Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient Population
Phase: NA
Conditions: Pain
Sponsor: Weill Medical College of Cornell University

“Adaptation of Ca-HELP Intervention in Rural Geriatric Cancer Patient 
Population” 
NCT04262232 
Document date: April 19, 2019 

Page # i 
TITLE:  Ca-HELP Intervention in Rural Geriatric Cancer Patient Population 
IRB Protocol #: 19-04020220 
Version Date: April 19, 2019 
Funding Source(s): (if applicable):   National Institutes of Health 
Multiple-Principal Investigator (WCM): 
Megan Shen, PhD 
420 East 70th St. 3rd Floor, Suite B 
phone: (646) 962-7142 
fax: (646) 962-0812 
mes2050@med.cornell.edu 
Multiple-Principal Investigator (Planetree): Jill Harrison, PhD 
Planetree 
130 Division St. 
Derby, CT, 06418 
phone: (919) 536-8715  
jharrison@planetree.org 
Co-Investigators (WCM): 
Cary Reid, MD, PhD 
525 E. 68th St., 14th Floor, Box 39 
phone: (212) 746-1378 
fax: (212) 746-4888 
mcr2004@med.cornell.edu 
Co-Investigators (Maury): 
Tammy Stokes, BSN, CHPN, RN 
Maury Regional Medical Center 
1224 Trotwood Ave. 
Columbia, TN 38401 
phone: (931) 381-1111 ext. 4090 
E-mail address: tstokes@mauryregional.com
Statistician: 
Medical Monitor: 
Not applicable 
Not applicable 
Participating Sites:  Planetree 
Jill Harrison, PhD (Co-PI) 
Maury Regional Medical Center (Co-Investigator) 
Tammy Stokes, RN 

Protocol # 19-04020220 
Version Date: April 19, 2019 
Page # ii 
Table of Contents 
LIST OF ABBREVIATIONS................................................................................................................ IV 
1. PROTOCOL SUMMARY ................................................................................................................ 1 
1.1.1 Objectives 
3 
1.1.2 Hypotheses / Research Questions 
3 
2. BACKGROUND AND SIGNIFICANCE ............................................................................................. 3 
3. STUDY DESIGN AND METHODS ................................................................................................... 4 
3.1 Overall Design .......................................................................................................................... 4 
No participants will be recruited or enrolled at WCM, all recruitment and enrollment will be at 
Maury Regional Medical Center under their approved IRB. ........................................................ 4 
3.2 Interviews, Focus Groups, Surveys, and/or Observations ....................................................... 5 
4. STUDY DESIGN ............................................................................................................................. 6 
4.1 Study Population ...................................................................................................................... 6 
4.2 Inclusion Criteria ...................................................................................................................... 6 
4.3 Exclusion Criteria ...................................................................................................................... 6 
4.4 Strategies for Recruitment and Retention ............................................................................... 6 
5. REGISTRATION PROCEDURES ...................................................................................................... 7 
5.1 
Subject Registration (WCM only) ........................................................................................ 7 
5.2 Subject Registration (Sub-sites) ............................................................................................... 7 
6. STUDY PROCEDURES ................................................................................................................... 8 
6.1 Schedule of Assessments ......................................................................................................... 8 
7.0 DATA REPORTING / REGULATORY CONSIDERATIONS .............................................................. 9 
7.1 Data Collection ......................................................................................................................... 9 
7.1.1 REDCap 
9 
7.2 Regulatory Considerations ....................................................................................................... 9 
7.2.1 Institutional Review Board/Ethics Committee Approval 
9 
7.2.2 Ethical Conduct of the Study 
10 
7.2.3 Informed Consent 
10 
7.2.4 Compliance with Trial Registration and Results Posting Requirements 
10 
7.2.5 Record Retention 
10 
8. STATISTICAL CONSIDERATIONS ................................................................................................. 11 
9. ADVERSE EVENT REPORTING REQUIREMENTS ......................................................................... 11 
10. UNANTICIPATED PROBLEMS INVOLVING RISKS TO SUBJECTS OR OTHERS ............................ 11 
REFERENCES .................................................................................................................................. 12 

