers or challenges.22  
Qualitative data will be collected during site visits with selected study sites. These in-depth 
ethnographic case studies will occur at a total of 12 Alliance sites – 2 usual care sites, 5 sites 
with the OPTI-Surg intervention only, and 5 sites that have the OPTI-Surg intervention plus the 
coach. The site visit will include observation of everyday clinic processes and interviews with 
clinic leaders, staff, and front-line workers. Site visits will be conducted before, during, and after 
the implementation of the OPTI-Surg intervention in order to examine barriers and facilitators 
to implementing the intervention. Specifically, we will plan site visits at the 12 case-study sites 
at the following three points in time: 1) a baseline site visit will occur before the OPTI-Surg 
intervention has been introduced at the site; 2) an in-progress site visit will occur after OPTI-
Surg intervention has been implemented and while it is still active; we will schedule this visit 
after the 5th patient has been recruited and ensure that the site visit occurs before enrollment at 
the site is complete; 3) a post-intervention visit will occur 6-9 months after the final (15th ) 
patient has been recruited at the study site; this visit will assess what, if any, lasting impact 
OPTI-Surg appears to have had on practice culture and routines at the site. 
 
 

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2.0 
OBJECTIVES 
2.1 
Primary objective 
To compare 8-week postoperative function among elderly patients between sites randomized to 
implement the OPTI-Surg toolkit with or without a coach versus sites randomized to usual care. 
2.2 
Secondary objectives 
2.2.1 To compare postoperative morbidity between sites randomized to implement the OPTI-
Surg toolkit with or without a coach versus sites randomized to usual care. 
2.2.2 To compare the penetration of the OPTI-Surg toolkit between sites randomized to 
implement the OPTI-Surg toolkit with a coach versus sites randomized to implement the 
OPTI-Surg toolkit without a coach. 
2.3 
Exploratory objectives 
2.3.1 To compare postoperative mortality, hospital length of stay, discharge to a facility, and 
hospital readmission between sites randomized to implement the OPTI-Surg toolkit with 
or without a coach versus sites randomized to usual care. 
2.3.2 To assess subsequent initiation and follow through of appropriate referral for the indicated 
optimization intervention and assess practice-level structural factors associated with 
uptake of the OPTI-Surg package. 
2.3.3 To document and assess barriers and facilitators to implementation and dissemination 
through mixed-methods research. 
 
 

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3.0 
PATIENT SELECTION 
For questions regarding eligibility criteria, see the Study Resources page. Please note that the Study 
Chair cannot grant waivers to eligibility requirements.  
3.1 
Eligibility Criteria 
___ 
3.1.1 
Eligible patients must have known or suspected cancer diagnosis and have 
one of the following cancer-directed operations planned:  
• 
Gastrectomy  
• 
Colectomy 
• 
Proctectomy  
• 
Esophagectomy 
• 
Pancreatectomy  
• 
Hepatectomy  
• 
Total cystectomy  
• 
Partial or Total Nephrectomy 
• 
Lung resection (wedge resection, segmentectomy, lobectomy, or pneumonectomy)  
___ 
3.1.2 
Age ≥ 70 years 
___ 
3.1.3 
Patients with known metastatic disease with a plan for curative intent 
resection are eligible (e.g., curative liver resection for metastatic colorectal cancer). 
___ 
3.1.4 
Patients with double primaries undergoing planned curative operation for 
both are eligible (e.g., synchronous colon cancers undergoing colectomy to treat both). 
___ 
3.1.5 
Patients undergoing emergent surgery are not eligible. 
___ 
3.1.6 
Patients under active treatment such as chemotherapy, targeted therapy, 
immunotherapy, radiation treatment, etc. for second primary, are not eligible. 
However, patients not currently receiving treatment are eligible, including patients who 
have been previously treated for another cancer. Patients are not considered to have a 
“currently active” malignancy if they have completed therapy and are free of disease for ≥ 
2 years. 
___ 
3.1.7 
Patients with known metastatic disease who are undergoing palliative 
resection are not eligible. 
___ 
3.1.8 
Patients with psychiatric illness or other mental impairment that would 
preclude their ability to give informed consent or to participate in the prehabilitation 
program are not eligible. 
___ 
3.1.9 
Patients must be able to speak and complete questionnaires in English. 
 
 

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4.0 
PATIENT REGISTRATION 
4.1 
Investigator and Research Associate Registration with CTEP 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy 
require all individuals contributing to NCI-sponsored trials to register and renew their 
registration annually. To register, all individuals must obtain a Cancer Therapy Evaluation 
Program 
(CTEP) 
Identity 
and 
Access 
Management 
(IAM) 
account 
at 
In addition, persons with a registration type of Investigator 
(IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) must complete their annual 
registration using CTEP’s web-based Registration and Credential Repository (RCR) at 
  
RCR utilizes five person registration types. 
• 
IVR — MD, DO, or international equivalent; 
• 
NPIVR — advanced practice providers (e.g., NP or PA) or graduate level researchers 
(e.g., PhD); 
• 
AP — clinical site staff (e.g., RN or CRA) with data entry access to CTSU applications 
such as the Roster Update Management System [RUMS], OPEN, Rave, acting as a 
primary site contact, or with consenting privileges; 
• 
Associate (A) — other clinical site staff involved in the conduct of NCI-sponsored trials; 
and 
• 
Associate Basic (AB) — individuals (e.g., pharmaceutical company employees) with 
limited access to NCI-supported systems. 
 
RCR requires the following registration documents: 
Documentation Required 
IVR NPIVR AP 
A 
AB 
FDA Form 1572 
✔ 
✔ 
 
 
 
Financial Disclosure Form 
✔ 
✔ 
✔ 
 
 
NCI Biosketch (education, training, employment, license, and 
certification) 
✔ 
✔ 
✔ 
GCP training 
✔ 
✔ 
✔ 
Agent Shipment Form (if applicable) 
✔ 
CV (optional) 
✔ 
✔ 
✔ 
 
An active CTEP-IAM user account and appropriate RCR registration is required to access all 
CTEP and Cancer Trials Support Unit (CTSU) websites and applications. In addition, IVRs and 
NPIVRs must list all clinical practice sites and Institutional Review Boards (IRBs) covering 
their practice sites on the FDA Form 1572 in RCR to allow the following: 
• 
Addition to a site roster;  
• 
Assign the treating, credit, consenting, or drug shipment (IVR only) tasks in OPEN; 
• 
Act as the site-protocol Principal Investigator (PI) on the IRB approval; and  
• 
Assign the Clinical Investigator (CI) role on the Delegation of Tasks Log (DTL).  

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In addition, all investigators acting as the Site-Protocol PI (investigator listed on the IRB 
approval), consenting/treating/drug shipment investigator in OPEN, or as the CI on the DTL 
must be rostered at the enrolling site with a participating organization.  
Additional 
information 
is 
located 
on 
the 
CTEP 
website 
at 
For questions, please contact the 
RCR Help Desk by email at 
  
4.2 
Cancer Trials Support Unit Registration Procedures 
Permission to view and download this protocol and its supporting documents is restricted and is 
based on person and site roster assignment housed in the CTSU Regulatory Support System 
(RSS). 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
IRB Approval:   
For CTEP and Division of Cancer Prevention (DCP) studies open to the National Clinical Trials 
Network (NCTN) and NCI Community Oncology Research Program (NCORP) Research Bases 
after March 1, 2019, all U.S.-based sites must be members of the NCI Central Institutional 
Review Board (NCI CIRB). In addition, U.S.-based sites must accept the NCI CIRB review to 
activate new studies at the site after March 1, 2019. Local IRB review will continue to be 
accepted for studies that are not reviewed by the CIRB, or if the study was previously open at 
the site under the local IRB. International sites should continue to submit Research Ethics Board 
(REB) approval to the CTSU Regulatory Office following country-specific regulations.  
Sites participating with the NCI CIRB must submit the Study Specific Worksheet for Local 
Context (SSW) to the CIRB using IRBManager to indicate their intent to open the study locally. 
The NCI CIRB’s approval of the SSW is automatically communicated to the CTSU Regulatory 
Office, 
but 
sites 
are 
required 
to 
contact 
the 
CTSU 
Regulatory 
Office 
at 
to establish site preferences for applying NCI CIRB approvals 
across their Signatory Network. Site preferences can be set at the network or protocol level. 
Questions about establishing site preferences can be addressed to the CTSU Regulatory Office 
by email or calling 
 
In addition, the Site-Protocol Principal Investigator (PI) (i.e. the investigator on the IRB/REB 
approval) must meet the following criteria in order for the processing of the IRB/REB approval 
record to be completed: 
• 
Holds an active CTEP status; 
• 
Rostered at the site on the IRB/REB approval (applies to US and Canadian sites only) 
and on at least one participating roster; 
• 
If using NCI CIRB, rostered on the NCI CIRB Signatory record; 
• 
Includes the IRB number of the IRB providing approval in the Form FDA 1572 in the 
RCR profile; and 
• 
Holds the appropriate CTEP registration type for the protocol.  
Additional Requirements 
Additional requirements to obtain an approved site registration status include: 
• 
An active Federal Wide Assurance (FWA) number; 

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• 
An active roster affiliation with the Lead Protocol Organization (LPO) or a Participating 
Organization (PO); and  
• 
Compliance with all protocol-specific requirements (PSRs). 
4.2.1 Protocol-Specific Requirements for A231601CD Site Registration  
• 
Institutional Approval Document (see Section 4.3.1) 
• 
Practice Level Data Collection Form – The enrolling affiliate/sub affiliate will 
complete the NCORP Practice Level Data Collection Form and submit it to the 
CTSU Regulatory Office using the Regulatory Submission Portal located in the 
Regulatory section of the CTSU website. The form will collect various attributes 
about the enrolling affiliate/sub affiliate. All of the questions on the form must be 
complete and the distribution for the analytic cases question must equal 100%. 
(See form for directions.) The form must be received and complete for site 
registration approval in RSS. The Practice Level Data Collection Form 
requirement is submitted once for participation on all NCORP Cancer Care 
Delivery (CCDR) trials, but will expire two years after it is received. NCORP sites 
will need to resubmit the Practice Level Data Form to the CTSU in order to 
continue to enroll to CCDR trials. 
4.2.2 Downloading site registration documents 
Download the site registration forms from the protocol-specific page located on the CTSU 
members’ website. Permission to view and download this protocol and its supporting 
documents is restricted based on person and site roster assignment. To participate, the 
institution and its associated investigators and staff must be associated with the LPO or a 
Protocol Organization (PO) on the protocol. One way to search for a protocol is listed 
below. 
• 
Log in to the CTSU members’ website 
using your CTEP-
IAM username and password; 
• 
Click on Protocols in the upper left of the screen 
o Enter the protocol number in the search field at the top of the protocol tree; 
or 
o Click on the By Lead Organization folder to expand, then select Alliance, 
and protocol number A231601CD. 
• 
Click on Documents, select Site Registration, and download and complete the 
forms provided.  
(Note: For sites under the CIRB, IRB data will load automatically to the CTSU.) 
4.2.3 Submitting Regulatory Requirements  
Submit required forms and documents to the CTSU Regulatory Office using the Regulatory 
Submission Portal on the CTSU website.  
To access the Regulatory Submission Portal log in to the CTSU members’ website, go to 
the Regulatory section and select Regulatory Submission. 
Institutions with patients waiting that are unable to use the Regulatory Submission Portal 
should alert the CTSU Regulatory Office immediately at 
 in order to 
receive further instruction and support. 

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4.2.4 Checking Site’s Registration Status  
Site registration status may be verified on the CTSU members’ website. 
• 
Click on Regulatory at the top of the screen; 
• 
Click on Site Registration; and 
• 
Enter the site’s 5-character CTEP Institution Code and click on Go. 
o Additional filters are available to sort by Protocol, Registration Status, 
Protocol Status, and/or IRB Type. 
 
