A Randomized Trial of the Altering Intake, Managing Symptoms Intervention for Bowel Dysfunction in Rectal Cancer Survivors Compared to a Healthy Living Education Control: A Feasibility and Preliminary Efficacy Study (AIMS-RC)
Phase: PHASE2
Conditions: Rectal Carcinoma, Rectosigmoid Carcinoma
Sponsor: SWOG Cancer Research Network

 
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PRIVILEGED COMMUNICATION 
 
FOR INVESTIGATIONAL USE ONLY 
 
 
SWOG CANCER RESEARCH NETWORK 
TITLE 
A RANDOMIZED TRIAL OF THE ALTERING INTAKE, MANAGING SYMPTOMS 
INTERVENTION FOR BOWEL DYSFUNCTION IN RECTAL CANCER SURVIVORS COMPARED TO A 
HEALTHY LIVING EDUCATION CONTROL: A FEASIBILITY AND PRELIMINARY EFFICACY STUDY 
(AIMS-RC) 
 
NCT# 04205955 
 
STUDY CHAIR: 
Virginia Sun, Ph.D., R.N (Nursing Science) 
City of Hope 
1500 East Duarte Road 
Duarte, CA 91010 
Phone: 626/218-3122 
FAX: 626/218-8941 
E-mail: vsun@coh.org 
 
CO-CHAIRS: 
Cynthia A. Thomson, Ph.D., RDN (Nutrition 
Science) 
University of Arizona Cancer Ctr 
3950 S. Country Club, Suite 330 
Tucson, AZ 85714 
Phone: 520/626-1565 
FAX: 520/626-6600 
E-mail: cthomson@email.arizona.edu 
 
Tracy E. Crane, Ph.D., RDN (Nutrition Science) 
Sylvester Comprehensive Cancer Center 
1475 NW 12th Ave 
Miami, FL 33136 
Phone:  305/243-8255 
FAX: 305/243-0424 
E-mail: tecrane@med.miami.edu  
 
Robert S. Krouse, MD (Surgery) 
University of Pennsylvania 
Department of Surgery  
3400 Spruce St., 4 Silverstein   
 
Philadelphia, PA 19104  
 
Phone: 215/662-2015 
Fax: 215/615-0901 
Email: 
Robert.krouse@pennmedicine.upenn.edu 
BIOSTATISTICIANS: 
Katherine A. Guthrie, Ph.D. (Biostatistics) 
Kathryn B. Arnold, M.S (Biostatistics) 
SWOG Statistics and Data Management Center 
Fred Hutchinson Cancer Research Center 
1100 Fairview Avenue N, M3-C102 
P.O. Box 19024 
Seattle, WA 98109-1024 
 
Phone: 206/667-4623 
FAX: 206/667-4408 
E-mail: kguthrie@fredhutch.org 
E-mail: karnold@fredhutch.org 
 
NURSE COORDINATOR: 
Christa Braun-Inglis, APRN, FNP-BC, AOCNP  
University of Hawaii Cancer Center 
701 Ilalo Street, Room 320 
Honolulu, HI 96813 
Phone: 808/440-5213 
FAX: 808/586-3016 
Email: CBraunInglis@cc.hawaii.edu 
 
PATIENT ADVOCATES: 
Lee Jones 
Florence Kurttila 
 
GI COMMITTEE CHAMPIONS: 
Mazin Al-Kasspooles, MD (Surgery) 
University of Kansas 
 
 
Stacey Cohen, MD (Medical Oncology) 
University of Washington 
 
 
 

 
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PARTICIPANTS 
 
 
U.S.-Only Participants: 
 
ALLIANCE/Alliance for Clinical Trials in Oncology 
ECOG-ACRIN/ECOG-ACRIN Cancer Research Group 
NRG/NRG Oncology 
SWOG/SWOG Cancer Research Network 
 
 
 
 
 
 
 
 
 

 
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TABLE OF CONTENTS 
TITLE  ............................................................................................................................................ 1 
PARTICIPANTS ............................................................................................................................... 2 
TABLE OF CONTENTS .................................................................................................................. 3 
PROTOCOL CONTACT INFORMATION ........................................................................................ 5 
CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION .......... 6 
SCHEMA .......................................................................................................................................... 7 
1.0 
OBJECTIVES ..................................................................................................................... 8 
1.1 
Primary Objective ................................................................................................................ 8 
1.2 
Exploratory Objective(s) ...................................................................................................... 8 
2.0 
BACKGROUND .................................................................................................................. 8 
3.0 
DRUG INFORMATION ..................................................................................................... 11 
4.0 
STAGING CRITERIA ........................................................................................................ 11 
5.0 
ELIGIBILITY CRITERIA ................................................................................................... 11 
5.1 
Disease Related Criteria ................................................................................................... 12 
5.2 
Prior/Concurrent Therapy Criteria ..................................................................................... 12 
5.3 
Clinical/Laboratory Criteria ................................................................................................ 12 
5.4 
Clinical/Laboratory Criteria ................................................................................................ 12 
5.5 
Regulatory Criteria ............................................................................................................ 13 
6.0 
STRATIFICATION FACTORS .......................................................................................... 13 
7.0 
STUDY PROCEDURES ................................................................................................... 13 
7.1 
Communication Between Study Sites and University of Arizona: .................................... 13 
7.2 
Study Flow Diagram .......................................................................................................... 14 
7.3 
Run-In Period .................................................................................................................... 15 
7.4 
Bowel Symptom Management Assessment ..................................................................... 17 
7.5  
Arm 1:  Intervention Arm (AIMS-RC) ................................................................................ 17 
7.6 
Arm 2:  Attention Control Arm ........................................................................................... 19 
7.7 
Assessment Telephone Calls ........................................................................................... 20 
7.8 
Criteria for Removal from Protocol Intervention ................................................................ 20 
7.9 
Discontinuation of Protocol Intervention ........................................................................... 20 
7.10 
Follow-Up Period ............................................................................................................... 21 
8.0 
TOXICITIES TO BE MONITORED AND DOSE MODIFICATIONS ................................. 21 
9.0 
STUDY CALENDAR ......................................................................................................... 22 
10.0 
CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS ........................................ 24 
10.1 
Primary Endpoint ............................................................................................................... 24 
10.2 
Exploratory Endpoints ....................................................................................................... 24 
11.0 
STATISTICAL CONSIDERATIONS ................................................................................. 26 
11.1 
Primary Endpoint and Sample Size .................................................................................. 26 
11.2 
Primary Endpoint Analyses ............................................................................................... 26 
11.3 
Other Analyses .................................................................................................................. 26 
11.4 
Accrual .............................................................................................................................. 27 
11.5 
Data and Safety Monitoring .............................................................................................. 27 
12.0 
DISCIPLINE REVIEW ....................................................................................................... 27 
13.0 
REGISTRATION GUIDELINES ........................................................................................ 27 
13.1 
Registration Timing ........................................................................................................... 27 
13.2 
CTEP Investigator Registration Procedures ..................................................................... 28 
13.3 
OPEN Registration Requirements .................................................................................... 31 
13.4 
Registration Procedures ................................................................................................... 32 
13.5 
Exceptions to SWOG registration policies will not be permitted. ...................................... 32 
14.0 
DATA SUBMISSION SCHEDULE ................................................................................... 32 
14.1 
Data Submission Requirement ......................................................................................... 32 
14.2 
Master Forms .................................................................................................................... 33 
14.3 
Data Submission Procedures ........................................................................................... 33 
14.4 
Data Submission Overview and Timepoints ..................................................................... 33 
15.0 
SPECIAL INSTRUCTIONS .............................................................................................. 37 
15.1 
Administration of Questionnaires to Patients .................................................................... 37 
15.2 
Additional Quality Control Procedures .............................................................................. 39 
16.0 
ETHICAL AND REGULATORY CONSIDERATIONS ...................................................... 40 

 
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17.0 
BIBLIOGRAPHY ............................................................................................................... 41 
18.0 
APPENDIX ........................................................................................................................ 48 
18.1 
American Joint Committee on Cancer 2010 Staging System, 8th Edition ......................... 49 
18.2 
AIMS-RC Intervention Sessions ....................................................................................... 50 
18.3  
General Study Description – Overview ............................................................................. 52 
18.4 
University of Arizona-Directed Data Collection ................................................................. 53 
18.5 
Allowances during COVID-19 pandemic........................................................................... 54 
18.6  
Procedures for Remote Consent ...................................................................................... 55 
 

 
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PROTOCOL CONTACT INFORMATION 
 
Eligibility, RAVE, Data Submission: 
SWOG Statistics and Data Management Center  
E-mail: cancercontrolquestion@crab.org  
or Phone: 206/652-2267 
Regulatory, Protocol, Informed Consent: 
SWOG Operations Office 
E-mail: protocols@swog.org or Phone: 210/614-8808 
 
Clinical-Related Questions 
Email: vsun@coh.org    
or call: 
Virginia Sun, Ph.D., R.N at: Office Phone: 626/218-
3122; Cell Phone: 626-257-4717 
 
Training-Related Questions 
Email: cbrauninglis@cc.hawaii.edu 
Or call:  
Christa Braun-Inglis  
Office Phone: 808-440-5213 
 
Amendments, Errors, Connectivity Issues 
and Technical issues with the SWOG CRA 
Workbench: 
technicalquestion@crab.org 
Cancer Therapy and Evaluation Program - 
Identity and Access Management (CTEP-
IAM) 
To review CTEP-IAM account (new requests, reset 
passwords): 
https://ctepcore.nci.nih.gov/iam/index.jsp 
Access to Medidata Rave 
See Protocol Section 14.3 or contact  
CTSU Help Desk:  
Phone: 1-888-823-5923  
or Email: ctsucontact@westat.com 
Questions related to: 
Oncology Participant Enrollment Network 
(OPEN) 
See Protocol Section 13.3 or contact  
CTSU Help Desk:  
Phone: 1-888-823-5923 or Email: 
ctsucontact@westat.com 
Participant Transfers: 
patienttransfer@crab.org 
 
 
 

 
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CANCER TRIALS SUPPORT UNIT (CTSU) ADDRESS AND CONTACT INFORMATION 
CONTACT INFORMATION 
For regulatory requirements: 
For patient enrollments: 
For study data submission: 
Regulatory documentation must 
be submitted to the CTSU via 
the Regulatory Submission 
Portal: 
 
(Sign in at www.ctsu.org, and 
select the Regulatory 
Submission sub-tab under the 
Regulatory tab.)  
 