Protocol # 19-04020220 
Version Date: April 19, 2019 
Page # iii 
Confidentiality Statement 
This document is confidential and is to be distributed for review only to investigators, potential 
investigators, consultants, study staff, and applicable independent ethics committees or institutional 
review boards. The contents of this document shall not be disclosed to others without written 
authorization from WCM. 
Maury Regional Medical Center 
_________________________________________________________________ 
Institution Name 
Planetree 
_________________________________________________________________ 
Institution Name 
______________________________     ______________________________     ____________________ 
Principal Investigator’s Name  
  Principal Investigator’s Signature  
 Date 
Megan Johnson Shen, PhD
04-25-2019

Protocol # 19-04020220 
Version Date: April 19, 2019 
Page # iv 
List of Abbreviations 
AE 
Adverse Event 
Ca-HELP 
Cancer Health Empowerment for Living without Pain 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CTSC 
Clinical Translational Science Center  
DSMB 
Data Safety Monitoring Board 
DSMP 
Data Safety Monitoring Plan 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HRBFA 
Human Research Billing Analysis Form 
HUD 
Humanitarian Use Device  
ICF 
Informed Consent Form 
IDE 
Investigational Device Exemption  
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
M-PACE
Method for Program Adaptation through Community Engagement 
PHI 
Protected Health Information 
PI 
Principal Investigator 
REDCap 
Research Electronic Data Capture 
SAE 
Serious Adverse Event 
SUSAR 
Suspected Unexpected Serious Adverse Reaction  
UIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
WCM 
Weill Cornell Medicine 

Protocol # 19-04020220 
Version Date: April 19, 2019 
Page # 1 
1. Protocol Summary
Full Title: 
Ca-HELP Intervention in Rural Geriatric Cancer Patient Population 
Short Title: 
Ca-HELP Intervention  
Principal Investigator: 
Megan Shen, PhD 
Study Description:  
The proposed study will involve our multi-stakeholder team of 
researchers, patients, and rural setting healthcare providers and 
administrators to conduct critical groundwork needed to inform 
adaptation of the Ca-HELP intervention in rural settings. 
Sample Size: 
No participants will be enrolled or recruited at WCM  
Phase 1: 
Geriatric Cancer Patients: N=10 
Caregivers: N=10 
Providers: N=10 
Phase 2: 
Geriatric Cancer Patient: N=30 
Enrollment: 
No participants will be enrolled or recruited at WCM 
Phase 1:  
Geriatric Cancer Patients: Enroll 10, Screen 40 
Caregivers: Enroll 10, Screen 40 
Providers: Enroll 10, Screen 30 
Phase 2: 
Geriatric Cancer Patients: Enroll 30, Screen 110 
Study Population: 
Geriatric Cancer Patients; Caregivers of Geriatric Cancer Patients; 
Providers of Geriatric Cancer Patients 
Enrollment Period: 
Phase 1: 2 months 
Phase 2: 3 months 
Study Design: 
Phase 1: Semi-Structured qualitative feedback interview 
Phase 2: Pre-Post Intervention Study  
Description of Sites/ 
Facilities Enrolling 
Participants: 
Maury Regional Medical Center will be recruiting all participants.  WCM 
and Planetree will be analyzing the data. 
Study Duration: 
July 1, 2022 
Projected end date for the completion of the study (including data 
analysis). 
Participant Duration: 
Phase 1: 1 day 
Phase 2: 1 year 