Note: The status shown only reflects institutional compliance with site registration 
requirements as outlined within the protocol. It does not reflect compliance with protocol 
requirements for individuals participating on the protocol or the enrolling investigator’s 
status with NCI or their affiliated networks. 
4.3 
Institutional randomization and arm-specific protocols 
4.3.1 Institutional Registration 
Institutions that are interested in participating in this study must contact the study Project 
Manager, 
 for site approval procedures: 
 
 
 
 
 
 
 
 
Sites should complete the information required in the Institutional Approval Document 
posted along with Supplementary materials on the Alliance and CTSU websites, and send 
it to 
 at the email address listed above. The document will ask for the 
following information: Name of the site, CTEP Site Code, CTEP Site Code of Main 
NCORP and contact information (Full name and email) of site staff who will complete the 
site/practice survey in Medidata Rave.  
To approve the site for participation, the project manager will return this document to the 
institution with a signature of approval. As soon as the site receives IRB approval, it must 
submit this Institutional Approval Document to the Alliance Registration Office via fax 
or email at 
The registration office will register the 
site to the study and send confirmation to the site via email within 1 business day, in order 
to be invited to enter site level data in Medidata Rave. The study will not use OPEN for 
site/practice enrollment. The contact person listed on the Institutional Approval Document 
will be sent an invitation to enter site level data in Medidata Rave.  
Additionally, the site will also submit this document to the CTSU Regulatory portal (see 
Section 4.2.3) in order to begin patient enrollment.  
4.3.2 Randomization will be stratified by practice type (thoracic, major abdominal, and 
urologic). 
The Alliance Statistics and Data Management Center will randomize surgical practices once 
an institution is interested and eligible to participate. All participants enrolled at a site will 
receive the intervention to which the treating institution is randomized. 
Institutions will be randomized to one of three intervention arms:  

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1) Usual Care 
2) OPTI-Surg without coach 
3) OPTI-Surg with coach 
4.3.3 Intervention-specific appendices 
In order to maintain institutional blinding with respect to OPTI-Surg interventions, 
information specific to the OPTI Surg arms is provided separately in Appendices III and 
X. 
Following 
randomization, 
practices 
should 
contact 
 
 
to obtain the appendices specific to the intervention arm to which 
the practice has been randomized. The OPTI-Surg Toolkit/Manual will also be provided to 
sites at this time. 
4.4 
Patient Registration Requirements 
Informed consent: The patient must be aware of the neoplastic nature of his/her disease and 
willingly consent after being informed of the procedure to be followed, the experimental nature 
of the intervention, alternatives, potential benefits, side-effects, risks, and discomforts. Current 
human protection committee approval of this protocol and a consent form is required prior to 
patient consent and registration. 
Patient completed booklets: Patient questionnaire booklets are to be ordered prior to the 
registration of any patients. Patient completed booklets can be ordered by downloading and 
completing the CTSU supply request form, located on the CTSU Forms webpage under the 
Resources tab. The form must be submitted via the Regulatory Submission Portal on the CTSU 
website, located under the Regulatory tab. Samples of the booklets are found in Appendix I, 
which are to be used for reference and IRB submission only. They are not to be used for patient 
completion. 
4.5 
Patient Registration/Randomization Procedures 
The Oncology Patient Enrollment Network (OPEN) is a web-based registration system available 
on a 24/7 basis. OPEN is integrated with CTSU regulatory and roster data and with the LPOs 
registration/randomization systems or the Theradex Interactive Web Response System (IWRS) 
for retrieval of patient registration/randomization assignment. OPEN will populate the patient 
enrollment data in NCI’s clinical data management system, Medidata Rave. 
Requirements for OPEN access: 
• 
A valid CTEP-IAM account; 
• 
To perform enrollments or request slot reservations: Must be on an LPO roster, ETCTN 
corresponding roster, or participating organization roster with the role of Registrar. 
Registrars must hold a minimum of an Associate Plus (AP) registration type; 
• 
If a Delegation of Tasks Log (DTL) is required for the study, the registrars must hold 
the OPEN Registrar task on the DTL for the site; and 
• 
Have an approved site registration for the protocol prior to patient enrollment. 
To assign an Investigator (IVR) or Non-Physician Investigator (NPIVR) as the treating, 
crediting, consenting, drug shipment (IVR only), or receiving investigator for a patient transfer 
in OPEN, the IVR or NPIVR must list the IRB number used on the site’s IRB approval on their 
Form FDA 1572 in RCR. If a DTL is required for the study, the IVR or NPIVR must be assigned 
the appropriate OPEN-related tasks on the DTL. 

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Prior to accessing OPEN, site staff should verify the following: 
• 
Patient has met all eligibility criteria within the protocol stated timeframes; and 
• 
All patients have signed an appropriate consent form and HIPAA authorization form (if 
applicable).  
Note:  The OPEN system will provide the site with a printable confirmation of registration and 
treatment information. You may print this confirmation for your records.  
Access OPEN at 
or from the OPEN link on the CTSU members’ website. 
Further instructional information is in the OPEN section of the CTSU website at 
For any additional questions, contact the CTSU 
  
4.6 
Stratification (or Grouping) Factors and Treatment Assignments 
Site randomization will be stratified by practice type: 
• 
Thoracic vs.  
• 
Major abdominal vs.  
• 
Urologic 
 
Patients will be grouped by site randomized arm: 
• 
Arm 1: Usual Care  
• 
Arm 2: OPTI-Surg without coach 
• 
Arm 3: OPTI-Surg with coach 
 
 

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5.0 
STUDY CALENDAR 
The pre-study testing intervals are guidelines only. Laboratory and clinical parameters during 
treatment are to be followed using individual institutional guidelines and the best clinical judgment 
of the responsible physician. It is expected that patients on this study will be cared for by physicians 
experienced in the treatment and supportive care of patients on this trial.  
Pre-Study Testing Intervals  
To be completed ≤ 28 DAYS before registration: History and physical. 
5.1 
Patient-level Study Calendar 
[Patient-level study calendars for practices randomized to Arms 2 and 3 are provided are Appendices III and X.] 
 
Screening 
Baseline* 
Day of 
Surgery 
8 weeks 
following 
surgery 
12 weeks 
following 
surgery 
 
Collected for all eligible (screened) patients 
Postoperative complications 
and outcomes 
 
 
 
X (1) 
X (1) 
Adverse Event Assessment 
 
 
X (1) 
 
 
 
Administered to all consenting patients 
Laboratory Studies 
 
 
 
 
 
HgB, WBC, Platelets 
 
X 
 
X*** 
 
Serum creatinine 
 
X 
 
X*** 
 
Serum albumin 
 
X 
 
X*** 
 
Tests & Observations** 
 
 
 
 
 
ECOG PS 
 
X 
 
X*** 
 
CHAMPS and EQ-5D Qx 
 
X 
 
X*** 
 
* 
At initial surgical consultation. Questionnaires may be completed at any time following consent, before 
or after registration. Additionally, sites may leverage satellite NCORP locations to obtain baseline and 
8-week follow-up labs and forms. 
** Site staff may contact participants via email, U.S. mail, telephone and/or telehealth to  
administer and obtain questionnaires and assessments, including the CHAMPS Survey  
and the ECOG Performance Score. 
*** Post surgery visits can be +/- 7 days 
1. For the purposes of collecting and reporting adverse events into the Alliance database using Rave 
“adverse events” are those potentially resulting from intervention occurring between baseline and 
surgery. “Surgical complications” will be assessed 8 and 12 weeks after surgery using the Clavien-Dindo 
Classification. All CTEP-AERS events should be reported as outlined in Section 9.0. 

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5.2 
Site-level Study Calendar 
[Site level study calendars for practices randomized to Arms 2 and 3 are provided in Appendices III and X.] 
 
Baseline* 
Monthly 
After 5th patient is enrolled 
and 6 to 9 mos. after last 
patient is enrolled 
6, 12 and 24 
months 
Demographic and structural data 
X 
 
 
 
Organizational Readiness to 
Change Assessment (ORCA) 
X 
 
 
X 
Ethnographic interviews and 
observations 
X (1) 
 
X (1) 
 
Listing of eligible patients 
 
X 
 
 
Postoperative Complications  
Administered per patient schedule and submitted monthly (3) 
* 
Following local IRB approval/activation of the study. 
1. To be administered to staff at 5 sites randomized to each intervention arm. 
3. Clavien Dindo Classification for grading severity of complications and American College of Surgeons’ 
National Quality Improvement Program geriatric outcome variables (Section 10.3.1).  To be collected 
for all eligible patients (including those who do not consent to completing the CHAMPS and EQ-5D 
questionnaires).  
6.0 
DATA SUBMISSION 
6.1 
Data Collection and Submission 
Medidata Rave is a clinical data management system being used for data collection for this 
trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role 
assignments. 
Requirements to access Rave via iMedidata: 
• 
A valid CTEP-IAM account; and  
• 
Assigned a Rave role on the LPO or PO roster at the enrolling site of: Rave CRA, Rave 
Read Only, Rave CRA (LabAdmin), Rave SLA, or Rave Investigator. 
Rave role requirements: 
o Rave CRA or Rave CRA (Lab Admin) role must have a minimum of an 
Associate Plus (AP) registration type; 
o Rave Investigator role must be registered as an Non-Physician Investigator 
(NPIVR) or Investigator (IVR); and 
o Rave Read Only role must have at a minimum an Associates (A) registration 
type.  
Refer to 
for registration types and 
documentation required. 
Upon initial site registration approval for the study in Regulatory Support System (RSS), all 
persons with Rave roles assigned on the appropriate roster will be sent a study invitation e-mail 
from iMedidata. To accept the invitation, site staff must log in to the Select Login 
using their CTEP-IAM username and password and 
click on the accept link in the upper right-corner of the iMedidata page. Site staff will not be 

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able to access the study in Rave until all required Medidata and study specific trainings are 
completed. Trainings will be in the form of electronic learnings (eLearnings) and can be 
accessed by clicking on the link in the upper right pane of the iMedidata screen. If an eLearning 
is required and has not yet been taken, the link to the eLearning will appear under the study 
name in iMedidata instead of the Rave EDC link; once the successful completion of the 
eLearning has been recorded, access to the study in Rave will be granted, and a Rave EDC link 
will display under the study name.  
Site staff that have not previously activated their iMedidata/Rave account at the time of initial 
site registration approval for the study in RSS will receive a separate invitation from iMedidata 
to activate their account. Account activation instructions are located on the CTSU website in the 
Data Management section under the Rave resource materials (Medidata Account Activation and 
Study Invitation Acceptance). Additional information on iMedidata/Rave is available on the 
CTSU members’ website in the Data Management > Rave section at 
or 
by contacting the CTSU Help Desk at 
  
A Schedule of Forms is available on the Alliance study webpage, within the Case Report Forms 
section. The Schedule of Forms is also available on the CTSU site within the study-specific 
Education and Promotion folder, and is named Time & Events. 
Patient-completed questionnaire booklets for this study are to be ordered prior to the 
registration of any patients (see Section 4.4). Samples of questionnaire booklets are available in 
Appendix I for reference and IRB submission only. They are not to be used for patient 
completion. Booklets must be given to patients to complete and patients should be instructed to 
return the booklets to site staff either in person or by mail and site staff will enter patient and 
caregiver responses into Rave.  
6.1.1 Data Quality Portal 
The Data Quality Portal (DQP) provides a central location for site staff to manage 
unanswered queries and form delinquencies, monitor data quality and timeliness, generate 
reports, and review metrics. 
The DQP is located on the CTSU members’ website under Data Management. The Rave 
Home section displays a table providing summary counts of Total Delinquencies and Total 
Queries. DQP Queries, DQP Delinquent Forms and the DQP Reports modules are available 
to access details and reports of unanswered queries, delinquent forms, and timeliness 
reports. Review the DQP modules on a regular basis to manage specified queries and 
delinquent forms. 
The DQP is accessible by site staff that are rostered to a site and have access to the CTSU 
website. Staff that have Rave study access can access the Rave study data using a direct 
link on the DQP. 
To learn more about DQP use and access, click on the Help icon displayed on the Rave 
Home, DQP Queries, and DQP Delinquent Forms modules. 
Note: Some Rave protocols may not have delinquent form details or reports specified on 
the DQP. A protocol must have the Calendar functionality implemented in Rave by the 
Lead Protocol Organization for delinquent form details and reports to be available on the 
DQP. Site staff should contact the LPO Data Manager for their protocol regarding 
questions about Rave Calendaring functionality. 

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6.1.2 Supporting Documentation to be Submitted to the Alliance 
This study requires supporting documentation for diagnosis and treatment of the cancer 
that is the target of the planned surgery. Supporting documentation will include: 
• 
Preoperative imaging reports (CT, MRI, PET/CT).   
• 
Operative reports.  
• 
Surgical pathology reports. 
Supporting documentation is to be submitted via Rave. Note: The pre-operative imaging is 
to be submitted within 12 weeks after registration. 
6.1.3 Practice level data 
Demographic and Structural Data: At baseline, the study team will collect basic 
practice-related demographic information and details regarding the organizational structure 
and resource availability (e.g., practice volume; payer mix; solo, single specialty, or multi-
specialty group practice; availability of geriatric specialists, palliative care providers, 
advanced practice providers, patient navigators, on site occupational and physical therapy, 
social workers, pharmacists, dietetics, integrative medicine). 
Qualitative Data: The team will collect qualitative data to document practice-level 
barriers and facilitators to OPTI-Surg implementation from 12 practices: 5 each from the 
two OPTI-Surg arms and 2 practices from the usual care arm.  In-person site visits to collect 
qualitative data will take place at the following time points:  Baseline (prior to the 
introduction of the OPTI-Surg intervention); after the fifth patient has been enrolled at the 
practice; and 6 to 9 months after the last patient has been enrolled at the practice. 
Qualitative data will be collected via direct observation of clinic processes and key-
informant interviews with practice leadership and with front-line staff. 
 
 

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7.0 
STUDY IMPLEMENTATION 
7.1 
Eligible Practices 
Eligible practices will be engaged in elective cancer operations that are high risk in older adults. 
Based on administrative data on operative mortality, the following have been identified as high 
risk in older adults: gastrectomy 3-10%; colectomy 1-2%; proctectomy 2%; esophagectomy 6-
16%; pancreatectomy 2-10%; hepatectomy 3-7%; nephrectomy 2%; total cystectomy 3%; and 
lung lobectomy/pneumonectomy 3-9%. 
Eligible practices will have a high prevalence (at least 10 cases per year) of patients among 
whom there is a high risk of frailty (age ≥70 years old) and be categorized as either a thoracic, 
major abdominal, or urologic practice. Practices should identify a clinical research professional, 
allied health professional, or equivalent to implement OPTI-Surg. 
Eligible practices should provide a brief description of any existing programs for frailty 
assessment and intervention. If their current practice includes the assessment and interventions 
specified in the protocol, they will be ineligible. 
See Section 4.3.1 for information regarding site approval procedures. 
7.2 
OPTI-Surg Toolkit 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, see 
Appendix X. 
7.3 
Institutional training 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, see 
Appendix X. 
7.4 
Randomization 
Randomization will be stratified by practice type (thoracic, major abdominal, and urologic). 
Pocock-Simon dynamic allocation with a 5% level of randomness (to ensure that the algorithm 
is not deterministic) added to the algorithm such that practices will be assigned to the arm in a 
1:1:1 fashion that leads to more imbalance 5% of the time.  Site randomization will be centrally 
performed by the Alliance Statistical and Data Center once an institution is interested and 
eligible to participate (see Section 4.3). 
 