Institutions with patients waiting 
that are unable to use the Portal 
should alert the CTSU 
Regulatory Office immediately 
at 866-651-2878 to receive 
further information and support.   
 
Contact the CTSU Regulatory 
Help Desk at 866-651-2878 for 
regulatory assistance. 
 
Please refer to the patient 
enrollment section of the protocol 
for instructions on using the 
Oncology Patient Enrollment 
Network (OPEN) which can be 
accessed at 
https://www.ctsu.org/OPEN_SYS
TEM/ or https://OPEN.ctsu.org. 
 
Contact the CTSU Help Desk with 
any OPEN-related questions at 
ctsucontact@westat.com. 
 
Data collection for this study will 
be done exclusively through 
Medidata RAVE®.  Please see 
the data submission section of 
the protocol for further 
instructions.  
 
Other Tools and Reports: 
Institutions participating through 
the CTSU continue to have 
access to other tools and reports 
available on the SWOG 
Workbench via the SWOG 
website (www.swog.org). 
  
The most current version of the study protocol and all supporting documents must be downloaded 
from the protocol-specific Web page of the CTSU Member Web site located at https://www.ctsu.org.  
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 user log on 
with CTEP-IAM username and password.  
For patient eligibility or data submission questions contact the SWOG Statistics and Data 
Management Center (SDMC) by phone or email: 
206/652-2267 
cancercontrolquestion@crab.org 
 
For study-related questions, please contact the Study Chair at 626/218-3122, 626/257-4717, 
vsun@coh.org  
 
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: 
1-888-823-5923 
ctsucontact@westat.com.   
 
All calls and correspondence will be triaged to the appropriate CTSU representative.  
The CTSU Website is located at https://www.ctsu.org. 
 
 
 

 
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SCHEMA 
 
 
 
 
 
Approved NCTN, NCORP, and MU-NCORP Recruitment Sites 
STEP 2 REGISTRATION 
RANDOMIZATION 
Week 18 post-randomization data collection 
Arm 1 (Intervention) 
Telephone Diet Modification Coaching 
(AIMS-RC) 
Arm 2 (Attention Control) 
Telephone Health Education 
 
STEP 1 REGISTRATION  
RUN-IN  
Week 26 post-randomization data collection 

 
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1.0 
OBJECTIVES 
 
1.1 
Primary Objective 
 
a. 
To compare total bowel function score, as measured by the Memorial Sloan-
Kettering Cancer Center Bowel Function Instrument (BFI), at 18 weeks post-
randomization between the intervention and attention control arms. 
 
1.2 
Exploratory Objective(s) 
 
a. 
To compare total bowel function score at 26 weeks post-randomization between 
the intervention and attention control arms. 
 
b. 
To compare bowel function subscale scores (dietary, urgency, frequency), as 
measured by the BFI at both 18 and 26 weeks post-randomization between the 
intervention and attention control arms. 
 
c. 
To compare lower anterior resection syndrome (LARS) scores (for anastomosis 
participants only), quality of life, and dietary quality at both 18 and 26 weeks post-
randomization between the intervention and attention control arms. 
 
d. 
To compare motivation, self-efficacy, and positive/negative affect at both 18 and 
26 weeks post-randomization between the intervention and attention control arms. 
 
e. 
To assess study feasibility, adherence, retention, and acceptability at both 18 
and 26 weeks post-randomization.  
 
f. 
To explore variation in primary and exploratory study outcomes according to sex, 
and to investigate whether intervention effects on the primary outcome differ 
across subgroups defined by sex.    
 
 
2.0 
BACKGROUND 
 
Combination therapy (surgery/chemotherapy/radiation) has significantly improved long-term 
survival for men and women with rectal cancer.1, 2 However, cancer survival brings common and 
feared treatment-related side effects such as irreversible bowel dysfunction. Bowel dysfunction is 
associated with frequent and erratic bowel movements, fecal incontinence, soiling, gas, bloating, 
and oscillations between diarrhea and constipation. Our previous observational research have 
found that bowel dysfunction occurs regardless of the type of surgery and ostomy status (with or 
without a permanent ostomy), and results in reduced social activities, poor social well-being, and 
decrements in quality of life (QOL).3-7 Additionally, bowel dysfunction is a significant barrier to 
survivor adoption of dietary guidelines for cancer survivorship.8,9 
 
One promising approach for bowel symptom control is diet modifications. In our previous research 
(N=1,057), diet modification was the most consistently reported self-care strategy used by long-
term (>5 years) rectal cancer survivors.3 The ability to successfully manage bowel symptoms 
results in improved QOL; however, the choice of diet modifications varied tremendously, and was 
often based on a trial-and-error approach without structured coaching that is grounded in theory-
based strategies. This resulted in inconsistent efficacy, unnecessary delays in symptom 
improvement and, for some, avoidance of cancer preventive foods for health promotion after 
cancer.3 While registered dietitian nutritionists (RDNs) provide the expertise to meet this challenge, 
evidence shows that even in comprehensive cancer centers RDN services are not readily available. 
Current patient-to-RDN ratios exceed 1000:1.10, 11 Alternative, scalable approaches are essential 
to meet the growing demand. 
 
 

 
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Rectal Cancer as a Unique Cancer Diagnosis. Nearly 1.2 million individuals are living with a 
history of colorectal cancer in the United States; it is the third largest cancer survivorship 
population.2 Approximately 68% of individuals with a history of rectal cancer are long-term (> 5 
years) survivors.2, 12 The proportion of rectal cancer diagnosed in adults ≤ 55 years doubled from 
14.6% to 29.5% in the last 40 years.13 The observed rise of rectal cancer in younger populations is 
likely partially fueled by lifestyle factors, including obesity and diet quality.14 Rectal cancer has been 
largely ignored in terms of evaluation and symptom management, secondary to combining colon 
and rectal cancer statistics, despite highly different etiologies, treatments, symptoms and survival 
trajectories.15  
 
QOL in rectal cancer survivors is influenced by treatment, which involves the sequenced 
combination of chemotherapy, radiotherapy, and surgery. The two most common surgical 
procedures include 1) abdominoperineal resection (APR), a resection of the rectum/anus with the 
creation of a permanent ostomy; and 2) low anterior resection (LAR) with rectal anastomosis 
(rejoining of healthy ends of the bowel).16 For ease, we refer to the two techniques as “permanent 
ostomy” or “anastomosis, respectively. In 90% of survivors who undergo low-mid rectum resection, 
an anastomosis is accompanied by a temporary (“protective”) diverting ileostomy.17  
 
Bowel Function as a Driver of QOL. Bowel dysfunction is one of the most common and feared 
long-term symptoms of rectal cancer treatment. 18-23 For anastomosis patients, the term “anterior 
resection syndrome” describes the constellation of postoperative bowel symptoms; these include 
fecal incontinence, frequency, urgency, sense of incomplete fecal evacuation, and flatulence.24-27 
Bowel dysfunction significantly affect QOL in rectal cancer survivors.28-32 Our previous 
observational research suggests that bowel control varies greatly, and that 27% to 56% of survivors 
report moderate to severe bowel dysfunction at 1-year post-treatment.33-38 Consequently, rectal 
cancer survivors must adjust psychologically and behaviorally to bowel dysfunction. Importantly, 
bowel symptoms are modifiable, underscoring the need to identify and test interventions that 
contribute to symptom relief.  
 
Empirically-based interventions to manage bowel dysfunction are lacking. The American Cancer 
Society Colorectal Cancer Survivorship guidelines categorized the evidence for bowel dysfunction 
interventions at the lowest level (case studies or reports only).39 In the absence of evidence-based 
interventions, survivors use trial-and-error self-care strategies to manage bowel symptoms. 
Functional self-care strategies include diet modifications, medications/supplements, and protective 
pads/diapers.40 Social activity alterations (e.g. scheduling social outings around bowel patterns, 
intentional isolation) are often used to avoid bowel accidents in public.41  
 
Dietary Modification as a Scalable, Empirically-Based Approach for Bowel Symptom 
Management. Diet modifications are one of the most common self-care strategies to manage 
bowel symptoms.42-44 Beyond symptom management, a healthy diet is associated with decreased 
recurrence and improved survival after rectal cancer.45-47 Specifically, cancer survivors are advised 
to eat a plant-based diet, avoid red and processed meats, consume adequate fiber (25-30 grams), 
limit animal fat intake, and moderate or no alcohol consumption.9 Yet, current dietary guidance for 
cancer survivorship may be difficult to achieve in symptomatic rectal cancer patients. Survivors 
often avoid foods, including vegetables, fruits and whole grains, because of a perceived risk of 
bowel problems.3  Behavioral approaches in the context of cancer survivorship should consider 
promotion of healthy eating behaviors to enhance QOL and survivorship, while concurrently 
identifying and addressing barriers to adoption of such eating patterns. For rectal cancer survivors 
this should include the modification of food selections that impact bowel symptoms. Left on their 
own, survivors may select approaches that delay symptom resolution and/or reduce their diet 
quality.  
 
While professional dietetic services would be one solution to support bowel symptom management, 
recent reports describe the dearth of available registered dietitian nutritionists (RDN) and nutrition 
services available to survivors, even at comprehensive cancer centers.10 Furthermore, bowel 
symptom characteristics are dynamic in terms of frequency and severity, suggesting that effective 
interventions will need to be flexible in meeting individual needs. Clinic-based counseling that 

 
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requires on-site appointments, travel, with limited time availability, increases barriers to access for 
rectal cancer survivors.11 Less burdensome approaches are needed.  
 
Sex-Specific Differences in Telephone-Based Lifestyle Behavior Interventions. Although 
behavior change remains a challenge for all cancer survivors, the current literature suggest that 
men may respond differently to lifestyle behavior interventions compared to women.48 Reasons for 
these differences include 1) misperception of the need for behavior change49; 2) lack of reporting 
of attempts to change behaviors50; 3) lack of interest in undertaking behavior change51; and 4) 
perception that behavior change interventions are unappealing or designed to meet the needs of 
women.52 Current evidence suggesting sex-specific variance in telephonic and/or multimodal 
behavioral counseling in cancer survivorship is limited.  
 