Protocol # 19-04020220 
Version Date: April 19, 2019 
Page # 2 
Primary Objective: 
Phase 1: To adapt the Ca-HELP intervention for use with older adults 
with cancer in rural settings. This intervention adaptation will be 
informed by: (1) social-cognitive theory; (2) mixed methods analysis; 
and (3) semi-structured interviews from key stakeholder groups 
including patients, caregivers, and providers and hospital administration 
staff in rural clinic settings. 
Phase 2a: To evaluate the feasibility and acceptability of the adapted 
Ca-HELP intervention among older adults with cancer in rural clinic 
settings. 
Phase 2b: To test the preliminary efficacy of the Ca-HELP intervention 
adaptation on older adults with cancer to improve pain self-
management (primary outcome) as well as pain misconceptions; self-
efficacy to communicate with their physicians regarding pain severity, 
pain-related impairment, and pain severity (secondary outcomes). 
Secondary Objectives:  
Not applicable 
Exploratory Objectives:  
Not applicable 
Endpoints: 
All Phases: Demographics will be measured via self-report assessing: 
age, gender, race, ethnicity, marital and parental status, employment 
status, education, income, religious affiliation, and insurance coverage. 
Clinical variables will be assessed using records from medical charts and 
will include the following: cancer diagnosis and stage, treatment 
received, co-morbid conditions, and Karnofsky performance status.15 
Phase 2a: Feasibility will be assessed by accrual rates and rate of 
intervention completion. Acceptability will be assessed with Likert scale 
and a semi-structured interview assessing perceived helpfulness, 
satisfaction, usability, readability, and intervention impact. Treatment 
fidelity will be assessed with a checklist that captures whether session 
content was delivered and appropriate techniques were utilized.  
Phase 2b: Pain self-management will be measured using two items 
from the pain management subscale of the Chronic Pain Self-Efficacy 
scale.11 Pain misconceptions will be assessed using the 11 items based 
on the SBQ.16 Self-efficacy for communicating with physicians about 
pain severity will be assessed using the 5-item Perceived Efficacy in 
Patient-Physician Interactions scale17 as modified to refer to 
communication with oncologists.11 Pain-related impairment will be 
measured using the 6-item Medical Outcomes Study (MOS) Pain 
Impairment Scale.18 Pain severity will be assessed as the mean of the 
average and worst pain over the past two weeks on a 0 to 10 scale (0 = 
no pain and 10 = worst pain imaginable).11  

Protocol # 19-04020220 
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Page # 3 
 1.1 Study Objectives 
1.1.1 Objectives 
Phase 1: To adapt the Ca-HELP intervention for use with older adults with cancer in rural 
settings. This intervention adaptation will be informed by: (1) social-cognitive theory;12,13 (2) 
mixed methods analysis; and (3) semi-structured interviews from key stakeholder groups 
including patients, caregivers, and providers and hospital administration staff in rural clinic 
settings. 
Phase 2a: To evaluate the feasibility and acceptability of the adapted Ca-HELP intervention 
among older adults with cancer in rural clinic settings. 
Phase 2b: To test the preliminary efficacy of the Ca-HELP intervention adaptation on older 
adults with cancer to improve pain self-management (primary outcome) as well as pain 
misconceptions; self-efficacy to communicate with their physicians regarding pain severity, pain-
related impairment, and pain severity (secondary outcomes). 
1.1.2 Hypotheses / Research Questions 
Hypothesis Phase 2a: To evaluate feasibility, ≥70% of participants will meet the benchmark for 
feasibility defined by participant retention and adherence to the intervention.  
Hypothesis Phase 2b: To evaluate acceptability, ≥70% of participants will meet the benchmark 
for acceptability defined by responses on self-report measures of perceived helpfulness, 
satisfaction, and impact. 
Hypothesis Phase 2c: We hypothesize that the intervention will reduce patients’ pain 
misconceptions, pain-related impairment, and pain severity and improve pain self-management 
and self-efficacy to communicate about pain with their physicians. 
2. Background and Significance
Effective pain management is one of the largest population health problems among older adults in the
U.S.1-8 Older adults living in rural areas are disproportionately affected due to the following factors: less
access to care,4 patients’ concerns around the over-use of pain medication,3 and patients’ preferences for
non-pharmacological interventions.6 Among the growing older adult population in the U.S.—under
treated cancer pain is very common. 7,9 There is an urgent need for pain management interventions
that can be implemented effectively among these vulnerable communities.
The Cancer Health Empowerment for Living without Pain (Ca-HELP) is an evidence-based communication
tool that empowers and engages patients to communicate effectively with their physicians about
pain.10,11 The Ca-HELP intervention is rooted in social-cognitive theory12,13 which posits that behavior
change and maintenance depends largely on individuals’ ability and self-efficacy to execute a specific
behavior. Ca-HELP coaches patients to ask questions, make requests, and signal distress to their
physicians in order to achieve improved pain control. Previous research indicates significant
improvement among cancer patients in their self-efficacy to communicate about their pain to their
oncologists and reductions in pain misconceptions and pain-related impairment.11 Although a promising
tool among geriatric cancer patients, Ca-HELP is not currently designed for optimal dissemination in rural
settings.