 

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7.5 
Site/Practice implementation 
For institutions randomized to Arm 2 see Appendix III; for institutions randomized to Arm 3, 
see Appendix X. 
Usual Care  
 
Training 
Study overview and procedures 
 
Site Level Data 
(Baseline) 
Demographic and structural data 
Staff interviews 
ORCA 
 
For each patient: 
 
 Adverse Event Assessment 
Surgical complications & 
outcomes 
For consenting patients: 
Lab Studies 
CHAMPS & EQ-5D 
 
Site-Level Data 
(Monthly) 
Listing of eligible patients 
 
Site-Level Data 
(6, 12, and 24 months) 
ORCA 
(After 5th and 6 to 9 months 
after last patient is enrolled)** 
Staff interviews 
** Only to be done at 2 practices randomized to the Usual Care arm. 
7.5.1 Usual Care 
These practices will not get the OPTI-Surg intervention. Practices randomized to usual care 
will complete the practice demographic and structural survey and the ORCA questionnaire 
at baseline (i.e., as soon as the practice site agree to participate and before training) and at 
6, 12, and 24 months following site activation. Two practices randomized to usual care will 
also undergo staff interviews at baseline, after the fifth patient is enrolled, and 6 to 9 months 
after the last patient is enrolled to the study at the practice. 
For all patients (consented and unconsented) aged ≥ 70 years, practices will keep a log of 
all patients seen. The practice will submit the log monthly. In addition, the practices will 
submit data abstracted from patient charts. Practices will report surgical complications for 
all eligible patients. The log will be a spreadsheet format of the case report form variables. 
The CHAMPS and EQ-5D-5L questionnaires will be administered to consenting eligible 
patients at the time of the initial surgical consultation and 8 weeks after surgery.  

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7.5.2 OPTI-Surg without Coach 
For institutions randomized to Arm 2.  See Appendix III. 
7.5.3 OPTI-Surg with Coach 
For institutions randomized to Arm 3.  See Appendix X. 
8.0 
STUDY INTERVENTION 
[Additional information for practices randomized to Arm 2 or Arm 3 can be found in Appendix III 
and Appendix X, respectively.] 
The patient-level intervention will involve identification of eligible patients utilizing medical record 
review at all participating institutions.  
After patient registration to the study, the CHAMPS and EQ-5D-5L questionnaires will be 
administered. Patients will then proceed to surgery.  The follow-up CHAMPS and EQ-5D-5L 
questionnaires will be administered 8 weeks after surgery. 
All eligible patients (including those not consented to the study) will be assessed for surgical 
complications 8 and 12 weeks after surgery.  
8.1 
Electronic Medical Review (EMR) 
[Additional information for practices randomized to Arm 2 or Arm 3 can be found in Appendix 
III and Appendix X, respectively.] 
All eligible patients at all participating institutions will be identified using EMR monthly and as 
needed to screen patients for participation. Eligibility of all patients whether consenting to 
participate in the questionnaire portion of the study or not will be determined. Surgical 
complications will also be recorded for all patients. 
8.2 
Frailty assessment 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3.  See 
Appendix X. 
8.3 
Patient consent and registration 
All eligible patients at all participating practices should then be asked to participate in the 
questionnaire portion of this study, and if willing, consented. 
8.4 
Baseline questionnaire administration and pre-surgical interventions 
8.4.1 Baseline questionnaires (all practices) 
Following patient consent to the study (before or after registration), patients will be asked 
to complete the CHAMPS and questionnaire and the EQ-5D-5L.  
8.4.2 Pre-surgical intervention—Practices randomized to usual care arm 
Patients treated at practices randomized to usual care will undergo pre-operative 
management for surgery per usual institutional practices. 

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8.4.3 Pre-surgical intervention—Practices randomized to OPTI-Surg arms 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, 
see Appendix X. 
8.5 
Surgery and Follow-up (all sites) 
Surgery will be performed per the treating physician. 
For all patients, adverse events occurring from the patient’s initial evaluation to surgery will be 
collected. In addition, surgical complications will be assessed 8 and 12 weeks after surgery. 
For registered patients only, the questionnaires (CHAMPS and EQ-5D-5L) will be 
administered at 8 weeks. 
9.0 
ADVERSE EVENTS 
The prompt reporting of adverse events is the responsibility of each investigator engaged in clinical 
research, as required by Federal Regulations. Adverse events must be described and graded using the 
terminology and grading categories defined in the NCI’s Common Terminology Criteria for Adverse 
Events 
(CTCAE), 
Version 
5.0. 
The 
CTCAE 
is 
available 
at 
 
Attribution 
to 
protocol 
treatment for each adverse event must be determined by the investigator and reported on the required 
forms. Please refer the NCI Guidelines: Adverse Event Reporting Requirements for further details 
on AE reporting procedures.  
9.1 
Routine Adverse Event Reporting 
Adverse event data collection and reporting, which are required as part of every clinical trial are 
done to ensure the safety of patients enrolled in the studies as well as those who will enroll in 
future studies using similar agents. Adverse events are reported in a routine manner at scheduled 
times according to the study calendar in Section 5.0. For this trial, “Adverse Event: Other” form 
is to be used for routine AE reporting in Rave. 
9.2 
CTCAE Routine Reporting Requirements 
In addition to the solicited adverse events listed in Section 9.1, the following table outlines the 
combinations of time points, grades and attributions of AEs that require routine reporting to the 
Alliance Statistics and Data Center. Questions about routine reporting should be directed to the 
Data Manager. 
Combinations of CTCAE Grade & Attribution Required for Routine AE Data Submission on 
Case Report Forms (CRFs) 
Attribution 
Grade 1 
Grade 2 
Grade 3 
Grade 4 
Grade 5 
Unrelated 
 
 
a 
a 
a 
Unlikely 
 
 
a 
a 
a 
Possible 
 
a 
a, b 
a, b 
a, b 
Probable 
 
a 
a, b 
a, b 
a, b 
Definite 
 
a 
a, b 
a, b 
a, b 
a) Adverse Events: Other CRF - Applies to AEs occurring between registration and within 30 
days of the patient’s last treatment date, or as part of the Clinical Follow-Up Phase. 

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b) Adverse Events: Late CRF - Applies to AEs occurring greater than 30 days after the 
patient’s last treatment date. 
9.3 
Expedited Adverse Event Reporting (CTEP-AERS) 
Investigators are required by Federal Regulations to report serious adverse events as defined in 
the table below. Alliance investigators are required to notify the Alliance Central Protocol 
Operations Program, the Study Chair, and their Institutional Review Board if a patient has a 
reportable serious adverse event. The descriptions and grading scales found in the NCI Common 
Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.  
The 
CTCAE 
is 
identified 
and 
located 
on 
the 
CTEP 
website 
at: 
 
All 
appropriate 
treatment areas should have access to a copy of the CTCAE. All reactions determined to be 
“reportable” in an expedited manner must be reported using the Cancer Therapy Evaluation 
Program Adverse Event Reporting System (CTEP-AERS). 
For further information on the NCI requirements for SAE reporting, please refer to the ‘NCI 
Guidelines for Investigators: Adverse Event Reporting Requirements’ document published by 
the NCI.  
Note:  All deaths on study require both routine and expedited reporting regardless of causality.  
Attribution to treatment or other cause should be provided. 
 
 

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9.3.1 Expedited Reporting Requirements for Adverse Events that Occur in a Non-
IND/IDE trial ≤ 30 Days of the Last Administration  
FDA REPORTING REQUIREMENTS FOR SERIOUS ADVERSE EVENTS (21 CFR Part 312) 
NOTE:  Investigators MUST immediately report to the sponsor (NCI) ANY Serious Adverse Events, 
whether or not they are considered related to the investigational agent(s)/intervention (21 CFR 
312.64) 
 An adverse event is considered serious if it results in ANY of the following outcomes:   
1) Death 
2) A life-threatening adverse event  
3) An adverse event that results in inpatient hospitalization or prolongation of existing hospitalization 
for ≥ 24 hours  
4) A persistent or significant incapacity or substantial disruption of the ability to conduct normal life 
functions  
5) A congenital anomaly/birth defect.  
6) Important Medical Events (IME) that may not result in death, be life threatening, or require 
hospitalization may be considered serious when, based upon medical judgment, they may jeopardize 
the patient or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition. (FDA, 21 CFR 312.32; ICH E2A and ICH E6). 
ALL SERIOUS adverse events that meet the above criteria MUST be immediately reported to the 
NCI via CTEP-AERS within the timeframes detailed in the table below. 
Hospitalization 
• 
Grade 1 
Timeframes 
• 
Grade 2 
Timeframes 
• 
Grade 3 
Timeframes 
• 
Grade 4 & 5 
Timeframes 
Resulting in 
Hospitalization ≥ 24 hrs. 
10 Calendar Days 
24-Hour; 
5 Calendar Days 
Not resulting in 
Hospitalization ≥ 24 hrs. 
Not required 
10 Calendar 
Days 
NOTE:  Protocol specific exceptions to expedited reporting of serious adverse events are found in 
the Specific Protocol Exceptions to Expedited Reporting detailed below. 
Expedited AE reporting timelines are defined as: 
o “24-Hour; 5 Calendar Days” - The AE must initially be reported via CTEP-AERS ≤ 24 hours 
of learning of the AE, followed by a complete expedited report ≤ 5 calendar days of the 
initial 24-hour report. 
o “10 Calendar Days” - A complete expedited report on the AE must be submitted ≤ 10 
calendar days of learning of the AE. 
1 Serious adverse events that occur more than 30 days after the last administration of investigational 
agent/intervention and have an attribution of possible, probable, or definite require reporting as 
follows:  
Expedited 24-hour notification followed by complete report ≤ 5 calendar days for: 
• 
All Grade 4, and Grade 5 AEs  
Expedited 10 calendar day reports for: 
• 
Grade 2 adverse events resulting in hospitalization or prolongation of hospitalization  
• 
Grade 3 adverse events 
 

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• 
Expedited AE reporting timelines defined: 
 “24 hours; 5 calendar days” – The investigator must initially report the AE via CTEP-
AERS ≤ 24 hours of learning of the event followed by a complete CTEP-AERS report ≤ 5 
calendar days of the initial 24-hour report. 
 “10 calendar days” - A complete CTEP-AERS report on the AE must be submitted ≤ 10 
calendar days of the investigator learning of the event.  
• 
Any medical event equivalent to CTCAE grade 3, 4, or 5 that precipitates hospitalization (or 
prolongation of existing hospitalization) must be reported regardless of attribution and 
designation as expected or unexpected with the exception of any events identified as protocol-
specific expedited adverse event reporting exclusions (see below). 
• 
Any event that results in persistent or significant disabilities/incapacities, congenital anomalies, 
or birth defects must be reported via CTEP-AERS if the event occurs following treatment with 
an agent under a CTEP IND. 
• 
Use the NCI protocol number and the protocol-specific patient ID provided during trial 
registration on all reports. 
9.3.3 Additional Instructions or Exclusion to CTEP-AERS Expedited Reporting 
Requirements for Alliance A231601CD 
All adverse events reported via CTEP-AERS (i.e., serious adverse events) should also be 
forwarded to your local IRB. 
Death due to progressive disease should be reported as Grade 5 “Disease progression” in 
the system organ class (SOC) “General disorders and administration site conditions.”  
Evidence that the death was a manifestation of underlying disease (e.g., radiological 
changes suggesting tumor growth or progression: clinical deterioration associated with a 
disease process) should be submitted.  
Any death occurring within 30 days of the last intervention, regardless of attribution to the 
investigational agent/intervention requires expedited reporting within 24 hours.  
Any death occurring greater than 30 days after the last intervention of the investigational 
agent/intervention requires expedited reporting within 24 hours only if it is possibly, 
probably, or definitely related to the investigational agent/intervention. 
All new malignancies must be reported via CTEP-AERS whether or not they are thought 
to be related to either previous or current treatment. All new malignancies should be 
reported, i.e. solid tumors (including non-melanoma skin malignancies), hematologic 
malignancies, myelodysplastic syndrome/acute myelogenous leukemia, and in situ tumors. 
In CTCAE version 4.0, the new malignancies (both second and secondary) may be reported 
as one of the following: (1) Leukemia secondary to oncology chemotherapy, (2) 
Myelodysplastic syndrome, (3) Treatment-related secondary malignancy, or (4) 
Neoplasms benign, malignant and unspecified-other. Whenever possible, the CTEP-AERS 
reports for new malignancies should include tumor pathology, history or prior tumors, prior 
treatment/current treatment including duration, any associated risk factors or evidence 
regarding how long the new malignancy may have been present, when and how the new 
malignancy was detected, molecular characterization or cytogenetics of the original tumor 
(if available) and of any new tumor, and new malignancy treatment and outcome, if 
available. 

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10.0 MEASURES 
10.1 
Definitions of endpoints 
Primary endpoint: Function at 8 weeks post-surgery as measured by the CHAMPS 
questionnaire. 
Secondary and exploratory endpoints: (1) Postoperative complications (Clavien-Dindo 
grades I-V) mortality, American College of Surgeons’ National Quality Improvement Program 
geriatric outcome variables, hospital length of stay, discharge to a facility, and hospital 
readmission within 8 and 12 weeks of surgery. (2) Penetration of the EFS screening tool among 
all eligible patients within each of the OPTI-Surg arms defined as the total number of eligible 
patients who underwent screening divided by the total number of eligible patients (actual point 
estimate will take into account site clustered, see statistical analysis plan). 
10.2 
Schedule of evaluations  
10.2.1 Schedule of evaluations for participating practices 
Practices will be evaluated by ORCA at baseline and at 6, 12, and 24 months following site 
activation. Practices will complete the Intervention Appropriateness Measure (IAM), the 
Acceptability of Intervention Measure (AIM), and the Feasibility of Intervention Measure 
(FIM) at baseline, and at 6, 12, and 24 months. 32 For practices allocated to the OPTI-Surg 
+ Coach arm, penetration will also be assessed after each PDSA cycle. 
Site visits will take place at 5 practices randomized to each arm. These site visits will take 
place prior to implantation of the OPTI-Surg intervention, after the fifth patient is enrolled 
at the practice, and 6 to 9 months after the last patient is enrolled at the practice.   
10.2.2 Schedule of evaluations for patients  
All eligible patients will be evaluated for surgical complications 8 and 12 weeks following 
surgery. 
Consenting patients will be evaluated for function as measured by the CHAMPS 
questionnaire at baseline and at 8 weeks following surgery.  Patients will also be evaluated 
for quality of life by the EQ-5D-5L at baseline and at 8 weeks following surgery. 
 