Motivational Interviewing-Based Interventions for Cancer Symptom Management and 
Lifestyle Behaviors. Motivational interviewing (MI) is a patient-centered approach to facilitate 
behavior change.53 MI is widely used to address a variety of behavioral targets, with demonstrated 
success in diet, smoking cessation, exercise and other health behaviors. A recent systematic 
review by Spencer and Wheeler evaluated the effectiveness of MI for lifestyle behavior change in 
cancer patients; the review concluded that MI was successful in enhancing healthy diet behaviors, 
such as increasing the number of servings of fruits and vegetables, including RC survivors.54 MI 
was also successful in managing cancer symptoms, such as fatigue, pain, distress, and 
lymphedema.55-58    
 
Despite the current evidence that supports the efficacy of MI-based interventions, cancer survivors 
continue to struggle with healthy behaviors and symptom management. Approaches that are 
grounded in new and existing knowledge is needed. A novel method of combining skills training 
and motivational strategies is the Motivation and Problem Solving (MAPS) approach. MAPS 
incorporate social cognitive strategies (coping and problem-solving skills) within an overarching MI 
framework. Its innovation lies in a design that considers all individuals regardless of their readiness 
for behavior change. Instead of conceptualizing behavior change as phases and stages, MAPS is 
novel in conceptualizing motivation for behavior change as contextual, fluid, and dynamically 
fluctuating in a moment to moment basis.59 MAPS was initially developed for substance abuse and 
tobacco dependence, and has been demonstrated to be effective in RCTs of smoking cessation.59  
 
Rationale: Recent trends suggest that rates of rectal cancer are increasing, particularly in adults 
≤55 years.13 These trends suggest that the number of younger rectal cancer survivors living with 
bowel dysfunction will continue to rise in years to come. Furthermore, significant QOL issues are 
associated with bowel symptoms after rectal cancer treatment and there is a lack of evidence-
based interventions to support symptom management concurrent with achievement of dietary 
survivorship guidance. Current evidence suggests that cancer survivors fall short in achieving 
national survivorship diet guidelines.8 These trends will continue, unless effective interventions are 
developed, tested, and disseminated. There is also a lack of empirical data on sex-specific 
differences in behavioral intervention uptake and response. Importantly, this trial will explore 
efficacy by sex, affording opportunities to tailor the intervention as justified by the sex-specific data 
collected. Finally, there is a need to develop approaches that are scalable to a larger number of 
cancer survivors.  
 
Preliminary Work:  As the foundation of this trial we assessed survivors’ dietary and behavioral 
modifications for bowel control in two cohorts of rectal cancer survivors (N=919).3 Diet modifications 
were common, regardless of ostomy status (40.5% ostomy, 42.7% anastomosis). Most survivors 
report some reduction in symptoms over 12 months. Some never reported symptom resolution 
(18.9% ostomy, 11.3% anastomosis). Lack of symptom resolution was associated with lower QOL 
(p<.0001). Diet modifications and meal-related behaviors were the most common strategy for bowel 
control (13 focus groups, N=63).  A second analysis described the specific bowel symptoms that 
were mitigated or exacerbated by diet modifications (N=577). Fruits and vegetables were helpful in 
mitigating constipation, obstruction, frequency, and improving predictability. Survivors also 
endorsed water, fiber-rich foods, cereal, and bread as helpful for bowel symptoms. Troublesome 
foods included vegetables, dairy, fruits, protein, fried foods, spices/spicy food, nuts, and sweets. 
These foods reportedly increased diarrhea, gas, and urgency. 

 
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A single group, pre-post intervention study was initiated to evaluate the feasibility and acceptability 
of AIMS-RC in 10 rectal cancer survivors.60 A total of 20 patients were eligible and were invited to 
participate. Of these, 3 declined participation (no time, being overwhelmed); 16 consented (average 
of four per month). Of these, six were lost to follow-up after consent. A process evaluation 
suggested that consent by the study CRA, largely independent of clinic personnel, may have 
contributed to higher early loss to follow-up. Of the remaining 10 participants, eight completed the 
sessions. One participant completed 4 sessions and declined further participation.  Another 
completed 5 sessions, suffering a major life event that precluded further engagement. Mean age 
was 57 ± 2.55 years, and the majority were female (80%). Four had anastomosis, 3 had a 
temporary ostomy and re-anastomosis, and 2 had a permanent ostomy. Average length of the 
telephone sessions was approximately 30 minutes. The majority of participants found the 
intervention helpful and acceptable. Safety data for a control intervention are not available as the 
study was a single group, pre-post intervention design with no control condition. Of note, we did 
not experience any safety issues or concerns from patients in the pilot study. 
 
Inclusion of Women and Minorities and Planned Enrollment Report 
 
This study was designed to include women and minorities. We expect adequate representation of 
women in the trial.  The anticipated accrual in the ethnicity/race and sex categories for randomized 
patients is shown in the table below. 
 
 
 
 
3.0 
DRUG INFORMATION 
 
Drug information is not applicable to this study.  
 
 
4.0 
STAGING CRITERIA 
 
There are no staging criteria applicable for study enrollment. The American Joint Committee on 
Cancer 2010 Staging System, 8th Edition for rectal cancer is listed in Appendix 18.1 as a reference 
only.  
 
5.0 
ELIGIBILITY CRITERIA 
 
Each of the criteria in the following section must be met for a patient to be considered eligible for 
either Step 1 or Step 2 registration in OPEN.  For each criterion requiring test results and dates, 
please record this information on the Onstudy Form and submit via Medidata Rave® (see Section 
DOMESTIC PLANNED ENROLLMENT REPORT 
Racial 
Categories 
Ethnic Categories 
Total 
Not Hispanic or Latino 
Hispanic or Latino 
Female 
Male 
Female 
Male 
American 
Indian/ Alaska 
Native 
0 
0 
0 
0 
0 
Asian 
2 
1 
0 
0 
3 
Native Hawaiian 
or Other Pacific 
Islander 
0 
0 
0 
0 
0 
Black or African 
American 
4 
2 
0 
0 
6 
White 
50 
31 
2 
1 
84 
More Than One 
Race 
0 
1 
0 
0 
1 
Total 
56 
35 
2 
1 
94 

 
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14.3).  Any potential eligibility issues should be addressed to the SWOG SDMC in Seattle at 
206/652-2267 or cancercontrolquestion@crab.org prior to registration.  
 
In calculating days of tests and measurements, the day a test or measurement is done is 
considered Day 0.  Therefore, if a test is done on a Monday, the Monday 4 weeks later would be 
considered Day 28.  This allows for efficient patient scheduling without exceeding the guidelines.   
 
Prior to Step 1 registration, patients must meet the following criteria: 
 
5.1 
Disease Related Criteria 
 
a. 
Patients must have prior history of rectosigmoid colon cancer, rectal cancer, or 
sigmoid colon cancer.  For patients with sigmoid colon cancer, there must be 
documentation of either partial proctectomy and/or anastomosis to the rectum 
 
b. 
Patients must have a post-surgical permanent ostomy or anastomosis. 
 
5.2 
Prior/Concurrent Therapy Criteria 
 
a. 
Patient’s last date of treatment for rectal cancer (any surgery, chemotherapy, 
radiation therapy) must be at least 6 months prior to registration and not more than 
24 months prior to registration. 
 
5.3 
Clinical/Laboratory Criteria 
 
a. 
Anastomosis patients must have low anterior resection syndrome (LARS) score of 
21-42 (minor to major symptoms) within 7 calendar days prior to registration.  
 
b. 
Patient must have completed all baseline questionnaires within 7 days prior to 
registration.  (See Section 18.5 for COVID-19-related exception.) 
 
c. 
The S1820 Patient Contact form must be completed prior to patient registration. 
 
d. 
Patients must be able to read, write and speak English. Study materials and 
telephone calls are only available in English. 
 
e. 
Patients must be ≥ 18 years of age. 
 
f. 
Patients with a prior malignancy (other than as noted in Section 5.1a) or concurrent 
malignancy that is currently not being treated, whose natural history or treatment 
(in the opinion of the treating physician) does not have the potential to interfere 
with the safety or efficacy assessment of the investigational regimen are eligible 
for this trial.  
 
g. 
Patients who are currently undergoing treatment for another cancer will have a 
different symptom profile than what this study is targeting and are not eligible. 
 
h. 
Patients who have been diagnosed with inflammatory bowel disease (IBD), such 
as ulcerative colitis or Crohn’s disease, are not eligible.  
 
Prior to Step 2 registration, patients must meet the following criteria: 
 
5.4 
Clinical/Laboratory Criteria 
 
a. 
Patient must meet all eligibility criteria for Step 1. 
 
b. 
Patient must have successfully completed (“pass”) the run-in period, as per email 
notification from the University of Arizona (see Section 7.1). 

 
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c. 
Patient must be registered to Step 2 no more than 40 days after Step 1 registration.  
If Day 40 falls on a weekend or holiday, the limit may be extended to the next 
working day. 
 
5.5 
Regulatory Criteria 
 
a. 
Patients must be informed of the investigational nature of this study and must sign 
and give written informed consent in accordance with institutional and federal 
guidelines. Remote consent is allowed with adequate documentation, as outlined 
in Section 18.6.  
 
b. 
As a part of the OPEN registration process (see Section 13.3 for OPEN access 
instructions) the treating institution's identity is provided in order to ensure that the 
current (within 365 days) date of institutional review board approval for this study 
has been entered in the system. 
 
 
6.0 
STRATIFICATION FACTORS 
 
Randomization will be dynamically balanced according to sex (female vs. male) and ostomy status 
(permanent ostomy vs. anastomosis).  
 
 
7.0 
STUDY PROCEDURES 
 
For study procedure-related questions, please contact the SWOG Statistics and Data Management 
Center (SDMC) in Seattle at 206/652-2267 or cancercontrolquestion@crab.org. For questions 
related to the study intervention, please contact the Study Chair, Virginia Sun, Ph.D., R.N. at 
626/218-3122, 626/257-4717. If Dr. Sun is not available, contact the University of Arizona at aims-
rc@email.arizona.edu, toll free number: 855-624-AIMS.   
 
See Appendix 18.3 for a general overview of the study. 
 
7.1 
Communication Between Study Sites and University of Arizona: 
 
Study site staff must be aware of and follow their institutional policies related to 
transmission of Protected Health Information (PHI). All study related communication 
between the study sites and the University of Arizona will happen through the following 
secure modes only: 
 
a. 
REDCap-generated secure form – within 24 hours of Step 1 registration, the site 
must complete the S1820 Patient Contact Form to provide clinic and patient 
information to the University of Arizona via the following link: https://is.gd/aims_pcf. 
This allows the information to be sent securely and efficiently to the University of 
Arizona. (See Section 18.5 for COVID-19-related exception.) 
 
b. 
Telephone calls using the study-specific toll-free number (855-624-AIMS) are used 
by the site staff to communicate questions about the coaching calls or telephone 
assessments to the University of Arizona.  
 
c. 
Secure emails (aims-rc@email.arizona.edu) are used by the University of Arizona 
to communicate run-in results to site staff. It will also be used by the University of 
Arizona to communicate patient’s refusal to continue with the coaching calls.  
 