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3. Study Design and Methods
3.1 Overall Design
No participants will be recruited or enrolled at WCM, all recruitment and enrollment will be at 
Maury Regional Medical Center under their approved IRB. 
Phase 1: Patients, caregivers, and providers will first provide informed consent. Next, we will 
provide participants with drafts of intervention workbook content to review.  We will then conduct 
semi-structured qualitative interviews in-person or over the telephone with 10 geriatric cancer 
patients, 10 informal caregivers, and 10 providers in which they will answer questions about how 
they might use the intervention workbooks, the clarity and readability of the workbooks, and the 
feasibility and utility of the structure of the intervention (e.g., number of sessions, session 
frequency). Additionally, participants will be probed about necessary modifications in order to make 
the Ca-HELP intervention workbook content appropriate for the geriatric cancer patient population. 
As outlined in the research strategy, this feedback will be obtained through semi-structured 
interviews, through a steering committee, and through implement the un-adapted program to 
obtain recommendations for necessary change. Patients, caregivers and providers will be 
compensated with $35.00 for their participation.  
Phase 2: Patients and caregivers will first provide informed consent and then will be administered 
pre-intervention study surveys over the telephone.  They will then participate in the intervention in 
person or over the telephone, depending on the recommended results from completion of Aim 1. 
Following intervention completion, post-intervention study surveys will be administered over the 
telephone. Study staff will extract data (e.g., disease stage, etc.) from the electronic health record.  
Patients will be compensated with $25.00 for completing pre-intervention assessments and $25.00 
for completing post-intervention assessments. 
The following steps will be taken to minimize participant burden. First, significant effort will be made 
to coordinate in-person study contacts (e.g., to provide information on the study and administer 
informed consent) with existing appointments to minimize the number of trips to Maury Region 
Medical Center required of participants. Second, with the participant’s permission, these study visits 
(for Aim 1) can be conducted during scheduled chemotherapy infusions (if applicable, as some 
cancer patients will not be receiving chemotherapy). Chemotherapy infusion appointments are 
often long (multiple hours) and patients are unable to leave the clinic during the appointment. In a 
previous R01 study (Co-I: Dr. Shen) of psychosocial distress in adults with advanced cancer, patients 
often elected to conduct research meetings during infusion appointments to provide activity during 
the appointment and reduce the overall time spent at the hospital. Prior to conducting visits during 
infusion appointments, participants will be reminded that infusion clinics are often not private and 
their permission to conduct the visit during infusion will be obtained. Participants will also be 
informed that they can discontinue at any time if they become uncomfortable due to the setting. If 
participants are not comfortable conducting visits during infusion appointments, separate 
appointments will be scheduled in person or over the telephone. Similar measures will be taken to 
reduce the burden on caregivers participating in this study and all efforts will be made to coordinate 
study visits during times when they are already at the hospital with the patient. Third, participants 
will be given the option to complete the semi-structured interviews for Aim 1 over the telephone 
and administration of all study measures for Phase 2 will occur in person or over the telephone, 
depending on patient preference. This method will eliminate the need for participants to travel to 
the clinic to complete study measures.  Finally, intervention sessions may be conducted over the 
telephone with patients, depending on the results of Phase 1 and preferences of the patient 

Protocol # 19-04020220 
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population.  Telephone delivery may allow patients to participate in the intervention without 
traveling to the clinic multiple times for intervention sessions. 
3.2 Interviews, Focus Groups, Surveys, and/or Observations  
No participants will be recruited or enrolled at WCM, all recruitment and enrollment will be at 
Maury Regional Medical Center under their approved IRB. 
A.
Administration

Timing and Frequency
Phase 1: 1 interview
Phase 2:  Pre-interview/Baseline assessment, intervention call, and post assessment
each approximately 1 week apart for a total of 3 weeks.