 

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10.3 
Practice-level reported measures 
10.3.1 Practice level postoperative morbidity 
Postoperative complications (Clavien-Dindo grades I-V)24 and ACS-NSQIP geriatric 
outcome variables will be assessed 8 and 12 weeks following surgery.  
Clavien-Dindo Classification of Surgical Complications 
Grade I 
Any deviation from the normal postoperative course without the need 
for pharmacological treatment or surgical, endoscopic, and radiological 
interventions. 
Grade II 
Requiring pharmacological treatment with drug other than such allowed 
for Grade I complications.  
Grade III 
Requiring surgical, endoscopic or radiological intervention. 
Grade IIIa 
Intervention not under general anesthesia.  
Grade IIIb 
Intervention under general anesthesia.  
Grade IV 
Life-threatening complication.  
Grade IVa 
Single organ dysfunction.  
Grade IVb 
Multiorgan dysfunction.  
Grade V 
Death of a patient. 
 
American College of Surgeons’ National Quality Improvement Program Geriatric Outcome Variables 
Postoperative occurrences 
Definition 
Postoperative pressure ulcer 
A pressure ulcer is present at discharge; did it occur during the hospital 
stay—yes/no 
Postoperative delirium 
Delirium is present if there are one or more episodes of acute confusion 
during hospitalization—yes/no 
Do not resuscitate (DNR) order 
during hospitalization 
New DNR order during hospitalization—yes/no 
Palliative care consult 
Palliative care consult obtained during hospitalization or patient made 
comfort care—yes/no 
Discharge functional health status 
Ability to perform activities of daily living at discharge—
independent/partially dependent/dependent 
Fall risk on discharge 
Fall risk at time of discharge—high/low 
Need of mobility aid on discharge 
New use of mobility aid walker/cane at time of discharge—yes/no) 
Discharge with/without services 
Home alone with self-care, home alone with skilled care, home with 
support and self-care, home with support and skilled care 
Death (yes versus no, with date and cause), hospital length of stay (computed as days between 
date of surgery and discharge date), discharge to a facility (yes versus no), and hospital 
readmission (yes versus no, with reason for readmission) within 8 and 12 weeks will be 
documented in the medical record and reported on electronic case report forms in Rave. 

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10.3.2 Penetration of the OPTI-Surg intervention (i.e., Practice level uptake) 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, 
see Appendix X. 
10.3.3 Organizational Readiness to Change Assessment (ORCA) 
The Organization Readiness to Change Assessment (ORCA) will be used to characterize 
the practice sites’ readiness to implement the OPTI-Surg intervention at baseline, 6, 12, 
and 24 months and will be used as a diagnostic tool by the implementation coach (see 
Intervention with Implementation Coach). ORCA is a validated instrument that assesses 
key factors thought to be important in implementing change at the organizational level.25 
The scale has 77 items with three primary subscales: evidence, context, and facilitation.  
From each practice site, a mix of clinical and non-clinical staff will be asked to complete 
the survey. For each site, the following roles will be asked to complete the survey: the 
surgeon champion, nurse practitioner/nurse, and clinical operations manager. As sites 
agree to participate, the research team will contact the site to determine the above 
mentioned roles and ask the identified staff to complete the survey. The survey will be 
administered as an online survey or on paper. The average score will be taken from each 
practice site. 
10.3.4 Acceptability of Intervention Measure (AIM), Intervention Appropriateness 
Measure (IAM), and the Feasibility of Intervention Measure (FIM) 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, 
see Appendix X. 
10.3.5 Ethnographic Assessment 
Overview: Ethnography is a social science research method that uses qualitative data to 
provide insights into clinic culture, including how the organizational culture of medical 
practices shapes implementation of practice-improvement interventions.34-37  We will use 
ethnographic methods, including direct observation of clinic routines and interviews with 
stakeholders, to examine how organizational culture shapes clinic’s ability to implement 
OPTI-Surg as well as the longer term impact of the OPTI-Surg intervention on clinic 
culture and routines. 
Site Selection: We will include 5 sites from both of the two intervention arms (Opti-Surg, 
and OPTI-Surg with coach) and 2 sites from the control arm for a total of 12 study sites in 
the ethnographic assessment. This purposeful approach to site selection reflects our focus 
on understanding the relationship between clinic culture and Opti-Surg implementation as 
well as on how Opti-Surg shapes clinic culture. 
After randomization to one of the three study arms (see Section 4.3), 5 sites within each 
intervention arm will be selected for ethnographic assessment (a total of 10 sites). We will 
randomly select one site of each practice type (thoracic, major abdominal, urologic) from 
each intervention arm, for a total of 6 sites. The final 4 sites (2 from each intervention arm) 
will be purposefully selected to ensure that we include practices that are diverse with 
respect to geographic region, practice size, and patient populations. In addition to the 10 
intervention sites, we will also randomly select 2 sites from the control arm. 
Data Collection: Three data collection site visits will be conducted at each of the 12 
ethnographic study sites: a Baseline visit prior to enrollment of the first patient, an In-
Progress visit after the 5th patient is enrolled but before enrollment is complete, and a Post-

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Intervention visit 6-9 months after the last patient has enrolled (see Section 5.2 Site-level 
Study Calendar). All site visits will include direct observation of clinic routines and 
interviews with staff; the In-Progress site visit at the 10 intervention arm sites will also 
include interviews with patients. 
All site visits will be carried out by trained study personnel and will be scheduled and 
arranged in coordination with the study site to minimize clinic disruption and burden. 
During all site visits, observational data will be recorded via longhand field notes following 
standard ethnographic practice.38 Interviews will be audio recorded for later transcription 
and analysis. 
The table below summarizes the subjects and activities planned for each type of visit. 
Site Visit 
Activities & Subjects 
Baseline 
Clinic Observation: Up to 2 half-days observing clinic flow that may be 
impacted by OPTI-Surg intervention. 
Leadership Interviews (20-30 mins): Global assessment of clinic 
capacity and culture including awareness to needs of frail adults. 
Planned Enrollment: 4 /site (1 Practice Manager & 3 Surgeons) 
Implementation Interviews (15-20 mins): Document current care 
practices for older adults and planned deployment of OPTI-Surg at 
intervention sites. Planned Enrollment: 6-8/site (MA/RN/Mid-Level  
& Ancillary Service Providers) 
In-Progress 
Clinic Observation: Up to 2 half-days observing clinic flow that may be 
impacted by OPTI-Surg intervention. 
Leadership Interviews (20-30 mins): Global assessment of clinic 
capacity and culture including awareness to needs of frail adults. 
Planned Enrollment: 4 /site (1 Practice Manager & 3 Surgeons) 
Implementation Interviews (15-20 mins): Document current care 
practices for older adults and planned deployment of OPTI-Surg at 
intervention sites. Planned Enrollment: 6-8/site (MA/RN/Mid-Level  
& Ancillary Service Providers) 
Patient Interviews (30-45 mins): Document patient experiences of 
OPTI-Surg at Intervention sites. Planned Enrollment: 3/site at 
Intervention Sites only (30 patients total) 
Post-
Intervention 
Clinic Observation: Up to 2 half-days observing clinic flow that may be 
impacted by OPTI-Surg intervention. 
Leadership Interviews (20-30 mins): Global assessment of clinic 
capacity and culture including awareness to needs of frail adults. 
Planned Enrollment: 4 /site (1 Practice Manager & 3 Surgeons) 
Implementation Interviews (15-20 mins): Document current care 
practices for older adults and planned deployment of OPTI-Surg at 
intervention sites. Planned Enrollment: 6-8/site (MA/RN/Mid-Level  
& Ancillary Service Providers) 
 

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Baseline site visits will include the following elements. 
• 
Clinic Observation: Site visitors will spend up to 2 half-days observing routine clinic 
flow. These observations will provide insights into how the OPTI-Surg intervention 
might be implemented in the practice and into aspects of clinic culture such as how 
responsibility for patient-care activities are allocated among clinic staff and providers, 
how staff communicate with each other, and the routines that patients experience as 
they receive care in the clinic.  
• 
Leadership Interviews: Site visitors will conduct semi-structured interviews with the 
clinic practice manager and up to 3 surgeons. These interviews will provide a global 
perspective on clinic culture and the extent to which clinics are aware and responsive 
to needs of frail adults. We anticipate interviews will last 20-30 minutes; an interview 
guide is available at the Alliance and CTSU Web sites. 
• 
Implementation Interviews: Site visitors will conduct semi-structured interviews with 
6-8 front-line staff (Medical Assistants and Nurses), mid-level providers (Nurse 
Practitioners and Physician Assistants), and other service providers (Nutrition, 
Physical/Occupational Therapy, Mental Health, Social Work, etc.). These interviews 
will focus on the ways that these staff and providers are already engaged in care of 
frail adults as well as how they anticipate implementing OPTI-Surg at intervention 
sites. We anticipate interviews will last 15-20 minutes; an interview guide is available 
at the Alliance and CTSU Web sites. 
In-Progress site visits will include the following elements. 
• 
Clinic Observation: Procedures replicate those of Baseline visits. During the In-
Progress site visit, observations will focus on documenting how OPTI-Surg is being 
implemented at Intervention sites and whether there are notable practice changes in 
Control sites that may reflect secular change. 
• 
Leadership Interviews: Procedures replicate those of Baseline visits. During the In-
Progress site visit, visitors will document leadership experiences with the 
implementation of Opti-Surg at Intervention sites. They will document changes that 
have occurred in clinic routines or awareness of the needs of frail adults at Control 
sites. 
• 
Implementation Interviews: Procedures replicate those of Baseline visits. During the 
In-Progress site visit, visitors focus on staff and provider experiences implementing 
OPTI-Surg at Intervention sites and document any changes that have occurred in 
clinic routines or awareness of needs of frail adults at Control sites. 
• 
Patient Interviews: We will interview 3 patients who enrolled at each practice 
randomized to the OPTI-Surg arms. Prior to the visit, visitors will work with research 
staff to identify eligible patients and arrange to conduct an interview during the site 
visit. Interviews will be conducted in-person in a private setting where confidentiality 
can be maintained and that is convenient for the patient.  Interviews will last 
approximately 30 minutes and will focus on patients’ experiences of care including 
their experiences with the components of the OPTI-Surg intervention. an interview 
guide is available at the Alliance and CTSU Web sites. 
Post-Intervention site visits will include the following elements. 
• 
Clinic Observation: Procedures replicate those of Baseline visits. During the Post-
Intervention site visit, observations will focus on documenting the extent to which 
OPTI-Surg routines remain in place or have impacted ongoing clinical operations at 
Intervention sites as well as documenting any secular trends at Control sites. 

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• 
Leadership Interviews: Procedures replicate those of Baseline visits. During the Post-
Intervention site visit at Intervention sites, Leadership Interviews will document 
reflections and experiences related to OPTI-Surg and care of frail adults since the end 
of the study period. At Control sites, Leadership interviews will focus on reflections 
concerning the needs of frail adults and probe whether the clinic has adopted or 
considered adopting any interventions related to care for frail adults. 
• 
Implementation Interviews: Procedures replicate those of Baseline visits. During the 
Post-Intervention site visit at Intervention sites, site visitors at Intervention sites will 
use these interviews to obtain first-hand accounts of how clinic routines have been 
changed by OPTI-Surg. At control sites, these interviews will be used to document 
any changes that have occurred in clinic routines or awareness of needs of frail adults. 
Data Management: As soon as feasible after completion of site visits, longhand field notes 
will be expanded into full field reports and saved as word processing documents. Audio-
taped interviews will be transcribed by a professional transcription service and reviewed 
for accuracy. 
Field reports and interview transcripts will be entered into Atlas.ti, a software package that 
facilitates management and analysis of qualitative data. Using Atlas.ti, we will code all 
data. Coding is the process by which segments of text are “tagged” according to their 
thematic content. Each ethnographic research project has its own coding scheme, e.g. a 
unique list of themes or issues that are relevant to the project’s research question. 
Developing the coding scheme and applying the codes to the field data is a core data 
management task of any ethnographic analysis. The coding scheme will be developed by 
the OPTI-Surg research team, and the codes will be applied to the data by trained research 
assistants. During training, a portion of the data will be double-coded to ensure fidelity in 
the application of the coding scheme, and double coding will be carried out at intervals 
throughout the data management to ensure coding reliability. 
Data Analysis: Once the Atlas.ti dataset has been assembled and coded, we will carry out 
analyses to address the central study questions of this exploratory aim including (1) what 
are the barriers and facilitators at the clinic level to implementation and adoption of the 
OPTI-Surg intervention and (2) what are the longer term effects of the OPTI-Surg 
intervention on clinic culture and routines. 
• 
To address Question 1, data tagged with codes related to barriers and facilitators will 
be extracted from the Atlas database and reviewed by the analytical team. The analysis 
will focus on comparisons of data collected from sites in intervention study arms 
(OPTI-Surg v OPTI-Surg+coach) at different clinical practices to identify which 
barriers/facilitators impact OPTI-Surg implementation at all sites versus which 
barriers/facilitators are notable within specific study arms, clinical sites, geographic 
regions, patient populations, etc. 
• 
To address Question 2, we will examine data tagged with codes related to clinic 
culture and care routines. Our analysis will focus on examining how these data change 
over time, e.g. comparing data collected at Baseline v. In-Progress v. Post-
Intervention time periods across all three study arms (including usual care). These 
analysis will shed light on whether and how clinic culture or routines was impacted 
by OPTI-Surg as well as the extent to which any observed changes might be due to 
secular changes that are unrelated to the OPTI-Surg intervention. 
 