 

 
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7.2 
Study Flow Diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*  
(See Section 18.5 for COVID-19-related exception.) 
 
 
 
STUDY SITE ACTIVITIES 
UNIVERSITY OF ARIZONA (UA) 
ACTIVITIES 
• Present study to patient 
• Consent patient 
• Verify eligibility (including LARS for 
anastomosis patients) 
• Collect completed baseline questionnaires 
• Complete S1820 Patient Contact Form 
• Give patient run-in packet 
• Register patient to Step 1 in OPEN 
• Submit S1820 Patient Contact Form to 
University of Arizona within 24 hours* 
• Submit study forms in Rave 
SWOG SDMC notifies University of Arizona of 
Step 1 registration 
• Conduct run-in assessments with patient 
• Notify site of patient run-in status via email 
• Within 5 days of receiving email from University 
of Arizona, evaluate patient for Step 2 2 
eligibility* 
 
         Not eligible                              Eligible 
SWOG SDMC notifies University of Arizona of 
patient status and randomization assignment, if 
applicable 
• Submit S1820 
Pre-Randomization 
Off Study form 
• Register patient to 
Step 2 
(randomization) in 
OPEN 
• Conduct telephone sessions with randomized 
patients 
• Notify site when patient has completed all 
sessions 
• Administer telephone BFI and 24-hour dietary 
recall at Week 18 
• Administer telephone BFI and 24-hour dietary 
recall at Week 26 
• Administer Week 26 questionnaires 
• Submit study forms in Rave 
• Administer Week 18 questionnaires 
• Submit study forms in Rave 
SITE AND UNIVERSITY OF ARIZONA ACTIVITIES 

 
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7.3 
Run-In Period 
 
Recruitment Strategies: All eligible patients will be screened and recruited by the 
enrollment site staff. All patients will be inform consented by enrollment site staff. A major 
source of direct recruitment at enrollment sites include direct referrals from surgical, 
medical oncology, radiation oncology clinics. For enrollment sites with an existing 
survivorship clinic and/or ostomy clinics, potential patients can be recruited directly from 
survivorship care teams and/or ostomy nurses. Additionally, patients will be recruited 
through colorectal cancer advocacy groups and SWOG Cancer Research Network patient 
advocate efforts. Recruitment strategies will be vetted with the SWOG Cancer Research 
Network Recruitment and Retention Committee in accordance with established guidelines 
and policies.  
 
All patients registered to Step 1 will be asked to complete the study run-in activities. The 
run-in period and related activities are designed to enhance patient participation in the 
study and enhance adherence to procedures in both randomization arms. The run-in period 
will range between 14-21 days after Step 1 registration.  
 
NOTE: Sites will receive a supply of run-in packets after completing recruitment site 
training. If more run-in packets are needed, they can be requested by completing a form 
via the following link: http://j.mp/2EKjuEk.  Each run-in packet includes the following: 
 
1) BFI (versions for both anastomosis and ostomy);  
2) 3-day food and symptom diary;  
3) written instructions and examples for the food and symptom diary;  
4) Food Amounts Booklet (FAB) for 24-hour dietary recall;  
5) run-in-period calendar;  
6) postage paid envelope. 
 
Procedures for the run-in period are as follows:  
 
1. 
The site must consent the patient, verify eligibility (including the LARS for 
anastomosis patients) and verify all baseline questionnaires are complete 
(see Section 9.0 and Section 15.1). Eligible patients will be registered to 
Step 1. 
 
Patients will receive a run-in packet by site staff. The sites will inform the 
patient to review the packet at home and to expect a telephone call from 
the University of Arizona for instructions on using the packet. The site will 
write the patient’s full name on the cover page of the run-in packet, above 
the box for the SWOG patient ID. The University of Arizona staff member 
will provide the SWOG Patient ID to the patient during their first call. 
 
2. 
Site register patients to Step 1. Send S1820 Patient Contact Information 
form per Section 7.1a. 
 
3. 
Within 48 hours of receiving the S1820 Patient Contact Information form 
and receiving confirmation from the SDMC that the patient has been 
registered to Step 1, a trained staff member from the University of Arizona 
will contact the patient via telephone. The University of Arizona staff 
member will provide run-in instructions and support to the patient on the 
use of the 3-day food/symptom diary, schedule the baseline 24-hour 
dietary recall, and answer any additional questions the patient may have 
about the study or the run-in packet materials. The patient will be 
instructed to complete the 3-day food/symptom diary within 5 days, and 
mail or email (patient preference) the diary back to the University of 

 
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Arizona within 5 days of completion. The trained staff member will attempt 
to administer the BFI and the 24 hour dietary recall at this time or schedule 
a more convenient time for the patient.  
 
4. 
Trained staff at the University of Arizona will review the returned diary and 
evaluate successful completion according to protocol standards.  
 
5. 
A trained staff member at the University of Arizona will call the patient to 
administer the BFI and the 24-hour dietary recall.  
 
6. 
Trained staff at the University of Arizona will evaluate successful 
completion of the run-in period requirements (“pass” vs. “not pass”) based 
on the criteria listed in Section 10.2.  
 
7. 
The site will receive a secure email from the University of Arizona 
confirming the patient’s run-in completion status (“pass” or “not pass”). The 
site assesses the patient for eligibility for Step 2 registration within 5 days 
after receipt of that email (Step 2 Eligibility Assessment schema). Patients 
eligible for Step 2 randomization must be registered within 5 days after 
receipt of the run-in status confirmation email. For patients who will not be 
registered to Step 2, the site must submit the S1820 Pre-Randomization 
Off Study form per Section 14.4.  (See Section 18.5 for COVID-19-related 
exception.) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Step 2 Eligibility Assessment 
Did the patient 
pass the run-
in? 
Does the patient 
meet all Step 2 
eligibility 
criteria? 
Patient is not 
eligible for Step 2. 
Patient is eligible 
for Step 2 
randomization. 
Patient is not 
eligible for Step 2. 
No 
Yes 
Yes 
No 

 
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7.4 
Bowel Symptom Management Assessment 
 
To obtain data on additional bowel symptom management and assess site standard of care 
bowel symptom treatment for each participant, sites must complete two questions in the 
S1820 Onstudy Form (completed before Step 1 registration), and at each follow-up 
timepoint (Week 18 and Week 26) using the S1820 Follow-Up Form.   
 
7.5  
Arm 1:  Intervention Arm (AIMS-RC) 
 
AIMS-RC sessions are targeted to begin within 10 days of randomization and are delivered 
over approximately 17 weeks via 10 telephone sessions that last 15-60 minutes each. (See 
Table 7.5). University of Arizona staff mails an AIMS-RC resource manual to patients; this 
is used during the sessions to guide discussions between the coach and patients. Details 
on each of the sessions are provided in Appendix 18.2. 
 
The Intervention Arm (AIMS-RC) is delivered in addition to standard of care for post-
treatment rectal cancer survivors. All patients will continue to receive standard care per 
their physician and care team’s direction at the enrollment sites. Our intent is not to replace 
or change standard care being provided. 
 
The AIMS-RC sessions are centrally-administered via telephone by one trained health 
coach and one back-up coach (as needed only) from the University of Arizona. The health 
coach will only be working with patients randomized to the Intervention Arm. The health 
coach has experience with health coaching among cancer survivors and has been trained 
on rectal cancer-specific knowledge. The health coaches were jointly trained by Drs. Sun, 
Thomson, and Crane; their delivery of the intervention will be monitored by the Study Chair 
and Co-Chairs throughout the study.  
 
a. 
Motivational Text/Email Messaging 
 
Patients receive electronic communication messaging between scheduled 
telephone calls after Session 6. Patients have the option of receiving the messages 
via smartphone text messaging (SMS) and/or email messaging.  The messages 
are specific to the AIMS-RC intervention to support participant-specific bowel 
symptom management goals. Health coaches use the messages to provide 
support, promote diet behavior change and bowel symptom management, and to 
sustain participant engagement. Patients will receive three messages per week 
after Session 6, when calls move to every other week. The messaging ends after 
Session 10 (end of intervention).  
 
b. 
Newsletters 
 
 
 
Patients will receive quarterly newsletters during the 17 weeks of telephone 
sessions. The newsletter is designed to sustain patient engagement throughout 
the 17 week intervention. The content will vary each month and will contain 
information to support diet modification skills. The health coaches will send 
newsletters to the participants.   
 
 

 
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Table 7.5 Arm 1: AIMS-RC Intervention Coaching Call Content 
SESSION 
SESSION CONTENT 
PARTICIPANT ACTIVITIES 
1 
(Week 1) 
Introductions, program 
overview Review food & 
symptom diary Wellness 
Plan/goals overview 
Food and symptom diary 
Reflect on wellness plan 
2 
(Week 2) 
Review food and symptom 
diary Introduction to food trials 
Introduction to SMART goals 
Food and symptom diary 
Review pages in 
handbook 
3 
(Week 3) 
Review food and symptom 
diary Implementation of food 
trial 
Set SMART goal 
Review handbook as 
needed  
Work on SMART goal 
4 
(Week 4) 
Review food and symptom 
diary Continuation of food trial 
Set SMART goal 
Review handbook as 
needed  
Work on SMART goal 
5 
(Week 5) 
Review food and symptom 
diary Continuation of food trial 
Other symptom management 
strategies Set SMART goal 
Review handbook as 
needed  
Work on SMART goal 
6 
(Week 6) 
Review food and symptom 
diary Continuation of food trial 
Other symptom management 
strategies Set SMART goal 
Review handbook as 
needed  
Work on SMART goal 
7 
(Week 8) 
Review food trial, problem 
solving Review survivorship 
recommendations Set SMART 
goal 
Work on SMART goal 
**Begin receiving text/email 
messages 
8 
(Week 10) 
Review food trial, problem 
solving Review survivorship 
recommendations Set SMART 
goal 
Review handbook as 
needed Work on SMART 
goal 
**Receive 3 text/email 
messages this week 
9 
(Week 14) 
Review food trial, problem 
solving Review survivorship 
recommendations Set SMART 
goal 
Work on SMART goal 
**Receive 3 text/email 
messages this week 
10 
(Week 18) 
Review Wellness Plan 
Final ref1ections on 
knowledge/skills 
No further activities 
**Receive 3 text/email 
messages this week 
 
 
 

 
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7.6 
Arm 2:  Attention Control Arm 
 
The Attention Control sessions begin within 10 days of randomization and are delivered 
over approximately 17 weeks via 10 telephone sessions that last about 15-60 minutes each 
(see Table 7.6). University of Arizona staff mails a Health Education resource manual to 
patients; this is used during the sessions to guide discussions between the coach and 
patients. Our choice of the attention control arm (Healthy Living Education) is based on our 
previous experience with the design of control conditions for behavioral interventions (i.e. 
GOG/NRG 225). The 10 topics are selected based on national survivorship guidelines on 
healthy living post-treatment for cancer survivors.  
 