Location
All phases: Telephone interview at a convenient location to the participants.  Cancer
patients may opt to have their interview(s) during infusion at Maury Regional Medical
Center

Procedures For Audio And Visual Recording
Not Applicable

Person Identifiers
Clinical variables will be collected from medical records and will include the following:
cancer diagnosis and stage, treatment received, co-morbid conditions, and Karnofsky
performance status.
B. Study Instruments
All Phases: Demographics will be measured via self-report assessing: age, gender, race,
ethnicity, marital and parental status, employment status, education, income, religious
affiliation, and insurance coverage. Clinical variables will be assessed using records from
medical charts and will include the following: cancer diagnosis and stage, treatment received,
co-morbid conditions, and Karnofsky performance status.15
Phase 2a: Feasibility will be assessed by accrual rates and rate of intervention completion.
Acceptability will be assessed with Likert scale and a semi-structured interview assessing
perceived helpfulness, satisfaction, usability, readability, and intervention impact. Treatment
fidelity will be assessed with a checklist that captures whether session content was delivered
and appropriate techniques were utilized.
Phase 2b: Pain self-management will be measured using two items from the pain
management subscale of the Chronic Pain Self-Efficacy scale.11 Pain misconceptions will be
assessed using the 11 items based on the SBQ.16 Self-efficacy for communicating with
physicians about pain severity will be assessed using the 5-item Perceived Efficacy in Patient-
Physician Interactions scale17 as modified to refer to communication with oncologists.11 Pain-
related impairment will be measured using the 6-item Medical Outcomes Study (MOS) Pain
Impairment Scale.18 Pain severity will be assessed as the mean of the average and worst pain
over the past two weeks on a 0 to 10 scale (0 = no pain and 10 = worst pain imaginable).11

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4. Study Design
4.1 Study Population
Patient subjects with a cancer diagnosis who meet the inclusion and exclusion criteria will be eligible 
for this study.  Caregivers and Providers who meet the inclusion and exclusion criteria will be eligible 
for the study.  Providers will include social workers, nurses, oncologists, and healthcare 
administrators. 
4.2 Inclusion Criteria 
Patients: 
1.
65 years of age or older
2.
Diagnosed with cancer
3.
English speaking
4.
Resides in non-institutional, rural settings
5.
Receives care at a community-based clinic in a rural area
6.
Ability to provide informed consent
7.
Have an identified informal Caregiver
Caregivers: 
1.
Person (family member or friend) whom the patient indicates provides most of their
informal care
2.
Ability to provide informed consent
Providers: 
1.
Currently works with geriatric cancer patients
OR
2.
Currently works in a healthcare system serving geriatric cancer patients
4.3 Exclusion Criteria 
Patients: 
1.
Severe cognitive impairment (Short Portable Mental Status Questionnaire<6)
2.
Receiving hospice at time of enrollment
Caregivers and Providers: None 
4.4 Strategies for Recruitment and Retention 
No participants will be recruited or enrolled at WCM, all recruitment and enrollment will be at 
Maury Regional Medical Center under their approved IRB. 
A total of 40 geriatric cancer patients will be recruited across both phases once they have been 
identified by research and medical staff and confirmed to meet eligibility criteria. Based on prior 
work with cancer patient populations in rural clinic settings, we conservatively estimate that 50% of 
the approached patients (n=160) will be eligible to participate and consent to participate (n=80). 
Caregivers of these patients will then be screened for eligibility (for Phase 1).  Based on current work 
by the study team on cancer caregivers, we estimate that 50% of approached caregivers will be 
eligible and consent to participate (n=40), ensuring we hit our recruitment goal of n=10 caregivers 
for Phase 1.  Thus, in total, 40 geriatric cancer patients and 10 informal, unpaid caregivers will 
participate in this study. Finally, we seek to recruit 10 oncology providers working within rural 
settings with the geriatric cancer patient population. In prior studies, our recruitment rates of 
providers have been in line with prior provider-based studies (35-50%). Thus, we conservatively 
estimate an accrual rate of 35%.  