 

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10.4 
Patient-reported measures 
10.4.1 Frailty Assessment 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, 
see Appendix X. 
10.4.2 Functional Assessment (CHAMPS) 
Physical function will be measured preoperatively and 8 weeks after surgery using the 
CHAMPS questionnaire in patients who consent for this portion of the study. CHAMPS 
includes 41 questions that ask the senior to estimate the time spent on a range of activities 
in the previous week. It has been validated as a measure of recovery of physical function 
after surgery and significantly correlates with SF-36 Physical Function, pain with 
movement, and 6 minute walking test distance.26 
10.4.3 EQ-5D-5L 
EQ-5D-5L is a short, 6-question, instrument which assesses a patient’s health state. The 
addition of the EQ-5D-5L will allow for computation and comparison of health utilities 
between arms. 
11.0 END OF INTERVENTION 
11.1 
Duration of Intervention  
Patient-level intervention will continue until surgery. 
For practices randomized to the OPTI-Surg plus Coach arm, site-level intervention will 
continue until 24 weeks after site activation. 
11.2 
Follow-up  
11.2.1 Duration of follow up 
Patient level follow-up: Patients will be followed for surgical complications until 12 
weeks after surgery. 
Practice level follow-up: For practices selected to undergo site interviews, follow up will 
continue until 6-9 months after the last patient is registered at that practice.  
11.2.2 Extraordinary Medical Circumstances 
If, at any time the constraints of this protocol are detrimental to the patient's health and/or 
the patient no longer wishes to continue protocol therapy, protocol therapy shall be 
discontinued. In this event: 
• 
Document the reason(s) for discontinuation of therapy on data forms. 
• 
Follow the patient for protocol endpoints as required by the Study Calendar. 
11.3 
Managing ineligible patients and registered patients who never receive protocol 
intervention  
Definition of ineligible patient 
A study participant who is registered to the trial but does not meet all of the eligibility criteria 
is deemed to be ineligible.  

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Follow-up for ineligible patients who continue with protocol treatment 
Patients who are deemed ineligible after registering may continue protocol treatment, provided 
the treating physician, study chair, and executive officer agree there are no safety concerns if 
the patient continues protocol treatment. All scans, tests, and data submission are to continue as 
if the patient were eligible. Notification of the local IRB may be necessary per local IRB policies. 
Follow-up for patients who are registered, but who do not undergo surgery 
For all study participants who are registered to the trial but who never receive study intervention 
(regardless of eligibility), baseline and off-treatment notice data submission are required. See 
the Data Submission Schedule accompanying the All Forms Packet. 
12.0 STATISTICAL CONSIDERATIONS 
12.1 
Statistical design 
This is a cluster randomized trial to evaluate the effectiveness of OPTI-Surg at the practice level. 
Practices will be randomized in a 1:1:1 fashion to the OPTI-Surg package intervention alone, 
OPTI-Surg with an implementation coach, or usual care.  The comparison of coach versus no-
coach arms will provide data on which practice change strategies are effective while ensuring 
that strategies are feasible and acceptable. Our design also includes direct measurement of 
practice culture and intervention roll-out through mixed methods (surveys, observation, and 
qualitative interviews). These mixed-methods data will identify barriers to implementation and 
acceptability, inform continuous improvement of the intervention, and provide insights into how 
to tailor the intervention to individual practice sites to ensure effective dissemination.  The 
primary analysis will be conducted after the last enrolled patient has been followed for at least 
12 weeks. 
Interim analysis:  Futility will be declared if the p-value is ≥ 0.323 based on a non-binding 
Pocock boundary with a Lan-DeMets spending function after half the consented patients have 
been observed at 8 weeks (i.e., completed the CHAMPS).  We will also prospectively monitor 
enrollment (both number of practices and number of patients per practice) and modify the 
planned number of practices in order to lower the number of patients per practice if per-practice 
enrollment rates are slower than expected. 
12.2 
Endpoints 
12.2.1 Primary endpoint: CHAMPS total score 8 weeks after surgery.  Hypothesis:  Among 
surgical practices that are randomized to OPTI-Surg (with or without a coach), patient-
reported function will be higher as compared to the surgical practices randomized to usual 
care. 
Secondary endpoints: 
12.2.2 Postoperative complications (Clavien-Dindo grades I-V) within 12 weeks of surgery.  
Hypothesis:  Among surgical practices that are randomized to OPTI-Surg (with or without 

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a coach), a lower proportion of patients will experience postoperative complications as 
compared to the surgical practices randomized to usual care. 
12.2.3 Compliance with administration of the EFS.  Hypothesis:  Compliance with screening 
will be higher among surgical practices that are randomized to OPTI-Surg with a coach 
versus those without a coach. 
Exploratory endpoints:  
12.2.4 Postoperative mortality, hospital length of stay, discharge to a facility, and hospital 
readmission within 12 weeks of surgery. 
12.2.5 Subsequent administration of interventions as a result of the EFS. 
12.2.6 Barriers and facilitators to implementation through mixed-methods research. 
12.3 
Power and sample size 
Target sample size of 15 patients (maximum 25) per each of 30 surgical practices (450 patients 
total) is based on achieving 90% power with a two sided alpha of 0.05 using a generalized linear 
mixed model (with Gaussian link function) with a random practice effect to account for 
clustering within practice to compare function at 8 weeks between the combined OPTI-Surg no-
coach and coach arms versus usual care, adjusting for baseline function, with the following 
assumptions: 
1. Among patients who are 70 years of age or older, 59% will be identified as frail with 
potential maximal benefit from OPTI-Surg screening (we assume partial effectiveness 
[33% of the full effect size] of OPTI-Surg screening in the remaining 41% of patients who 
are not found to be frail based on effectiveness of the Li (2013)27 intervention in a non-
screened population). 
2. OPTI-Surg screening compliance will be 60% and 80% in the no-coach and coach arms. 
3. Impact of OPTI-Surg within frail and screened patients (versus frail patients in the usual 
care arm) is based on a prior study of a similar intervention showing mean CHAMPS score 
(kcal) of 23 versus 8 at 8 weeks post-surgery.27 The overall effect size, taking into account 
frailty rates and screening rates as described above, is a mean score (kcal) of 19.73 versus 
12.10 at 8 weeks post-surgery for the combined OPTI-Surg no-coach/coach arms and usual 
care arm, respectively (standardized effect size of 0.42 [based on a CHAMPS standard 
deviation of 18.3] for the difference between arms). This explicitly takes into account the 
following mean CHAMPS scores in patients of this study: 
a. Among frail patients in the OPTI-Surg arms who are screened, 8-week mean 
score=23.  
b. Among frail patients in the OPTI-Surg arms who are not screened, 8-week mean 
score=8.  
c. Among non-frail patients in the OPTI-Surg arms who are screened, 8-week mean 
score=23.  
d. Among non-frail patients in the OPTI-Surg arms who are not screened, 8-week mean 
score=18. 
e. Among frail patients in the usual care arm, 8-week mean score=8.  
f. 
Among non-frail patients in the usual care arm, 8-week mean score=18. 
4. Cluster effect will be 0.005.28 

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5. Standard deviation of the CHAMPS score (kcal) is 18.3.29 
6. Final evaluable sample size (11 patients at each of 30 practices) is inflated by 30% to 15 
patients at each of 30 practices (450 patients) to allow for missing primary endpoint data. 
Note, for the secondary endpoint of surgical complications, we anticipate a larger sample 
size (since all eligible patients without the individual consent will also be included) and 
much lower rate of missing data as these data are systematically captured in the medical 
record and can be extracted for most if not all patients. To ensure that the final sample size 
of 450 patients is met, we will allow high enrolling sites to enroll up to 25 patients (i.e., we 
will allow unequal enrollment across sites). Enrollment will be closely monitored centrally 
and intentionally controlled to achieve as much balance across sites as possible. Under the 
assumption that 3 sites enroll 25 patients (19 evaluable), 3 sites enroll 5 patients (3 
evaluable), and all other sites enroll 15 patients (11 evaluable; equally distributed across 
arms), power is minimally impacted (variance inflation factor changes from 1.05 to 1.056 
which has a negligible impact on power). Even under the maximal coefficient of variation 
of cluster sizes when cluster size is constrained at 25 and total sample size is constrained 
at 450, power remains at 90%.  
This evaluable sample size also provides 85% power to detect the 60% versus 80% OPTI-Surg 
screening rates between the no-coach and coach arms with a two-sided alpha of 0.05 using a 
generalized linear mixed model (with logit link function) with a random practice effect to 
account for clustering within practice.  Power estimation is based on simulation in R. 
While it is possible that the effect size observed in prior studies that included younger patients 
undergoing less risky surgery may be larger than in older patients undergoing higher risk 
procedures, it is also plausible that an individualized program that targets multiple domains of 
frailty may result in substantial improvements in functional recovery – even among the very 
frail.  Studies examining trajectories of functional recovery without prehabilitation, however, 
show that both community dwelling older adults and frail older nursing home residents, on 
average, achieve maximum functional recovery at 90 days after abdominal surgery. Based on 
this evidence, we expect that the benefits of targeted optimization of frailty traits will result in 
accelerated recovery across the spectrum of frailty and multi-comorbidity.18 To address this 
uncertainty, we will conduct an interim analysis as described in Section 9.1. Further, our target 
power of 90% for an effect size based on Li et al. (2013)27 maintains reasonable power (i.e., 
power ≥70%) for slightly smaller effect sizes in the event that the effect is not as robust in the 
present patient population.  Specifically, our sample size ensures 90% power to detect the 
standardized effect size of 0.42 based on Li et al. (2013), and has power of 80% and 70% power 
for effect sizes of 0.36 and 0.33, respectively. 
12.4 
Analysis plan 
12.4.1 To assess the balance in randomization, baseline characteristics captured at the patient-
level including age, gender, race, ethnicity, disease type, comorbidities, CHAMPS, EQ-
5D-5L index and EQ-5D-5L visual analog scale will be compared across randomization 
arms using a generalized linear mixed model using the appropriate link function based on 
the distribution of the variable with a random practice effect to account for clustering 
within practice.  Given the small number of sites, comparison of practice characteristics 
(e.g., practice volume; payer mix; solo, single specialty, or multi-specialty group practice; 
availability of geriatric specialists, palliative care providers, advanced practice providers, 

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patient navigators, on site occupational and physical therapy, social workers, pharmacists, 
dietetics, integrative medicine) across randomization arms will be descriptive. 
12.4.2 Primary analysis 
The primary analysis will employ a generalized linear mixed model (with Gaussian link 
function) with a random practice effect to account for clustering within practice and 
baseline CHAMPS as a covariate to compare 8-week CHAMPS between the combined 
OPTI-Surg no-coach and coach arms versus usual care. This analysis will include all 
eligible elderly patients who undergo major cancer surgery, consent to complete CHAMPS 
questionnaires, and have baseline and 8-week function measured. In supplemental analysis, 
we will compare pairwise between arms (coach vs usual care, no-coach vs usual care, and 
coach vs no-coach) using the same method. Supplemental analyses will include model-
based analysis with covariates from patient and practice characteristics which appear to 
differ among randomization arms. 
12.4.3 Secondary and exploratory analysis 
A generalized linear mixed model (with logit link function) with a random practice effect 
to account for clustering within practice will be used to compare postoperative 
complications within 12 weeks of surgery between the combined OPTI-Surg no-coach and 
coach arms versus usual care followed by pairwise comparisons. This analysis will also 
include all eligible elderly patients who undergo major cancer surgery (no documentation 
of postoperative complications will be considered as not having any postoperative 
complications). A generalized linear mixed model (with logit link function) with a random 
practice effect to account for clustering within practice will also be used to compare 
compliance rate for screening between the no-coach and coach arms. This analysis will 
include all eligible elderly patients with planned major cancer surgery.  Generalized linear 
mixed models (with appropriate link function based on the distribution of the outcome 
variable being compared) with a random practice effect to account for clustering within 
practice will be used to compare other surgical outcomes within 12 weeks of surgery and 
to compare EQ-5D-5L index and visual analog scale scores between the combined OPTI-
Surg no-coach and coach arms versus usual care.  Models for EQ-5D-5L scores will include 
the respective baseline EQ-5D-5L score as a covariate. In supplemental analysis, we will 
compare outcomes and EQ-5D-5L index and visual analog scale scores pairwise between 
arms (coach vs usual care, no-coach vs usual care, and coach vs no-coach) using the same 
method.  Supplemental analysis will also incorporate patient and practice characteristics 
which appear to differ among randomization arms. 
A variety of supplemental and exploratory analyses will be conducted primarily using 
descriptive analysis as well as model-based analysis (where applicable and supported by 
adequate sample size) including to describe the frequency of interventions implemented 
and to explore the relationship between site characteristics and likelihood of compliance. 
With the addition of the virtual EFS effective with Update #03 to the study, we will 
additionally explore whether outcomes differed according to EFS used (in-person vs. 
virtual). 
12.4.4 Missing data 
We first plan to minimize missing data prospectively through use of central data collection 
in Rave within the Alliance Statistics and Data Center with prospective monitoring of data 
consistency and completeness. Prospectively, we also plan a staged roll-out with monthly 
contact with practices to identity missing data problems early. Analytically, for the primary 

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analysis we will first compare baseline characteristics (age, gender, race, ethnicity, cancer 
surgery type) among the eligible elderly patients who undergo major cancer surgery with 
and without 8-week CHAMPS data. We next plan to use all observations available for the 
initial analysis followed by incorporation of propensity scores in weighted regression in 
supplemental analysis (assuming there are systematic differences observed in patients with 
and without missing data). We will also employ a variety of single and multiple imputation 
methods and results will be descriptively compared across all methods to assess for impact 
of assumptions on results. In the event of more than 30% missing data for the primary 
endpoint, we will focus the analysis primarily on the key secondary endpoint of 
postoperative complications as we expect relatively complete data for this endpoint. 
12.5 
Study Monitoring 
This study will be monitored by the Alliance Data Safety Monitoring Board (DSMB), an NCI-
approved functioning body. Reports containing efficacy, adverse event, and administrative 
information will be provided to the DSMB every six months as per NCI guidelines. 
 