The Attention Control Arm (Healthy Living Education) is delivered in addition to standard 
of care for post-treatment rectal cancer survivors. All patients will continue to receive 
standard care per their physician and care team’s direction at the enrollment sites. Our 
intent is not to replace or change standard care being provided. 
 
The Attention Control sessions are centrally administered via telephone by one trained 
health coach and one back-up coach (as needed) from the University of Arizona. The 
health coach will only be working with patients randomized to the Attention Control Arm. 
The Attention Control Arm coaches are different from the Intervention Arm coaches.  The 
health coach has experience with health coaching among cancer survivors and has been 
trained on rectal cancer-specific knowledge. They were jointly trained by Drs. Sun, 
Thomson, and Crane; their delivery of the Health Education program will be monitored by 
the Study Chair and Co-Chairs throughout the study.  
 
a. 
Text/Email Messaging 
 
Patients receive electronic communication messaging between scheduled 
telephone calls after Session 6. Patients have the option of receiving the messages 
via short smartphone text messaging (SMS) and/or email messaging. The 
messages are used for retention purposes only. They are standardized messages 
containing information on the 10 topics listed in Table 7.6. Patients receive three 
messages per week beginning with Session 6 when calls move to every other 
week. The messaging will end after Session 10.  
 
b. 
Newsletters 
 
 
Patients will receive quarterly newsletters during the 17 weeks of telephone 
sessions. The newsletters are designed to sustain patient engagement throughout 
the 17 week intervention. The content will vary each month and will contain 
information on the ten healthy living education topics designed for the attention 
control condition.  
 
 

 
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Table 7.6 Arm 2: Attention Control Call Content 
Session 
Session Content 
Weekly Activities 
Session 1  
(within 10 days of 
randomization) 
• Introductions 
• Program overview 
• ACS Diet and Activity 
•  
Sessions 2-6 (weekly 
calls) 
 
• Sleep 
• Skin Care 
• Sun safety 
• Active wear 
• Bone health 
• None 
Sessions 7-8 
(every other week 
calls) 
 
• Food safety 
• Survivorship and 
Surveillance 
•  
• Receive SMS/emails 
(3 per week) 
 
Sessions 9-10 
(monthly calls) 
• Evaluating online 
resources 
• Clinical Trials 
• Program Wrap-Up 
 
• Receive SMS/emails 
(3 per week) 
 
 
7.7 
Assessment Telephone Calls 
 
a. 
The BFI is administered by telephone by University of Arizona research staff, 
independent of the study coordinator and study health coaches, during the run-in 
period, at week 18 and week 26. The questionnaire takes approximately 10 
minutes to complete. Data will be collected in REDCap and transferred to RAVE® 
by University of Arizona staff trained in research data collection.  
 
b. 
24-hour dietary recalls will be collected during the run-in period, at week 18 and 
week 26 by trained dietary assessors at the University of Arizona, independent of 
the study coordinator and study health coaches. The data are collected via 
telephone and reflect patient recall of all food and beverages consumed in the prior 
24-hour period. Data are collected using the University of Minnesota Nutrient Data 
System for Research (NDS-R); summary nutrient analyses will be derived from the 
NDS-R nutrient database.  
 
7.8 
Criteria for Removal from Protocol Intervention 
 
a. 
Completion of all coaching calls. 
 
b. 
Re-initiation of cancer treatments due to disease recurrence/progression.  
 
c. 
The patient may withdraw from the study at any time for any reason. 
 
d. 
Patient death. 
 
7.9 
Discontinuation of Protocol Intervention 
 
a. 
All reasons for discontinuation of study intervention (coaching calls) must be 
documented in the S1820 Off Treatment Notice. 
 
b. 
The University of Arizona staff will notify the site via secure email when a patient 
completes or discontinues the intervention (coaching calls).  
 
 

 
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7.10 
Follow-Up Period 
 
Patients who are registered but ultimately not randomized will require no additional follow 
up.  
 
All randomized patients will be followed for 26 weeks after randomization. 
 
 
8.0 
TOXICITIES TO BE MONITORED AND DOSE MODIFICATIONS 
 
This is not a treatment study. No dose modification instructions or adverse event information will 
be collected. Symptoms will be assessed by the investigator at each study visit. 

 
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9.0 
STUDY CALENDAR 
 
REQUIRED STUDIES 
Run-In  
Reg Step 1 
Randomization  
Reg Step 2 
Post-Randomization 
Weeks 1 – 16 7 
Week 18  
(+/- 2 weeks) 
Week 26 
(+/- 2 weeks) 
PATIENT QUESTIONNAIRES 9 
S1820 Run-In Packet 1 
X 
  
  
  
  
LARS 8 
X 
  
  
X 
X 
Quality of Life 2 
X 
  
  
X 
X 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
X 
  
  
X 
X 
S1820 Reasons for Managing Bowel Health 
X 
  
  
X 
X 
Positive and Negative Affect Scale (I-PANAS-SF) 
X 
  
  
X 
X 
S1820 Baseline Questionnaire 2 
X 
  
  
  
  
Acceptability of Intervention Measure 
  
  
  
 X 
X 
SITE COMPLETED FORMS 9 
Registration Worksheet - Step 1 (not submitted) 
X 
  
  
  
  
S1820 Patient Contact Form 4 
X 
  
  
  
  
Vital Status 
X 
  
  
X 
X 
S1820 Onstudy 
X 
  
  
  
  
S1820 Investigator Symptom Assessment 
X 
 
 
X 
X 
S1820 Cover Sheet for Patient-Completed Questionnaires 
X 
  
  
X 
X 
S1820 Pre-Randomization Off Study 
X 5 
 
  
  
  
S1820 Registration Worksheet - Step 2 (not submitted) 
  
X 
  
  
  
S1820 Follow Up 
  
  
  
X 
X 
S1820 Off Treatment Notice 6 
  
  
  
  
  
SITE COMPLETED ASSESSMENT 
Vital Signs 10 
 X 
  
  
X  
 X 
ARIZONA DIRECTED DATA COLLECTION AND PATIENT CONTACTS 
Run-in Telephone Calls 
X 3 
  
  
  
  
Assessment Telephone Calls 
  
  
X 
X 3 
X 3 
Arm 1: Intervention Telephone Calls 
  
  
X 
  
  
Arm 2: Attention Control Telephone Calls 
  
  
X 
  
  

 
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Footnotes: 
 
 
 
 
 
 
1 Site must give the patient the run-in packet, but it will not be collected by the site. It is to be completed at home by the patient, for use during run-in 
telephone calls. 
2  Use anastomosis or ostomy version, as appropriate 
3  Includes dietary recalls and BFI assessment (primary endpoint) 
4  Submitted to Arizona via REDCap 
5  Submit only if patient will not be registered to Step 2 
6  Submit after patient completes intervention (coaching calls) or otherwise meets criteria in Section 7.8 
7 
All coaching calls are planned for completion by Week 18. Due to the patient’s schedule, the calls may extend beyond 18 weeks. 
8 
For anastomosis patients only 
9 
All data collection time points (baseline, Week 18, Week 26) should be aligned with standard clinic visits for rectal cancer surveillance (every 3-6 months), 
per NCCN Clinical Guidelines. If a patient has a clinic visit that falls outside the window for data collection, sites are allowed to collect patient 
questionnaires by the telephone. 
10 Vital signs: temperature, weight, heart rate, respiratory rate, and blood pressure. Sites should assess for these signs but are not required to collect the 
data and submit via Medidata RAVE®. 
 
 
 
 
 
 

 
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10.0 
CRITERIA FOR EVALUATION AND ENDPOINT ANALYSIS 
 
10.1 
Primary Endpoint 
 
The primary endpoint for this study is bowel function at 18 weeks after randomization, as 
measured by Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) 
total score.  
 
The BFI is a validated instrument that assesses bowel function in post-surgery rectal 
cancer patients. Total scores range from 18 to 90; higher scores indicate better bowel 
function. The responses are measured on a 5-point Likert scale, apart from the frequency 
of bowel movements item.61, 62 There are separate versions for patients with ostomy (17 
items) and anastomosis (20 items). The BFI total score was validated in an observational 
cohort of post-surgery rectal cancer patients, but only in those with anastomosis not 
ostomies.61 The results of a recent confirmatory factor analysis of data from that cohort 
showed that an eight-item BFI total score that excludes frequency items is valid and reliable 
and can apply to people with ostomy or anastomosis.92  Bowel function is assessed during 
the run-in (this is the baseline measure), and at Week 18 and Week 26 via telephone 
interview by the University of Arizona. 
 