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To recruit patients (Phase 1 and 2): Research staff will review the electronic health record to identify 
potentially eligible patients and will contact the treating physician to confirm initial eligibility and 
obtain permission to approach these patients about the study.  Patients approved for contact by the 
treating physician will be approached in clinic or sent a letter in the mail that includes a brief 
description of the study and contact information of study staff.  Research staff will meet these 
patients in the clinic, introduce themselves, and provide the patient with a study information sheet 
and consent form. Patients who indicate they want to participate will be consented at that time or 
provided a pre-paid postmarked return envelope in which to return the consent form and contacted 
within one week via telephone for follow-up. Patients who study staff are unable to meet during 
clinic appointments will be contacted by study staff over the telephone and will be provided with 
information on the study and administered informed consent.  Once consented, participants will be 
enrolled in the study.  
To recruit caregivers (Phase 1 only): After an eligible patient agrees to participate, we will approach 
his/her designated informal caregiver to participate as well. If the caregiver is present during the 
patient’s clinic appointment, study information will be provided at that time.  If the caregiver is not 
present, study staff will contact the caregiver over the telephone.  We will provide caregivers with 
information about the study, address any questions or concerns they may have, obtain consent for 
participation, and enroll them in the study.  
To recruit providers (Phase 1 only): The MPIs will send an introductory email to providers working 
the participating site (Maury Regional Medical Center) as well as listservs of professional societies 
and networks of study team members requesting that interested providers contact the study team 
who meet inclusion criteria (i.e., working with geriatric cancer patients in rural clinic settings).  
Providers who express interest will be contacted by the team and provided with information about 
the project and its potential risks and benefits.  Providers who indicate an interest in participating 
will be consented.  
Phase 1 participants will be compensated $35.00 for their participation.  Phase 2 participants will be 
compensated $25.00 for completing pre-intervention assessments and $25.00 for completing post-
intervention assessments. 
5. Registration Procedures
5.1 Subject Registration (WCM only) 
Subjects will be not be registered within the WRG-CT as per the standard operating procedure 
for Subject Registration because subject enrollment will be at and under the IRB of Maury 
Regional Medical Center. 
5.2 Subject Registration (Sub-sites) 
Not applicable 

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6. Study Procedures
6.1 Schedule of Assessments
Table 1. Schedule of trial events 
Phase 1 
Phase 2 
All Phases 
Pre-
Study 
Visit 1 
Pre-
Study 
Wk
1 
Wk
2 
Wk
3 
Off Study 
Informed consent 
X 
X 
Review of Intervention Draft 
X 
Qualitative Interview 
X 
Demographics 
X 
X 
Clinical Variables 
X 
Intervention 
X 
Feasibility 
X 
X 
Feasibility 
X 
X 
Treatment Fidelity 
X 
X 
Pain Self-Management 
X 
X 
Pain Misconceptions 
X 
X 
Self-efficacy for communicating  
w/physicians about pain severity 
X 
X 
Pain-Related Impairment 
X 
X 
Pain Severity 
X 
X 
Intervention 
X 

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7.0 Data Reporting / Regulatory Considerations 
7.1 Data Collection 
Data will be collected and stored at Maury, on their secured servers on password protected 
computers under their IRB protection. Only de-identified data will be shared with Planetree and 
WCM, and will not include PHI or MRNs. etc.  All data will be stored on secure servers on 
password protected computers.  Only IRB approved study staff will have access to these data. 
7.1.1 REDCap 
Not Applicable 
7.2 Regulatory Considerations 
7.2.1 Institutional Review Board/Ethics Committee Approval  
As required by local regulations, the Investigator will ensure all legal aspects are covered, and 
approval of the appropriate regulatory bodies obtained, before study initiation.  
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the patients, and any other relevant study documentation will be submitted to the 
appropriate Ethics Committee. Written approval of the study and all relevant study information 
must be obtained before the study center can be initiated or the IP is released to the Investigator. 
Any necessary extensions or renewals of IEC/IRB approval must be obtained for changes to the 
study, such as amendments to the protocol, the ICF, or other study documentation. The written 
approval of the IEC/IRB together with the approved ICF must be filed in the study files.  
The Investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The Investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the IEC/IRB 
will be notified that the study has ended.  
Neither the Investigator nor BMS will modify or alter this protocol without the agreement of the 
other. All agreed protocol amendments will be clearly recorded on a protocol amendment form 
and will be signed and dated by the original protocol approving signatories. All protocol 
amendments will be submitted to the relevant institutional IEC/IRB for approval before 
implementation, as required by local regulations. The only exception will be when the 
amendment is necessary to eliminate an immediate hazard to the trial participants. In this case, 
the necessary action will be taken first, with the relevant protocol amendment following shortly 
thereafter.  
Once protocol amendments or consent form modifications are implemented at the lead site, Weill 
Cornell Medicine, updated documents will be provided to participating sites. Weill Cornell 
Medicine must approve all consent form changes prior to local IRB submission.  
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.  