 

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12.6 
Inclusion of Women and Minorities 
This study will not exclude potential subjects from participating in this study solely on the basis 
of ethnic origin, gender or socioeconomic status.  Efforts will be made to enroll individuals of 
all genders, races, and ethnic backgrounds. We do not expect a differential effect of the 
intervention by gender, race, or ethnicity. Predictions of accrual the anticipated accrual in 
subgroups defined by gender and race is: 
DOMESTIC PLANNED ENROLLMENT REPORT 
Racial Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American Indian/ 
Alaska Native 
1 
4 
5 
2 
12 
Asian 
8 
10 
0 
1 
19 
Native Hawaiian or 
Other Pacific Islander 
0 
1 
0 
0 
1 
Black or African 
American 
23 
31 
0 
0 
54 
White 
152 
209 
0 
0 
361 
More Than One Race 
1 
1 
1 
0 
3 
Total 
185 
256 
6 
3 
450 
Ethnic Categories: 
Hispanic or Latino – a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish 
culture or origin, regardless of race. The term “Spanish origin” can also be used in addition to “Hispanic 
or Latino.” 
Not Hispanic or Latino 
Racial Categories: 
American Indian or Alaskan Native – a person having origins in any of the original peoples of North, Central, 
or South America, and who maintains tribal affiliations or community attachment. 
Asian – a person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian 
subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the 
Philippine Islands, Thailand, and Vietnam. (Note: Individuals from the Philippine Islands have been 
recorded as Pacific Islanders in previous data collection strategies.)  
Black or African American – a person having origins in any of the black racial groups of Africa.  
Native Hawaiian or other Pacific Islander – a person having origins in any of the original peoples of Hawaii, 
Guam, Samoa, or other Pacific Islands. 
White – a person having origins in any of the original peoples of Europe, the Middle East, or North Africa. 

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13.0 GENERAL REGULATORY CONSIDERATIONS: WAIVERS OF CONSENT & REMOTE INFORMED 
CONSENT 
13.1 
Waivers of documentation of patient consent 
13.1.1 Medical record review 
Medical records for patients who do not consent to participate in this study will be reviewed 
for numbers of patients screened to participate, demographic information, types of surgery 
performed, and adverse events and surgical complications. These data will be collected in 
aggregate form. We request a waiver of documentation of informed consent for the 
collection of these data because this activity presents no more than minimal risk of harm 
to subjects for the following reasons: 
• 
Review of medical records by clinical research staff does not adversely affect the 
rights or welfare of subjects because medical record information is de-identified and 
will be collected as practice-level aggregate data, 
• 
Site-level review of medical records involves no more than minimal risk because the 
person accessing the information has undergone training in confidentiality of medical 
records, and the records are viewed solely to collect site-level aggregate data and only 
minimal information will be recorded for research purposes. Names of patients (and 
other unique identifiers) will not be recorded. 
HIPAA waiver or alteration: Although not required by the Alliance, since a waiver of 
documentation of consent has been granted by the CIRB for the collection of aggregate 
data for non-consenting subjects, if a site’s institutional policies dictate that they obtain a 
“HIPAA waiver of authorization” from their local IRB to review patient medical records 
and collect aggregate data, the site may do so.  This waiver does not need to be submitted 
to the CIRB but must be maintained with the regulatory documents for the study at the site, 
and be available for review by auditors if requested. Note: The data is completely de-
identified and there is no collection of Protected Health Information (PHI).   
13.1.2 Patient screening 
For practices randomized to Arm 2, see Appendix III; For practices randomized to Arm 3, 
see Appendix X. 
13.2 
Waivers of documentation of healthcare provider consent 
13.2.1 Human subjects involvement and characteristics 
The ethnographic component of this study will involve human subjects in two ways: 1) 
individual qualitative interviews with health care professionals and patients; 2) observation 
of cancer clinic routines. 
Research activities will take place at 12 sites with a total of approximately 150 subjects 
involved in these activities including 120 health care professions and 30 patients. All 
subjects will be 18 years or older with health statuses ranging from very healthy (no known 
illnesses) to extremely unhealthy (terminal disease). Inclusion criteria for all subjects will 
include ability to effectively communicate in English. 
The sites for this study will include 12 sites: 10 OPTI-Surg intervention sites and 2 usual 
care sites. 

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13.2.2 Sources of materials 
All data will be collected specifically for this research study. We will collect data using in-
depth interviews and direct observation. These are non-invasive social scientific research 
methods. In-depth interviews involve questions, answers, and conversation between 
researcher and subjects. Data is obtained through the long hand recording of field notes 
which are later expanded into full transcripts for later analysis. Direct observation involves 
spending time with subjects and observing their routine activities in a non-disruptive 
manner. Data is obtained by the researcher taking field notes, which are then expanded in 
to more detailed field reports after the researcher has left the field site. 
The data will be identified through pseudonyms and a coding scheme, and the key linking 
individual subject identifiers to the pseudonyms and codes we use while collecting data 
will only be accessible to the study team. 
13.2.3 Potential risks 
Potential risks to subjects from this research include those usually associated with non-
invasive social science research and are primarily related to possible social discomfort or 
embarrassment and potential loss of confidentiality. During direct observation, subjects 
may experience social discomfort or embarrassment due to the presence of the researcher. 
Because field notes and interviews will be recorded, there is also the possibility of loss of 
confidentiality. 
13.2.4 Recruitment 
To recruit health professionals (for interviews and observation) we will recruit subjects in 
conjunction with site enrollment in the primary OPTI-Surg study. As part of the site 
recruitment process, we will ask clinic leaders to identify appropriate clinic managers and 
front line staff for initial interviews and observation. Once on site, we will use snowball 
sampling techniques to identify and gather data from other relevant health professionals 
who have relevant patient care or clinic management duties. We will recruit patients by 
asking clinic managers to refer the researchers to 2-5 patients who have been seen at the 
clinic during the relevant study period.  
13.2.5 Informed consent 
Surgeons and Clinic Staff: Per the basic HHS Policy for Protection of Human Research 
Subjects at 45 CFR 46.117(c) we will request a waiver of written consent for participation 
in the ethnographic component of the study given the minimal risk nature of these 
activities. Participants in these activities will be provided with written information 
(Appendix VII) describing the research, their participation, the risks, possible benefits, and 
all other required elements of informed consent.  Additionally, because a signed consent 
form would be the only documentation of the participants’ identities, we feel a waiver of 
written consent is appropriate. Participants may drop out at any time before, during, or after 
the interview. 
13.2.6 Protections against risk 
To protect against risks of social discomfort, embarrassment, or concern that their 
responses may reflect unfavorably on their practice, researchers will inform subjects that 
they are free to end their participation in this research at any time by refusing to answer 
interview questions or by asking the researcher to cease observing activities in clinic. The 
component lead has substantial experience and expertise in these issues from his work in 

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prior research studies, and all train team members will be trained in issues that may arise 
when conducting this type of ethnographic research. 
To protect against loss of confidentiality, researchers will maintain control over all hard-
copy research materials including field notes and field reports by keeping them within their 
personal control during the conduct of research or by keeping them in a locked filing 
cabinet in the principal investigator’s research office.  Computer files containing field 
notes, field reports, and the Atlas.ti data base will be password protected. In field notes, 
researchers will identify subjects using pseudonyms. The key linking field note 
pseudonyms and interview numeric codes to actual subject names will be kept in the 
principal investigator’s locked file cabinet at all times except for when it is in active use. 
In papers, reports, publications, and other documents neither the names of individual 
research subjects nor the specific identities of research sites will be identified. Researchers 
will suppress or alter distinguishing features of subjects or field sites so that subjects remain 
anonymous. 
13.3 
Potential benefits of the proposed research to human subjects and others 
This project seeks to better understand how programs to improve surgical care for frail adults 
can be best implemented and thus may the potential to improve the processes for providing 
surgical care for this type of cancer patients. 
13.4 
Importance of the knowledge to be gained 
Identifying more effective ways to implement programs that seek to improve decision-making 
and preparation surrounding surgical oncology has the potential to improve patient and health 
system outcomes. 
13.5 
Remote Informed Consent 
The NCI CIRB allows “remote” informed consent (i.e., telephone/teleconferencing discussion 
in conjunction with an informed consent document that can be sent to the patient, signed, and 
transmitted back to the participating site research team and signed by the consenting 
physician/healthcare provider before any research procedures begin). Information on the NCI 
CIRB’s support for “remote” informed consent for sites using the NCI CIRB as the IRB of 
record is available on the NCI CIRB website at 
Sites must also follow their 
institutional policies regarding remote informed consent. Please contact the NCI CIRB at 
with questions regarding remote informed consent. 
 
 

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14.0 REFERENCES 
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9. 
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13. 
Li C, Carli F, Lee L, et al: Impact of a trimodal prehabilitation program on functional recovery 
after colorectal cancer surgery: a pilot study. Surg Endosc 27:1072-82, 2013. 
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Valkenet K, van de Port IG, Dronkers JJ, et al: The effects of preoperative exercise therapy on 
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Chow WB, Rosenthal RA, Merkow RP, et al: Optimal preoperative assessment of the geriatric 
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Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg 
215:453-66, 2012. 

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16. 
Ghignone F, van Leeuwen BL, Montroni I, et al: The assessment and management of older cancer 
patients: A SIOG surgical task force survey on surgeons' attitudes. Eur J Surg Oncol 42:297-302, 
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within primary care settings. Ann Fam Med 10:63-74, 2012. 
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Rolfson DB, Majumdar SR, Tsuyuki RT, et al: Validity and reliability of the Edmonton Frail 
Scale. Age Ageing 35:526-9, 2006. 
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Fried TR, Bradley EH, Towle VR, et al: Understanding the treatment preferences of seriously ill 
patients. N Engl J Med 346:1061-6, 2002. 
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Schwarze ML, Barnato AE, Rathouz PJ, et al: Development of a list of high-risk operations for 
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challenges, and research agenda. Adm Policy Ment Health 2011. 38:65-76. 
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Helfrich CD, Li YF, Sharp ND, et al: Organizational readiness to change assessment (ORCA): 
development of an instrument based on the Promoting Action on Research in Health Services 
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23. 
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Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal 
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Helfrich CD, Li YF, Sharp ND, et al: Organizational readiness to change assessment (ORCA): 
development of an instrument based on the Promoting Action on Research in Health Services 
(PARIHS) framework. Implement Sci 4:38, 2009. 
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Feldman LS, Kaneva P, Demyttenaere S, et al: Validation of a physical activity questionnaire 
(CHAMPS) as an indicator of postoperative recovery after laparoscopic cholecystectomy. 
Surgery 146:31-9, 2009. 
27. 
Li C, Carli F, Lee L, et al: Impact of a trimodal prehabilitation program on functional recovery 
after colorectal cancer surgery: a pilot study. Surg Endosc 27:1072-82, 2013. 
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Adams G, Gulliford MC, Ukoumunne OC, et al: Patterns of intra-cluster correlation from primary 
care research to inform study design and analysis. J Clin Epidemiol 57:785-94, 2004. 
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Stewart AL, Mills KM, King AC, et al: CHAMPS physical activity questionnaire for older adults: 
outcomes for interventions. Med Sci Sports Exerc 33:1126-41, 2001. 
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Englesbe MJ, Grenda DR, Sullivan JA, Derstine BA, Kenney BN, Sheetz KH, Palazzolo WC, 
Wang NC, Goulson RL, Lee JS, Wang SC. The Michigan Surgical Home and Optimization 
Program is a scalable model to improve care and reduce costs. 2017. Surgery 161(6):1659-1666. 
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Powell et al. A refined compilation of implementation strategies: Results from the Expert 
Recommendations for Implementing Change (ERIC) project. Implementation Science 10:21, 
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Weiner et al. Psychometric assessment of three newly developed implementation outcome 
measures. Implementation Science 12:108, 2017. 
33. 
Ritchie MJ, Dollar KM, Miller CJ, Oliver KA, Smith JL, Lindsay JA, Kirchner JE. Using 
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Based Behavioral Health, 2017. Available at: 
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34. 
Kellogg, K. C. (2009). Operating Room: Relational Spaces and Microinstitutional Change in 
Surgery. American Journal of Sociology, 115(3), 657–711. https://doi.org/10.1086/603535 
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Kellogg, K. C. (2014). Brokerage Professions and Implementing Reform in an Age of Experts. 
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DIXON-WOODS, M., BOSK, C. L., AVELING, E. L., GOESCHEL, C. A., & PRONOVOST, P. 
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Bosk, C. L., Dixon-Woods, M., Goeschel, C. A., & Pronovost, P. J. (2009). Reality check for 
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University of Chicago Press. 
 
 

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15.0 MODEL CONSENT FORM 
 
 
 

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Study Title for Participants: A study to improve outcomes in older cancer patients 
undergoing surgery 
 
Official Study Title for Internet Search on 
Improving 
surgical care and outcomes in older cancer patients through implementation of an efficient 
pre-surgical toolkit (OPTI-Surg) 
 
Overview and Key Information  
What am I being asked to do? 
We are asking you to take part in a research study.  The study has public funding from the 
National Cancer Institute (NCI), part of the National Institutes of Health (NIH) in the United 
States Department of Health and Human Services. We do research studies to try to answer 
questions about how to prevent, diagnose, and treat diseases like cancer. 
You are being asked to take part in this study because you are 70 years of age or older and are 
preparing to have major cancer surgery.  
Taking part in this study is your choice.  
You can choose to take part or you can choose not to take part in this study.  You also can 
change your mind at any time.  Whatever choice you make, you will not lose access to your 
medical care or give up any legal rights or benefits. 
This document has important information to help you make your choice. Take time to read it.  
Talk to your doctor, family, or friends about the risks and benefits of taking part in the study.  
It’s important that you have as much information as you need and that all your questions are 
answered.  See the “Where can I get more information?” section for resources for more clinical 
trials and general cancer information. 
Why is this study being done? 
This study is being done to answer the following question:  
Can changing how doctors evaluate and prepare elderly patients for major cancer surgery 
improve the rate of recovery from surgery? 
What is the usual approach to my diagnosis? 
The usual approach for patients who are not in a study is to get advice about cancer surgery from 
their doctor. 