 
 
 
10.2 
Exploratory Endpoints 
 
a. 
Bowel function: Dietary, Urgency, Frequency 
 
The BFI has three subscales: a four-item Dietary subscale (score range of 4–20), 
a four-item Urgency subscale (4–20), and a 6-item Frequency subscale (6–30); 
higher scores indicate better bowel function. The responses are measured on a 5-
point Likert scale, apart from the frequency of bowel movements item.61, 62 
 
b. 
Low Anterior Resection Syndrome (LARS) 
 
Lower anterior resection syndrome is measured using the LARS Score, a validated 
5-item instrument that evaluates severe long-term bowel dysfunction in post-
surgery rectal cancer patients. 33 Scores range from 0 to 42 points. Scores are 
categorized into three groups: no LARS (0-20), minor LARS (21-29), and major 
LARS (30-42).63-65 This instrument will only be used with anastomosis patients. 
LARS is assessed prior to Step 1 registration (baseline), Week 18 and Week 26. 
 
c. 
Quality of Life 
 
The City of Hope-Quality of Life-Colorectal Cancer (COH-QOL-CRC) is a validated 
instrument that assesses overall quality of life in post-surgery colorectal cancer 
patients. It evaluates overall QOL and four QOL dimensions: physical, 
psychological, social, and spiritual well-being. The overall score is calculated using 
all subscales, with a range of 0 to 10; higher scores indicate higher quality of life. 
Subscales scores are also scaled from 0 to 10, with higher scores indicating higher 
quality of life in that domain.66 There are separate versions for patients with ostomy 
(43 items) and anastomosis (35 items). Quality of life is assessed prior to Step 1 
registration (baseline), Week 18 and Week 26. 
 
d. 
Dietary Quality 
 
Dietary quality is based on the Healthy Eating Index 2015 (HEI-2015), which 
reflects the American Cancer Society dietary guidance for prevention and 

 
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survivorship (greater fruit, vegetable and grain intake, lower animal fat intake, 
greater fiber intake, and lower empty calorie intake that contributes to undesirable 
weight status). Dietary quality scores are calculated from the dietary recall data 
according to the HEI-2015 67-72 and adapted for restriction in alcohol intake. Scores 
range from 0 to 100, with higher scores indicating higher diet quality. Dietary quality 
is measured during the run-in period (baseline), Week 18 and Week 26. 
 
e. 
Motivation 
 
Motivation is measured using a 10-item scale assessing motivation to change 
dietary behaviors in rectal cancer survivors from the S1820 Reasons for Managing 
Bowel Health form. It was developed internally, based on the Reasons for Quitting 
(Intrinsic and Extrinsic Motivation) scale.73 Items are scored on a 5-point Likert 
scale, from 0 (“Not true at all”) to 4 (“Extremely true”). The score is calculated by 
summing all responses; higher scores indicate higher motivation. Motivation is 
assessed prior to Step 1 registration (baseline), and at Week 18 and Week 26. 
 
f. 
Self-Efficacy 
 
Self-efficacy is measured using the Patient-Reported Outcomes Measurement 
Information System (PROMIS) Self-Efficacy for Managing Symptoms – Short Form 
4a, a validated instrument that measures confidence in one’s ability to successfully 
perform specific tasks or behaviors related to self-efficacy for managing symptoms. 
The four items are scored on a 5-point Likert scale, from 1 (“I am not at all 
confident”) to 5 (“I am very confident”). The overall score is calculated by summing 
all responses and converting to a PROMIS T-score; higher scores indicate greater 
self-efficacy.74 Self-efficacy is assessed prior to Step 1 registration (baseline), 
Week 18 and Week 26. 
 
g. 
Positive and Negative Affect 
 
Affect is measured using the 10-item International Positive and Negative Affect 
Schedule Short Form (I-PANAS-SF), a validated instrument comprised of two 
mood scales: Positive Affect (PA) and Negative Affect (NA).75, 76 The scores are 
calculated by summing the responses for positive and negative affect items 
separately. Scores range from 5 to 25, with higher scores on these scales indicate 
greater positive affect or negative affect, respectively. Affect is assessed prior to 
Step 1 registration (baseline), Week 18 and Week 26. 
 
h. 
Feasibility, adherence, retention, and acceptability 
 
Feasibility, adherence, retention, and acceptability are descriptive measures that 
will be used to characterize the successfulness of the intervention in this pilot trial 
and guide the study team in preparing for the Phase III trial. These measures are 
evaluated based on data obtained throughout the study period. 
 
Feasibility is measured by the percentage of patients who successfully complete 
(“pass”) the run-in period and are randomized. Successful completion is defined 
as meeting all five of the following measures: 
 
1. 
Patient answers the telephone calls from trained staff at the University of 
Arizona. 
 
2. 
Patient completes 24-hour dietary recall with trained staff from University 
of Arizona. 
 

 
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3. 
Patient completes the food and symptom diary with least 3 entries of any 
kind (food OR symptom) for 3 days (consecutive or not).  
 
4. 
Patient returns their food and symptom diary, by mail or email, to the 
University of Arizona within 14 days of completion.  
 
5. 
Patient completes the BFI with trained staff from University of Arizona. 
 
Adherence measures successful completion of intervention or attention control 
coaching calls. Adherence is defined as completing all five of Sessions #1-5 and 
at least three of Sessions #6-10 within 18 weeks after randomization; patients who 
do not meet this criterion are classified as non-adherent.  
 
Retention is defined by completion of follow-up assessments in Step 2, including 
those administered at follow-up site visits and the dietary recalls. 
 
Acceptability is measured for all participants using the Acceptability of Intervention 
measure (AIM)77. It is scored on a 5-point Likert scale from 1 (“completely 
disagree”) to 5 (“completely agree”). Acceptability is assessed at Week 18 and 
Week 26. 
 
 
11.0 
STATISTICAL CONSIDERATIONS  
 
11.1 
Primary Endpoint and Sample Size 
 
The primary endpoint for this study is bowel function total score at 18 weeks after 
randomization, as measured by the BFI. Thirty-seven patients per arm (74 total) 
will provide 80% power to detect an effect size of 0.5, based on a two-sample t-
test with a 1-sided alpha=0.1. The effect size is justified by data from a study of 
post-surgery rectal cancer patients with anastomosis, which gave a BFI SD 
estimate of 9.3 points61, 62, 78, and a clinically meaningful study arm difference of 
approximately 4.6 points as defined by the Sloan empirical rule effect size (defined 
as a mean difference of approximately 8% of BFI range).79 We assume that the 
0.5 SD effect size is similarly meaningful for the validated eight-item BFI total 
score. 92  We will accrue additional patients to account for 7% ineligibility and 15% 
attrition at 6 months, for a total accrual goal of 94 randomized patients.  
 
11.2 
Primary Endpoint Analyses 
 
The analysis of the primary endpoint will be conducted in all eligible patients 
randomized to the study with 18-week BFI data regardless of adherence to the 
coaching calls, according to a modified intention-to-treat principle. Study arm 
differences in BFI at 18 weeks will be assessed by a linear regression model as a 
function of randomization assignment, BFI baseline value, and stratification 
factors. Due to the low safety risks of this study, we will not perform an interim 
futility analysis. 
 
11.3 
Other Analyses 
 
Given the modest size of this trial, the exploratory endpoint analyses are 
considered hypothesis-generating. Study arm differences in BFI at 26 weeks will 
be assessed by a linear regression model as a function of randomization 
assignment, BFI baseline value, and stratification factors. Other continuous 
exploratory outcomes at both 18 and 26 weeks (BFI subscales, LARS, quality of 
life, dietary quality, motivation, self-efficacy, and positive/negative affect) will be 
assessed by a repeated measures linear regression model as a function of 

 
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randomization assignment, baseline value of the outcome, stratification factors, 
and visit. Robust standard errors will be estimated via generalized estimating 
equations to adjust for correlation between repeated outcome measures. The 
dependent variables will be transformed to approximate normality as appropriate. 
 
Accrual rates and feasibility will be summarized. Study arm differences in 
adherence and retention will be assessed by chi square tests. Study program 
acceptability will be compared across arms via t-test. 
 
Although the sample size provides limited statistical power for subgroup analyses, 
we will explore the impact of sex by reanalyzing all outcomes according to sex as 
feasible. The potential for differential intervention effects according to sex on the 
primary endpoint will also be considered. 
 
To assess the sensitivity of intervention effects to the potential confounding factor 
of site-based symptom management, additional exploratory BFI models will adjust 
for such treatments used by participants at baseline and during the intervention. 
 
11.4 
Accrual  
 
Based on a survey of sites represented at the SWOG Survivorship Committee, we 
estimate availability of at least 600 potentially eligible patients each year. If 75% of 
eligible patients registered to Step 1 will be randomized to Step 2, we anticipate 
registering 126 patients to Step 1. Thus, we have set a target of registering 5-6 
patients per month to Step 1 to allow for complete enrollment to Step 2 
(randomization) in approximately 2 years.  
 
11.5 
Data and Safety Monitoring  
 
A Data and Safety Monitoring Committee will oversee the conduct of the study.  
The Committee consists of four members from outside of SWOG, 3 SWOG 
members, 3 non-voting representatives from the National Cancer Institute (NCI), 
and the Group Statistician (non-voting).  The members of this Committee will 
receive confidential reports every 6 months from the SWOG Statistics and Data 
Management Center, including CTCAE-graded symptom data, and will meet at the 
Group's bi-annual meetings as necessary.  The Committee will be responsible for 
decisions regarding possible termination and/or early reporting of the study, based 
on accrual and feasibility. 
 
 
12.0 
DISCIPLINE REVIEW 
 
There is no discipline review for this study. 
 
 
13.0 
REGISTRATION GUIDELINES 
 
13.1 
Registration Timing 
 
For Step 1 registration: Patients must be registered within 7 days after consent and 
completion of baseline questionnaires. This will allow for timely completion of the run-in 
period at a maximum of 40 days. (See Section 18.5 for COVID-19-related exception.) 
 
For Step 2 registration (randomization): Patients must be registered within 5 days after 
notification of run-in completion from the University of Arizona. (See Section 18.5 for 
COVID-19-related exception.) 
 

 
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13.2 
CTEP Investigator Registration Procedures 
Food and Drug Administration (FDA) regulations and National Cancer Institute (NCI) policy 
require all individuals contributing to NCI-sponsored trials to register and to renew their 
registration annually. To register, all individuals must obtain a Cancer Therapy Evaluation 
Program 
(CTEP) 
Identity 
and 
Access 
Management 
(IAM) 
account 
at 
https://ctepcore.nci.nih.gov/iam. In addition, persons with a registration type of Investigator 
(IVR), Non-Physician Investigator (NPIVR), or Associate Plus (AP) (i.e., clinical site staff 
requiring write access to OPEN, Rave, or acting as a primary site contact) must complete 
their annual registration using CTEP’s web-based Registration and Credential Repository 
(RCR) at https://ctepcore.nci.nih.gov/rcr.    
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 (e.g., Roster Update Management System (RUMS), OPEN, 
Rave,); 
• 
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 

 
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https://ctep.cancer.gov/investigatorResources/default.htm. For questions, please contact 
the RCR Help Desk by email at RCRHelpDesk@nih.gov. 
 
a. 
CTSU Registration Procedures 
 
This study is supported by the NCI Cancer Trials Support Unit (CTSU). 
 