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7.2.2 Ethical Conduct of the Study 
The Investigators and all parties involved should conduct this study in adherence to the ethical 
principles based on the Declaration of Helsinki, GCP, ICH guidelines and the applicable national 
and local laws and regulatory requirements.  
This study will be conducted under a protocol reviewed and approved by the applicable ethics 
committees and investigations will be undertaken by scientifically and medically qualified 
persons, where the benefits of the study are in proportion to the risks. 
7.2.3 Informed Consent 
The investigator or qualified designee must obtain documented consent according to ICH-GCP 
and local regulations, as applicable, from each potential subject or each subject’s legally 
authorized representative prior to participating in the research study. Subjects who agree to 
participate will sign the approved informed consent form and will be provided a copy of the signed 
document.   
The initial ICF, any subsequent revised written ICF and any written information provided to the 
subject must approved by IRB prior to use. The ICF will adhere to IRB/IEC requirements, applicable 
laws and regulations. 
Informed Consent will occur under the IRB of Maury Regional Medical Center. 
7.2.4 Compliance with Trial Registration and Results Posting Requirements  
Under the terms of the Food and Drug Administration Modernization Act (FDAMA) and the Food 
and Drug Administration Amendments Act (FDAAA), the Sponsor-Investigator of the trial is solely 
responsible for determining whether the trial and its results are subject to the requirements for 
submission to http://www.clinicaltrials.gov. Information posted will allow subjects to identify 
potentially appropriate trials for their disease conditions and pursue participation by calling a 
central contact number for further information on appropriate trial locations and trial site contact 
information. 
7.2.5 Record Retention 
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced.  After completion of the study, all documents and 
data relating to the study will be kept in an orderly manner by the Investigator in a secure study 
file.  Essential documents should be retained for 2 years after the final marketing approval in an 
ICH region or for at least 2 years since the discontinuation of clinical development of the IP. In 
addition, all subject medical records and other source documentation will be kept for the 
maximum time permitted by the hospital, institution, or medical practice.   

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8. Statistical Considerations
We will employ thematic analysis using an iterative process for all qualitative analyses.19-23
Phase 1. Data coding and analysis will be informed by a responsive interviewing model in which data
units are combined based on the theme they represent.24 Trained raters will independently review the
transcripts and identify passages that include suggestions for modifications to the intervention. Raters
will categorize and discuss themes, and make revisions until consensus is reached. Identified themes will
inform modifications to the intervention. Phase 2a. Feasibility and acceptability will be examined by
conducting frequency and descriptive statistics (i.e., mean, median, standard deviation, range) for
enrollment rates, number of sessions completed, number of weeks required to complete the
intervention, and Likert-scale items assessing satisfaction with the intervention and perceived
helpfulness. Phase 2b. Aim 3 will be addressed using a pre-post design. To determine the degree to
which the Ca-HELP intervention is likely to improve patient outcomes, a post-versus-pre- difference will
be sought to estimate the change in patients’ outcomes (e.g, pain self-management). Missing data. To
reduce missing data, study staff will conduct interviews rather than relying on written self-reports. All
missing data will be assessed for missingness (e.g., random or non-random) and appropriate imputation
methods will be used.
9. Adverse Event Reporting Requirements
Not Applicable – No subjects will be enrolled at WCM.
10. Unanticipated Problems Involving Risks to Subjects or Others
Not Applicable – No subjects will be enrolled at WCM

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References 
1.
Reid MC, Papaleontiou M, Ong A, Breckman R, Wethington E, Pillemer K. Self-management
strategies to reduce pain and improve function among older adults in community settings: a review of
the evidence. Pain Medicine. 2008;9(4):409-424.
2.
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