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What are my choices if I decide not to take part in this study? 
•
You may choose to have the usual approach described above without completing
questionnaires about your physical, emotional, and social well-being and how well you
are functioning.
•
You may choose to take part in a different research study, if one is available.
What will happen if I decide to take part in this study? 
If you decide to take part in the study, you will be asked to complete questionnaires about your 
physical, emotional, and social well-being and how well you are functioning.  You will be asked 
to complete these questionnaires at the following time points:   
•
After you enroll to the study
•
8 weeks after you complete your surgery
These questionnaires should take about 20 to 30 minutes to complete. 
In addition, you may be selected to meet with researchers in a private, confidential setting that is 
convenient for you for an interview that will last about 30 minutes and will focus on your 
experiences with the surgical team while preparing for surgery. 
What are the risks and benefits of taking part in this study? 
There are both risks and benefits to taking part in this study.  It is important for you to think 
carefully about these as you make your decision.     
Risks 
We want to make sure you know about a few key risks right now.  We give you more 
information in the “What risks can I expect from taking part in this study?” section. 
•
You may be asked sensitive or private questions which you normally do not discuss. You
may choose not to answer any questions that make you feel uncomfortable.
Benefits 
You are not expected to have any direct medical benefit from participating in this study. 
However, it may help the study doctors learn more about how doctors and clinics are helping 
patients prepare for cancer surgery.   
If I decide to take part in this study, can I stop later? 
Yes, you can decide to stop taking part in the study at any time. 
If you decide to stop, let your study doctor know as soon as possible. You also may choose to 
stop participation or skip any questions in the surveys that you do not feel comfortable 
answering. 
Your study doctor will tell you about new information or changes in the study that may affect 
your health or your willingness to continue in the study. 

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Are there other reasons why I might stop being in the study? 
Yes.  The study doctor may take you off the study if: 
• 
Your health changes and the study is no longer in your best interest. 
• 
New information becomes available and the study is no longer in your best interest. 
• 
You do not follow the study rules. 
• 
The study is stopped by the National Cancer Institute (NCI), Institutional Review Board 
(IRB), or study sponsor (the Alliance).  The study sponsor is the organization who 
oversees the study.   
This study is conducted by the Alliance for Clinical Trials in Oncology, a national clinical 
research group supported by the National Cancer Institute. The Alliance is made up of cancer 
doctors, health professionals, and laboratory researchers, whose goal is to develop better 
treatments for cancer, to prevent cancer, to reduce side effects from cancer, and to improve the 
quality of life of cancer patients. 
It is important that you understand the information in the informed consent before making 
your decision. Please read, or have someone read to you, the rest of this document. If there is 
anything you don’t understand, be sure to ask your study staff or nurse. 
What is the purpose of this study? 
Surgery is the main treatment for many cancer conditions.  In many elderly patients, surgery can 
greatly affect physical condition, and the ability to return to pre-surgery levels of physical 
functioning. By providing some simple pre-surgical recommendations, it may be possible to 
improve the rate of recovery from surgery and the possibility that patients will return to their pre-
surgery levels of function. 
Your doctors are participating in a study to determine if a change in how they evaluate and 
manage elderly patients will improve recovery rates from major cancer surgery. Doctors and 
members of the surgical team will use a group of assessment tools called “OPTI-Surg” that helps 
them make pre-surgery referrals and recommendations.  The research study team wants to find 
out if using OPTI-Surg to guide pre-surgical referrals and recommendations can help improve 
recovery for elderly patients after cancer surgery.   
There will be about 450 people taking part in this study (about 15 to 25 people in this clinic). 
 
 

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What are the study groups? 
Clinics that choose to take part in this study will be assigned to one of three groups.  A computer 
will assign each clinic to a group by chance.  This is called randomization.  Assignment is done 
by chance because no one knows if one study group is better or worse than the others.  Clinics 
that choose to take part in this study will be randomized to one of the following three groups. 
Clinic Group 1:  At clinics assigned to Group 1, the OPTI-Surg program will not be used. 
The study will not ask these clinics to change what they usually do.  For patients at these 
clinics, care will not be different from care that they would receive outside the study. There 
are ten clinics participating in the study in Group 1. 
Clinic Group 2:  At clinics assigned to Group 2, the OPTI-Surg program will be used.  
Clinics will be trained to administer the program.  You may receive recommendations about 
how to prepare for surgery as part of this program.  There are ten clinics participating in the 
study in Group 2. 
Clinic Group 3:  At clinics assigned to Group 3, the OPTI-Surg program will also be used.  
Clinics will be trained to administer the program. In addition, clinics in Group 3 will have a 
“coach” to help with the implementation of the OPTI-Surg program.  You may receive 
recommendations about how to prepare for surgery as part of this program.  There are ten 
clinics participating in the study in Group 3. 
Your clinic has been assigned to Group ___. 
What exams, tests, and procedures are involved in this study? 
You will be asked to complete questionnaires about your physical, emotional, and social well-
being and how well you are functioning.  You will be asked to complete these questionnaires at 
the following time points:   
• 
After you enroll to the study  
• 
8 weeks after you complete your surgery 
These questionnaires should take about 20 to 30 minutes to complete.  
In addition, you will have blood sample taken at your first appointment with your surgeon and 8 
weeks after surgery. 
Lastly, you may be selected to meet with researchers in a private, confidential setting that is 
convenient for you for an interview that will last about 30 minutes and will focus on your 
experiences with the study procedures. 
Information from your medical records will be obtained at the following times:  
• 
After you enroll to the study  
• 
8 and 12 weeks after you complete your surgery 

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The researchers will obtain the following information from your medical record: 
• 
Basic information about you (e.g., gender, height, weight) 
• 
Type of cancer and surgery performed 
• 
Your medical history, current medical issues, health status 
What risks can I expect from taking part in this study? 
If you choose to take part in this study, there is a risk that: 
• 
You may lose time at work or home and spend more time in the hospital or doctor’s 
office than usual 
• 
You may be asked sensitive or private questions which you normally do not discuss. You 
may choose not to answer any questions that make you feel uncomfortable. 
Here are important points about side effects: 
• 
The study doctors do not know who will or will not have side effects. 
• 
Some side effects may go away soon, some may last a long time, or some may never go 
away. 
As part of the study, your health care team may recommend different ways that you can prepare 
for your surgery. It is possible that you may experience side effects after following these 
recommendations. Tell the study doctor if you notice or feel anything different so they can see if 
you are having a side effect. The study doctor may be able to treat some side effects. 
What are my responsibilities in this study? 
If you choose to take part in this study you will need to: 
• 
Keep your study appointments. 
• 
Complete the questionnaires after you enroll to the study and 8 weeks after you complete 
your surgery 
• 
Tell your doctor about: 
o all medications and supplements you are taking 
o any side effects  
o any doctors’ visits or hospital stays outside of this study  
o if you have been or are currently in another research study. 
 
 

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What are the costs of taking part in this study? 
You and/or your insurance plan will need to pay for the costs of medical care just as you would 
if you were getting the usual care for your cancer.   
Talk to your insurance provider and make sure that you understand what your insurance pays for 
and what it doesn’t pay for if you take part in this clinical trial.  Also, find out if you need 
approval from your plan before you can take part in the study.  
Ask your doctor or nurse for help finding the right person to talk to if you are unsure which costs 
will be billed to you or your insurance provider. 
Taking part in this study may mean that you need to make more visits to the clinic or hospital 
than if you were getting the usual approach to treat your cancer.  You may: 
• 
Have more travel costs. 
• 
Need to take more time off work. 
• 
Have other additional personal costs. 
You will not be paid for taking part in this study.  The research may lead to new tests, drugs, or 
other products for sale.  If it does, you will not get any payment. 
What happens if I am injured because I took part in this study? 
If you are injured as a result of taking part in this study and need medical treatment, please talk 
with your study doctor right away about your treatment options.  The study sponsors will not pay 
for medical treatment for injury.  Your insurance company may not be willing to pay for a study-
related injury.  Ask them if they will pay.  If you do not have insurance, then you would need to 
pay for these medical costs. 
If you feel this injury was caused by medical error on the part of the study doctors or others 
involved in the study, you have the legal right to seek payment, even though you are in a study.  
Agreeing to take part in this study does not mean you give up these rights. 
Who will see my medical information? 
Your privacy is very important to us.  The study doctors will make every effort to protect it.  The 
study doctors have a privacy permit to help protect your records if there is a court case.  
However, some of your medical information may be given out if required by law.  If this should 
happen, the study doctors will do their best to make sure that any information that goes out to 
others will not identify who you are.  
Some of your health information, such as your response to cancer treatment, results of study 
tests, and medicines you took, will be kept by the study sponsor in a central research database.  
However, your name and contact information will not be put in the database.  If information 
from this study is published or presented at scientific meetings, your name and other personal 
information will not be used.  

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There are organizations that may look at or receive copies of some of the information in your 
study records.  Your health information in the research database also may be shared with these 
organizations.  They must keep your information private, unless required by law to give it to 
another group.   
• 
The study sponsor (Alliance) 
• 
The NCI Central IRB, which is a group of people who review the research with the goal 
of protecting the people who take part in the study. 
• 
The NCI and the groups it works with to review research. 
• 
The NCI’s National Clinical Trials Network and the groups it works with to conduct 
research  
In addition to storing data in the study database, data from studies that are publicly funded may 
also be shared broadly for future research with protections for your privacy. The goal of this data 
sharing is to make more research possible that may improve people’s health. Your study records 
may be stored for future use in public databases.  However, your name and other personal 
information will not be used.   
Some types of future research may include looking at your information and information from 
other patients.  However, right now we don’t know what research may be done in the future 
using your information.  This means that: 
• 
You will not be asked if you agree to take part in the specific future research studies 
using your health information.   
• 
You and your surgeon will not be told when or what type of research will be done. 
• 
You will not get reports or other information about any research that is done using your 
information.  
Where can I get more information?   
You may visit the NCI web site at 
for more information about studies or 
general information about cancer.  You may also call the NCI Cancer Information Service to get 
the same information at: 
 
A description of this clinical trial will be available on 
as required 
by U.S. Law.  This Web site will not include information that can identify you.  At most, the 
Web site will include a summary of the results.  You can search this Web site at any time. 
You can talk to the study staff about any questions or concerns you have about this study.  
Contact the study staff (*insert name of study staff*) at (*insert telephone number, and email 
address if appropriate*). 
For questions about your rights while in this study, call the (*insert name of organization or 
center*) Institutional Review Board at (*insert telephone number*).  
 
 

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My signature agreeing to take part in the study 
I have read this consent form or had it read to me.  I have discussed it with the study doctor and 
my questions have been answered.  I will be given a signed and dated copy of this form.  I agree 
to take part in the main study.  
 
Participant’s signature 
 
 
 
 
Date of signature 
 
 
 
 
Signature of person(s) conducting the informed consent discussion 
 
 
 
 
Date of signature 
  
 
 
 
 

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APPENDIX I 
CHAMPS AND EQ-5D-5L QUESTIONNAIRES 
 
 
 
 
 
 

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Patient Booklet 
 
__________________________________________________________________________________ 
 
You have been given a booklet to complete for this study.  The booklet contains some questions about 
your ‘quality of life’ and your level of activity as a patient undergoing surgery for cancer.  Your 
answers will help us to better understand how surgery is affecting the way you feel. 
 
 
1. This booklet contains two sets of questions:  
 
a. CHAMPS Activities Questionnaire for Older Adults (41 questions) 
b. EQ-5D-5L Questionnaire (6 questions) 
 
2. Please follow the directions at the top of each questionnaire. 
 
3. You may choose not to answer any questions that make you feel uncomfortable. 
 
4. Please complete the booklet during your scheduled clinical visit and return it to your nurse, 
physician, or research coordinator. 
 
 
Thank you for taking the time to help us. 
 
 
 
 
 
 

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Update #04 
 
 
 
 
 
 
 
CHAMPS Activities Questionnaire for Older Adults 
 
 
 
 
 
 
 
 
 
 
 
CHAMPS: 
 
  
 
 
(11/06/00) © Copyright 1998  
 
Do not reproduce without permission of the CHAMPS staff 
Contact: 
 
 
 
Date:_________________________________ 
 
Name or ID:___________________________ 
 

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Update #04 
This questionnaire is about activities that you may have done in the past 4 weeks.  The questions on the following pages are 
similar to the example shown below. 
INSTRUCTIONS 
 
If you DID the activity in the past 4 weeks: 
Step #1 Check the YES box.  
Step #2 Think about how many TIMES a week you usually did it, and write your response in the  
space provided. 
Step #3 Circle how many TOTAL HOURS in a typical week you did the activity.  
 
Here is an example of how Mrs. Jones would answer question #1:  Mrs. Jones usually visits her friends Maria and Olga twice a week.  She 
usually spends one hour on Monday with Maria and two hours on Wednesday with Olga.  Therefore, the total hours a week that she visits with 
friends is 3 hours a week. 
 