 

 
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1. 
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 
CTSURegPref@ctsu.coccg.org 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 emailing 
the email address above or calling 1-888-651-CTSU (2878). 
 
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 PO on the 
protocol.  
• 
Log on to the CTSU members’ website (https://www.ctsu.org) 
using your CTEP-IAM username and password; 
• 
Click on Protocols in the upper left of your 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 
[Corresponding 
Organization], 
and 
protocol number [NCI Protocol #]; 
• 
Click on Documents, select Site Registration, and download 
and complete the forms provided. (Note: For sites under the 
CIRB initiative, IRB data will load automatically to the CTSU 
as described above.)  
 
3. 
Requirements for S1820 Site Registration: 
 
• 
IRB approval (For sites not participating via the NCI CIRB; local IRB 
documentation, an IRB-signed CTSU IRB Certification Form, Protocol 
of 
Human 
Subjects 
Assurance 
Identification/IRB 
Certification/Declaration of Exemption Form, or combination is 
accepted). 
• 
Study Site Staff Training Requirement: Sites interested in 
participating in S1820 will need to have at least one designated staff 
member complete a training session. Training must be completed 

 
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prior to enrollment of any patients. Training requirements and content 
for can be obtained in the following methods: 
• 
A 2-hour training session will be held at select semi-annual 
meetings (April and October). 
• 
Web-based training will be available and will require online access 
and speakers.  To enroll in the training, sites must register for the 
training at https://www.swog.org/required-s1820-training .  
• 
. A list of study staff training including name, site, contact 
information and date of training completion will be maintained by 
the Study Chair.  The designated trained staff at each SWOG site 
will also be invited to participate in monthly study telephone 
conference calls, which may include training updates.   
• 
If the designated trained staff leaves the SWOG institution, sites 
will need to provide access and completion of training for all new 
personnel participating in this protocol prior to any new enrollment 
of patients. 
 
4. 
Submitting Regulatory Documents:  
 
Submit required forms and documents to the CTSU Regulatory Office via 
the Regulatory Submission Portal on the CTSU website.  
 
To access the Regulatory Submission Portal log on to the CTSU 
members’ website  Regulatory  Regulatory Submission. 
 
Institutions with patients waiting that are unable to use the Regulatory 
Submission Portal should alert the CTSU Regulatory Office immediately 
at 1-866-651-2878 in order to receive further instruction and support. 
 
13.3 
OPEN Registration Requirements 
 
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 Lead Protocol Organization (LPOs) registration/randomization systems or 
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:  Be on a LPO roster, 
ETCTN Corresponding roster, or PO roster with the role of Registrar. 
Registrars must hold a minimum of an AP registration type; 
• 
If a Delegation of Tasks Log (DTL) is required for the study, the registrar(s) 
must hold the OPEN Registrar task on the DTL for the site; and 
• 
Have an approved site registration for a 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. Please print this confirmation for your records.  
 
Access OPEN at https://open.ctsu.org or from the OPEN link on the CTSU members’ 
website. Further instructional information is in the OPEN section of the CTSU website at 
https://www.ctsu.org or https://open.ctsu.org. For any additional questions, contact the 
CTSU Help Desk at 1-888-823-5923 or ctsucontact@westat.com. 
 
13.4 
Registration Procedures  
 
a. 
All site staff will use OPEN to enroll patients to this study.  OPEN is integrated with 
the CTSU Enterprise System for regulatory and roster data and, upon enrollment, 
initializes the patient in the Rave® database.  OPEN can be accessed at 
https://open.ctsu.org, from the OPEN tab on the CTSU members’ side of the 
website at https://www.ctsu.org, or from the OPEN Patient Registration link on the 
SWOG CRA Workbench. 
 
b. 
Prior to accessing OPEN site staff should verify the following: 
 
• 
All eligibility criteria have been met within the protocol stated timeframes and 
the affirmation of eligibility on the Registration Worksheet has been signed by 
the registering investigator or another investigator designate. Site staff should 
refer to Section 5.0 to verify eligibility. 
 
• 
All patients have signed an appropriate consent form and HIPAA 
authorization form (if applicable). 
 
c. 
The OPEN system will provide the site with a printable confirmation of registration 
and intervention information.   Please print this confirmation for your records. 
 
d. 
Further instructional information is provided on the OPEN tab on the CTSU 
members’ side of the website at https://www.ctsu.org or at  https://open.ctsu.org. 
For any additional questions contact the CTSU Help Desk at 888/823-5923 or 
ctsucontact@westat.com. 
 
13.5 
Exceptions to SWOG registration policies will not be permitted. 
 
a. 
Patients must meet all eligibility requirements. 
 
b. 
Institutions must be identified as approved for registration. 
 
c. 
Registrations may not be cancelled. 
 
 
14.0 
DATA SUBMISSION SCHEDULE 
 
14.1 
Data Submission Requirement 
 
Data must be submitted according to the protocol requirements for ALL patients registered, 
whether assigned intervention has been initiated, including patients deemed to be 

 
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ineligible.  Patients for whom documentation is inadequate to determine eligibility will 
generally be deemed ineligible. 
 
14.2 
Master Forms 
 
Master forms can be found on the protocol abstract page on the SWOG website 
(www.swog.org). The sample consent form, and the Registration Worksheet, and the 
S1820 Patient Contact Form must be submitted on-line via the Web; see below for details. 
 
14.3 
Data Submission Procedures 
 
• 
Data collection for this study will be done exclusively through the Medidata Rave® 
clinical data management system. Access to the trial in Rave® is granted through 
the Medidata application to all persons with the appropriate roles assigned in 
Regulatory Support System (RSS). To access Rave® via Medidata, you must have 
an active CTEP-IAM account (check at https://ctepcore.nci.nih.gov/iam) and the 
appropriate Rave® role (Rave® CRA, Read-Only, CRA Lab Admin, SLA, or Site 
Investigator) on either the LPO or participating organization roster at the enrolling 
site. To hold the Rave® CRA role or CRA Lab Admin role, the user must hold a 
minimum of an AP registration type.  To hold the Rave® Site Investigator role, the 
individual must be registered as an NPIVR or IVR.  Associates can hold read-only 
roles in Rave®.  If the study has a DTL, individuals requiring write access to Rave® 
must also be assigned the appropriate Rave® tasks on the DTL. 
 
Upon initial site registration approval for the study in RSS, all persons with Rave® 
roles assigned on the appropriate roster will be sent a study invitation e-mail from 
Medidata. To accept the invitation, site users must log into the Select Login 
(https://login.Medidata.com/selectlogin) using their CTEP-IAM user name and 
password and click on the “accept” link in the upper right-corner of the Medidata 
page. Please note, site users will not be 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 learning (eLearning), and can be accessed by clicking on the 
link in the upper right pane of the Medidata screen. 
 
Users that have not previously activated their Medidata/Rave® account at the time 
of initial registration approval for the study in RSS will also receive a separate 
invitation from Medidata to activate their account. Account activation instructions 
are located on the CTSU website, Rave® tab under the Rave® resource materials 
(Medidata Account Activation and Study Invitation Acceptance). Additional 
information on Medidata/Rave® is available on the CTSU members’ website under 
the Rave® tab at www.ctsu.org/RAVE® / or by contacting the CTSU help Desk at 
888/823-5923 or by e-mail at ctsucontact@westat.com. 
 
• 
You may also access Rave® via the SWOG CRA Workbench via the SWOG 
website (www.swog.org).  
 
For 
difficulties 
with 
the 
CRA 
Workbench, 
please 
email 
technicalquestion@crab.org. 
 
• 
Institutions participating through the Cancer Trials Support Unit (CTSU), please 
refer to the CTSU Participation Table. 
 
14.4 
Data Submission Overview and Timepoints  
 
a. 
WITHIN 24 HOURS AFTER STEP 1 REGISTRATION:  
 
Submit the following: 

 
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S1820 Patient Contact Form (submit to University of Arizona via REDCap; see 
Section 7.1) 
 
b. 
WITHIN 15 DAYS AFTER STEP 1 REGISTRATION:  
 
Submit the following: 
 
Vital Status Form 
 
S1820 Onstudy Form 
 
S1820 Investigator Symptom Assessment 
 
 
Operative report used to document surgery* 
 
Pathology report documenting initial diagnosis* 
  
Discharge summary documenting post-operative complications* 
 
S1820 Cover Sheet for Patient-Completed Questionnaires 
 
LARS (anastomosis patients only) 
 
Quality of Life (anastomosis or ostomy version) 
 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
 
S1820 Reasons for Managing Bowel Health 
 
Positive and Negative Affect Scale (I-PANAS-SF) 
 
S1820 Baseline Questionnaire (anastomosis or ostomy version) 
 
*NOTE: Upload reports via the Source Documentation: Baseline Form in Rave® 
 
c. 
WITHIN 15 DAYS OF NOTIFICATION OF PATIENT RUN-IN STATUS:  
 
Submit the following: 
 
S1820 Pre-Randomization Off Study (if patient will not be registered to Step 2) 
 
d. 
WITHIN 15 DAYS OF WEEK 18 ASSESSMENT (STEP 2): 
 
Submit the following: 
 
Vital Status 
 
S1820 Follow-Up Form 
 
S1820 Investigator Symptom Assessment 
 
S1820 Cover Sheet for Patient-Completed Questionnaires  
 
LARS (anastomosis patients only) 
 

 
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Quality of Life (anastomosis or ostomy version) 
 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
 
S1820 Reasons for Managing Bowel Health 
 
Positive and Negative Affect Scale (I-PANAS-SF) 
 
Acceptability of Intervention Measure 
 
A +/- 14-day window around the target date is permitted for administration of 
patient questionnaires (see Section 15.1) 
 
NOTE: The BFI (anastomosis or ostomy version) and a telephone 24-hour dietary 
recall will be administered by trained University of Arizona staff at Week 18.  
 
e. 
WITHIN 15 DAYS OF WEEK 26 ASSESSMENT (STEP 2): 
 
Submit the following: 
 
Vital Status 
 
S1820 Follow-Up Form 
 
S1820 Investigator Symptom Assessment 
 
S1820 Cover Sheet for Patient-Completed Questionnaires  
 
LARS (anastomosis patients only) 
 
Quality of Life (anastomosis or ostomy version) 
 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
 
S1820 Reasons for Managing Bowel Health 
 
Positive and Negative Affect Scale (I-PANAS-SF) 
 