In a typical week during the past 4 weeks, did you…  
 
 
 
 
 
 
 
1. Visit with friends or family (other than those you 
live with)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
If you DID NOT do the activity: 
• 
Check the NO box and move to the next question 
 
 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
1. Visit with friends or family (other than those you 
live with)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
2. Go to the senior center? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
3. Do volunteer work?  
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
4. Attend church or take part in church activities? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
5. Attend other club or group meetings? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
6. Use a computer? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
7. Dance (such as square, folk, line, ballroom) (do 
not count aerobic dance here)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
8. Do woodworking, needlework, drawing, or other 
arts or crafts? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
9. Play golf, carrying or pulling your equipment 
(count walking time only)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
10. Play golf, riding a cart (count walking time 
only)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
11. Attend a concert, movie, lecture, or sport event? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
12. Play cards, bingo, or board 
games with other people? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
13. Shoot pool or billiards? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
14. Play singles tennis (do not count doubles)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
15. Play doubles tennis (do not count singles)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
16. Skate (ice, roller, in-line)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
17. Play a musical instrument? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
18. Read? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
19. Do heavy work around the house (such as 
washing windows, cleaning gutters)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
20. Do light work around the house (such as 
sweeping or vacuuming)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
21. Do heavy gardening (such as spading, raking)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
22. Do light gardening (such as watering plants)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
23. Work on your car, truck, lawn mower, or other 
machinery? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
**Please note:  For the following questions about running and walking, include use of a treadmill. 
 
24. Jog or run? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

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Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
25. Walk uphill or hike uphill (count only uphill 
part)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
26. Walk fast or briskly for exercise (do not count 
walking leisurely or uphill)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
27. Walk to do errands (such as to/from a store or to 
take children to school (count walk time only)?  
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
28. Walk leisurely for exercise or pleasure? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
29. Ride a bicycle or stationary cycle? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

Alliance A231601CD 
69 
Version Date: 09/16/2021 
 
 
 
 
Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
30. Do other aerobic machines such as rowing, or 
step machines (do not count treadmill or stationary 
cycle)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
31. Do water exercises (do not count other 
swimming)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
32. Swim moderately or fast? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
33. Swim gently? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
34. Do stretching or flexibility exercises (do not 
count yoga or Tai-chi)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

Alliance A231601CD 
70 
Version Date: 09/16/2021 
 
 
 
 
Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
35. Do yoga or Tai-chi? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
36. Do aerobics or aerobic dancing? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
37. Do moderate to heavy strength training (such as 
hand-held weights of more than 5 lbs., weight 
machines, or push-ups)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
38. Do light strength training (such as hand-held 
weights of 5 lbs. or less or elastic bands)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 

Alliance A231601CD 
71 
Version Date: 09/16/2021 
 
 
 
 
Update #04 
In a typical week during the past  
4 weeks, did you … 
 
 
 
 
 
 
 
 
39. Do general conditioning exercises, such as light 
calisthenics or chair exercises (do not count strength 
training)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
40. Play basketball, soccer, or racquetball (do not 
count time on sidelines)? 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
41. Do other types of physical activity not 
previously mentioned  (please specify)? 
 
__________________________ 
 YES   How many times a week?_____  
 NO 
 
How many TOTAL hours a 
week did you usually do it? 
 
Less than  
1 hour 
 
1-2½ 
hours 
 
3-4½ 
hours 
 
5-6½ 
hours 
 
7-8½ 
hours 
9 or more 
hours 
 
 
Thank You 
 
 
 
 

Alliance A231601CD 
72 
Version Date: 09/16/2021 
Update #04 
EQ-5D-5L Questionnaire 
Under each heading, please check the ONE box that best describes your health TODAY 
 
MOBILITY 
I have no problems walking 
  
 
 
 
I have slight problems walking   
 
 
 
I have moderate problems walking 
  
 
 
I have severe problems walking   
 
 
 
I am unable to walk 
 
 
 
 
 
 
 
SELF-CARE 
I have no problems washing or dressing myself   
 
I have slight problems washing or dressing myself  
 
I have moderate problems washing or dressing myself   
I have severe problems washing or dressing myself  
 
I am unable to wash or dress myself  
 
 
 
 
USUAL ACTIVITIES (e.g. work, study, housework,  
family or leisure activities) 
I have no problems doing my usual activities  
 
 
I have slight problems doing my usual activities   
 
I have moderate problems doing my usual activities  
 
I have severe problems doing my usual activities  
 
I am unable to do my usual activities  
 
 
 
 
PAIN / DISCOMFORT 
I have no pain or discomfort  
 
 
 
 
I have slight pain or discomfort   
 
 
 
I have moderate pain or discomfort  
 
 
 
I have severe pain or discomfort  
 
 
 
I have extreme pain or discomfort  
 
 
 
 
ANXIETY / DEPRESSION 
I am not anxious or depressed   
 
 
 
I am slightly anxious or depressed  
 
 
 
I am moderately anxious or depressed   
 
 
I am severely anxious or depressed  
 
 
 
I am extremely anxious or depressed  
 
 
 
 
USA (English) © 2009 EuroQol Group. EQ-5D™ is a trade mark of the EuroQol Group 

Alliance A231601CD 
73 
Version Date: 09/16/2021 
Update #04 
 
 
• We would like to know how good or bad your health is  
TODAY. 
• This scale is numbered from 0 to 100. 
• 100 means the best health you can imagine. 
0 means the worst health you can imagine. 
• Mark an X on the scale to indicate how your health is TODAY. 
• Now, please write the number you marked on the scale in the box 
below.  
 
 
 
 
 
YOUR HEALTH TODAY = 
 
 
 
 
 
 
 
 
 
 
 
 
USA (English) © 2009 EuroQol Group. EQ-5D™ is a trade mark of the EuroQol Group 
 
10 
0 
20 
30 
40 
50 
60 
80 
70 
90 
100 
5 
15 
25 
35 
45 
55 
75 
65 
85 
95 
The best health      
 you can imagine 
The worst health    
 you can imagine 

Alliance A231601CD 
74 
Version Date: 09/16/2021 
Update #04 
APPENDIX II 
ORCA SURVEY 
 
 

Alliance A231601CD 
75 
Version Date: 09/16/2021 
Update #04 
Adapted from the Organizational Readiness for Change Assessment (ORCA) Survey 
 
PART I. Evidence Assessment  
 
Finding:  Implementing the OPTI-Surge intervention (Edmonton Frail Scale and Targeted 
Recommendations) into surgical oncology practice will improve the health outcomes of older 
patients with cancer. 
 
1. Based on your assessment of the evidence basis 
for this statement, please rate the strength of the 
evidence in your opinion, on a scale of 1 to 5 
where 1 is very weak evidence and 5 is very 
strong evidence: 
Very 
Weak 
Weak 
Neither 
weak nor 
strong 
Strong 
Very 
Strong 
Don’t 
Know/Not 
Applicable 
 
 
 
 
 
 
 
2. Now, please rate the strength of the evidence 
basis for this statement based on how you think 
respected clinical experts in your institution feel 
about the strength of the evidence, on a 1 to 5 
scale similar to the one above: 
Very 
Weak 
Weak 
Neither 
Weak 
nor 
Strong 
Strong 
Very 
Strong 
Don’t 
Know/Not 
Applicable 
 
 
 
 
 
 
 
PART II. Context Assessment 
For each of the following statements, please rate the strength of your agreement with the statement, from 
1 (strongly disagree) to 5 (strongly agree 
 
3. In general, senior leadership/clinical 
management in your organization: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) reward clinical innovation and creativity to 
improve patient care 
 
 
 
 
 
 
b) Solicit opinions of clinical staff regarding 
decisions about patient care 
 
 
 
 
 
 
c) Seek ways to improve patient education and 
increase patient participation in treatment 
 
 
 
 
 
 
 
4. In general, staff members in your 
organization 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) Have a sense of personal responsibility for 
improving patient care and outcomes 
 
 
 
 
 
 
b) cooperate to maintain and improve 
effectiveness of patient care 
 
 
 
 
 
 
c) are willing to innovate and/or experiment to 
improve clinical procedures 
 
 
 
 
 
 
d) are receptive to change in clinical processes 
 
 
 
 
 
 
 
 
 

Alliance A231601CD 
76 
Version Date: 09/16/2021 
Update #04 
5. In general, senior leadership/clinical 
management in your organization: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) provide effective management for 
continuous improvement of patient care 
 
 
 
 
 
 
b) clearly define areas of responsibility and 
authority for clinical managers and staff 
 
 
 
 
 
 
c) promote team building to solve clinical care 
problems 
 
 
 
 
 
 
d) promote communication among clinical 
services and units 
 
 
 
 
 
 
 
6. If your organization was going to implement 
OPTI-Surg for older patients with cancer, 
senior leadership/clinical management in 
your organization would: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) provide staff with information on your 
organization’s performance measures and 
guidelines 
 
 
 
 
 
 
b) establish clear goals for patient care 
processes and outcomes 
 
 
 
 
 
 
c) provide staff members with feedback/data 
on effects of clinical decisions 
 
 
 
 
 
 
d) hold staff members accountable for 
achieving results 
 
 
 
 
 
 
 
7. Regarding cancer care for older patients with 
cancer, opinion leaders in your organization: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) believe that the current practice patterns can 
be improved 
 
 
 
 
 
 
b) encourage and support changes in practice 
patterns to improve patient care 
 
 
 
 
 
 
c) are willing to try new clinical protocol 
 
 
 
 
 
 
d) work cooperatively with senior 
leadership/clinical management to make 
appropriate changes 
 
 
 
 
 
 
 
 
 

Alliance A231601CD 
77 
Version Date: 09/16/2021 
Update #04 
8. If there is agreement that change needs to 
happen for older patients with cancer: 
 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) we have the necessary support in terms of 
budget or financial resources 
 
 
 
 
 
 
b) we have the necessary support in terms of 
training 
 
 
 
 
 
 
c) we have the necessary support in terms of 
facilities 
 
 
 
 
 
 
d) we have the necessary support in terms of 
staffing  
 
 
 
 
 
 
 
PART III. Facilitation Assessment 
For each of the following statements, please rate the strength of your agreement with the statement, from 
1 (strongly disagree) to 5 (strongly agree) regarding implementing the OPTI-Surg for older patients with 
cancer: 
 
9. Senior leadership/clinical management 
would: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) propose a project that is appropriate and 
feasible 
 
 
 
 
 
 
b) provide clear goals for improvement in 
patient care 
 
 
 
 
 
 
c) establish a project schedule and deliverables 
 
 
 
 
 
 
d) designate a clinical champion(s) for the 
project 
 
 
 
 
 
 
 
10. The project clinical champion: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) accepts responsibility for success of this 
project 
 
 
 
 
 
 
b) has authority to carry out implementation 
 
 
 
 
 
 
c) is considered a clinical opinion leader 
 
 
 
 
 
 
d) works well with the intervention team and 
providers 
 
 
 
 
 
 
 
 
 

Alliance A231601CD 
78 
Version Date: 09/16/2021 
Update #04 
11. Senior leadership/clinical management/staff 
opinion leaders would: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) agree on the goals for this intervention 
 
 
 
 
 
 
b) be informed and involved in the 
intervention 
 
 
 
 
 
 
c) agree on adequate resources to accomplish 
the intervention 
 
 
 
 
 
 
d) set a high priority on the success of the 
intervention  
 
 
 
 
 
 
 
12. The implementation team members would: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) share responsibility for the success of this 
project 
 
 
 
 
 
 
b) have clearly defined roles and 
responsibilities 
 
 
 
 
 
 
c) have release time or can accomplish 
intervention tasks within their regular work 
load 
 
 
 
 
 
 
d) have staff support and other resources 
required for the project 
 
 
 
 
 
 
 
13. The implementation plan for this 
intervention would: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) identify specific roles and responsibilities 
 
 
 
 
 
 
b) clearly describes tasks and timelines 
 
 
 
 
 
 
c) include appropriate provider/patient 
education 
 
 
 
 
 
 
d) acknowledge staff input and opinions 
 
 
 
 
 
 
 
14. Communication would be maintained 
through: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) regular project meetings with the project 
champion and team members 
 
 
 
 
 
 
b) involvement of quality management staff in 
project planning and implementation 
 
 
 
 
 
 
c) regular feedback to clinical management on 
progress of project activities and resource 
needs 
 
 
 
 
 
 
d) regular feedback to clinicians on effects of 
practice changes on patient care/outcomes 
 
 
 
 
 
 
 
 
 

Alliance A231601CD 
79 
Version Date: 09/16/2021 
Update #04 
15. Progress of the project would be measured 
by: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) collecting feedback from patients regarding 
proposed/implemented changes 
 
 
 
 
 
 
b) collecting feedback from staff regarding 
proposed/implemented changes 
 
 
 
 
 
 
c) developing and distributing regular 
performance measures to clinical staff 
 
 
 
 
 
 
d) providing a forum for 
presentation/discussion of results and 
implications for continued improvements 
 
 
 
 
 
 
 
16. The following would be available to make the 
selected plan work: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) staff incentives 
 
 
 
 
 
 
b) equipment and materials 
 
 
 
 
 
 
c) patient awareness/need 
 
 
 
 
 
 
d) provider buy-in 
 
 
 
 
 
 
e) intervention team 
 
 
 
 
 
 
f) evaluation protocol 
 
 
 
 
 
 
 
17. Plans for evaluation and improvement of this 
intervention would include: 
Strongly 
Disagree 
Disagree 
Neither 
Agree or 
Disagree 
Agree 
Strongly 
Agree 
Don’t 
Know/Not 
Applicable 
a) periodic outcome measurement 
 
 
 
 
 
 
b) staff participation satisfaction survey 
 
 
 
 
 
 
c) patient satisfaction survey 
 
 
 
 
 
 
d) dissemination of plan for performance 
measures 
 
 
 
 
 
 
e) review of results by clinical leadership 
 
 
 
 
 
 
 
 
 

Alliance A231601CD 
80 
Version Date: 09/16/2021 
Update #04 
PART IV. About You 
18. What is your role? 
 
Surgeon 
 
 
Nurse Practitioner 
 
 
Nurse 
 
 
Physician Assistant 
 
 
Other, please specify: 
 
 
 
 
19. How many years have you been with your current organization? _________ years  
 
 
THANK YOU!