Acceptability of Intervention Measure 
 
A +/- 14-day window around the target date is permitted for administration of 
patient questionnaires (see Section 15.1) 
 
NOTE: The BFI (Version A or Version O) and a telephone 24-hour dietary recall 
will be administered by trained University of Arizona staff at Week 26.  
 
f. 
WITHIN 15 DAYS OF DISCONTINUATION OF PROTOCOL INTERVENTION 
(COUNSELING TELEPHONE CALLS): 
 
Submit the following: 
 
Vital Status and S1820 Off Treatment Notice 
 
g. 
WITHIN 30 DAYS OF KNOWLEDGE OF DEATH: 
 
Submit the following: 
 

 
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Vital Status, Notice of Death, S1820 Off Treatment Notice (if not already 
submitted), final S1820 Follow-Up form, and final S1820 Cover Sheet for Patient-
Completed Questionnaires 
 
 
 

 
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15.0 
SPECIAL INSTRUCTIONS 
 
15.1 
Administration of Questionnaires to Patients   
 
The primary outcome of this study is a PRO and all patient evaluations are based on PROs. 
 
a. 
Administration Timepoints 
 
1. 
The following data will be self-reported by the patient within 7 days prior 
to Step 1 registration. The data will be collected by enrollment site staff:  
 
• 
LARS (anastomosis patients only) – administered orally by site staff 
• 
Quality of Life (anastomosis or ostomy version) 
• 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
• 
S1820 Reasons for Managing Bowel Health 
• 
Positive and Negative Affect Scale (I-PANAS-SF) 
• 
S1820 Baseline Questionnaire (anastomosis or ostomy version) 
 
Patient baseline questionnaires should be administered the same day the 
patient consents. Patients must be registered (Step 1) within 7 days after 
consent and completion of baseline questionnaires. * 
 
*  See Section 18.5 for COVID-19-related exception. 
 
2. 
The following data will be self-reported by the patient at Week 18 and 
Week 26 (Step 2). The data will be collected by enrollment site staff:  
 
• 
LARS (anastomosis patients only) 
• 
Quality of Life (anastomosis or ostomy version) 
• 
PROMIS Self-Efficacy for Managing Symptoms – Short Form 4a 
• 
S1820 Reasons for Managing Bowel Health 
• 
Positive and Negative Affect Scale (I-PANAS-SF) 
• 
Acceptability of Intervention Measure 
 
The S1820 Cover Sheet for Patient-Completed Questionnaires must be 
submitted for each time point. 
 
Also see Section 14.0 for a list of questionnaires and submission times. 
 
Note that the BFI and dietary recalls are conducted by the University of Arizona 
research staff; these do not require clinic engagement and are not listed here. 
 
b. 
Administration Instructions 
 
1. 
All questionnaires except the LARS will be self-administered; the LARS is 
administered orally by site staff.  Questionnaires are anticipated to require 
45 minutes to complete at baseline and 35 minutes at each follow-up time 
point. When a patient is randomized (registered to Step 2) to S1820, a 
calendar may be made by the local site with dates of upcoming patient-
completed questionnaires noted and provided to the patient at their next 
visit. A copy of the planned questionnaire administration time points should 
be kept in the patient’s research record. 
 
2. 
Target follow-up assessment dates should be based on the date of Step 2 
randomization. A window of ± 14 days is allowed for each assessment to 
provide more flexibility in scheduling. If the patient visit and form 

 
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completion are not within the target window, all attempts should be made 
to complete the next assessment within the target follow-up assessment 
schedule per Section 15.1b and Section 14.0. 
 
3. 
In order to minimize patient burden and streamline patient visits, it is 
preferable for questionnaires to be given to the patient at the clinical visit 
immediately prior to the study time point and to have the patient complete 
it at home and returned at the routine clinical visit coinciding with the study 
time point; however, the study staff should accommodate the patient’s 
preferences for filling out the questionnaires as described below. At time 
of consent, the patient should be provided with a copy of the forms for 
reference. If the participant chooses to complete questionnaire at home, 
research staff should provide a reminder (i.e., via phone call, text or email 
based on preference) to decrease the likelihood that the patient forgets to 
fill out the questionnaires. 
 
4. 
The research site should provide the patient with options for completing 
the questionnaires after the patient has reviewed them. The patient’s 
review may help them decide if they need information, they do not have 
with them at their visit or they may need assistance from a family member 
or caregiver. The patient may also be more comfortable completing the 
questionnaire(s) at home. The options for the patient are as follows: 
 
Complete questionnaires at home. Provide the patient with questionnaires in 
advance and instructions to return them to the site at the clinical visit corresponding 
to the study time point (e.g., give patient questionnaires 2 weeks in advance at a 
routine clinical visit). Review the returned questionnaires for completeness at the 
clinical visit and clarify answers while the patient is at the clinic. If the patient does 
not return the completed questionnaires as scheduled, the patient should complete 
the questionnaires at the clinical visit or schedule a phone contact. 
 
Partially complete the questionnaires in the clinic or practice. If due to illness, 
time or any reason the patient begins completing the questionnaires in the clinic or 
practice but then decides he/she cannot finish one or more questionnaire, make a 
photocopy of the incomplete questionnaire(s), give the patient the copy and keep 
the original in the patient’s research chart. Give the patient a pre-addressed 
stamped envelope to return the questionnaire(s) by mail to the clinic or practice, 
but also schedule a phone call with the patient 1 week later. If questionnaire(s) are 
returned (by mail or in person) within 1 week, use the scheduled phone call to 
clarify any missing or unclear responses (if applicable). If questionnaire(s) are not 
returned, use the scheduled phone call to complete the questionnaire(s) by phone 
interview. 
 
Complete questionnaires by phone interview. If the patient is unable to come 
in for their clinical visits or questionnaires were not completed before or at the 
clinical visit, questionnaires may be completed by phone interview. Phone 
interviews should be scheduled within 1 week of the clinical visit corresponding to 
the study time point. The patient should be given a copy of blank forms (or partially 
completed, if applicable) so that the patient may look at a copy of the 
questionnaires while the staff conducts the interview. The date of the telephone 
interview is to be noted on the S1820 Cover Sheet for Patient-Completed 
Questionnaires. If the phone interview is to complete data on a partially completed, 
form, review all the questions with the patient, even those previously completed, 
in case the patient needs to change a previously answered question. If the phone 
interview is not completed as scheduled, reschedule to remain within the ± 14-day 
window for the study time point. 
 

 
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5. 
As a general reminder, review all completed questionnaires to be sure all 
of the questions have been answered and, when the patient is directed to 
mark only one response, that only one answer is marked. If the patient has 
marked more than one answer per question, ask which answer reflects 
how the patient is feeling. If the patient has skipped a question, tell the 
patient that a question was not answered and ask if the patient would like 
to answer the question. If the patient is unable to answer the question at 
the time of the visit, site staff are encouraged to retain the questionnaire 
and contact the patient by phone to obtain outstanding information. If 
patient does not want to answer a particular question, the study staff will 
enter “Not answered by the patient” in Medidata RAVE®. 
 
6. 
Caregivers may assist patients with their questionnaires by administering 
the questionnaire orally to the patient, helping the patient find information 
and/or recording the patient’s answers. Caregivers cannot answer for the 
patient. For patients who are too sick to complete the questionnaire (even 
with assistance from the caregiver) or who are not able to come to a clinical 
visit (e.g. enrolled in hospice care), the study staff will record on the S1820 
Cover Sheet for Patient-Completed Questionnaires that the patient was 
too sick to complete the questionnaire. 
 
7. 
Patients will not receive incentives (e.g. gift cards, monetary 
compensation) for participation in this study. 
 
8. 
S1820 Cover Sheet for Patient-Completed Questionnaires. For each time 
point, the study staff completes the S1820 Cover Sheet for Patient- 
Completed Questionnaires. The Cover Sheet is submitted with the set of 
patient completed forms at each scheduled assessment. The Cover Sheet 
is very important for tracking how and when the patient forms were 
completed. When a patient-completed form is not administered at a 
scheduled time point, it is important to know why the assessment did not 
occur; the form includes potential reasons for a patient not completing a 
form. All issues of noncompliance are noted on the S1820 Cover Sheet for 
Patient-Completed Questionnaires. 
 
15.2 
Additional Quality Control Procedures 
 
a. 
Anyone involved in the collection of quality of life data in SWOG trials should review 
the training program available on the SWOG website under the Members 
Resources/CRA Workbench tab. After logging on with CTEP-IAM credentials, click 
on the Training link for access to the Patient Reported Outcome Questionnaires 
Training Module. The training program is a narrated set of slides designed to 
standardize the way quality of life data is collected from patients. Questions 
regarding the quality of life assessments can be addressed to the SWOG Statistics 
and Data Management Center (206-652-2267).  
 
b. 
Required Destruction of Source Documents: In accordance with SWOG Policy all 
source documents may be destroyed three-years post completion of the 
study.  Due to a specific contract with a PRO vendor for this study, 
destruction 
of 
the 
I-PANAS-SF 
at 
the 
three-year 
mark 
will 
be 
required.  Destruction of source documents related to this instrument is to include 
all patient completed source documents as well as any unused questionnaires.   All 
such materials are to be destroyed on-site in accordance with institutional 
policy.  Sites will be notified by memo from the SWOG Operations office of the 
destruction date. Destruction of source documents other than the I-PANAS-SF is 
at the discretion of the institution. 
 

 
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16.0 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
The following must be observed to comply with Food and Drug Administration regulations for the 
conduct and monitoring of clinical investigations; they also represent sound research practice: 
 
Informed Consent 
 
The principles of informed consent are described by Federal Regulatory Guidelines (Federal 
Register Vol. 46, No. 17, January 27, 1981, part 50) and the Office for Protection from Research 
Risks Reports:  Protection of Human Subjects (Code of Federal Regulations 45 CFR 46).  They 
must be followed to comply with FDA regulations for the conduct and monitoring of clinical 
investigations. 
 
Institutional Review 
 
This study must be approved by an appropriate institutional review committee as defined by Federal 
Regulatory Guidelines (Ref. Federal Register Vol. 46, No. 17, January 27, 1981, part 56) and the 
Office for Protection from Research Risks Reports:  Protection of Human Subjects (Code of Federal 
Regulations 45 CFR 46). 
 
Monitoring 
 
This study will be monitored by the Clinical Data Update System (CDUS) Version 3.0.  Cumulative 
CDUS data will be submitted quarterly to CTEP by electronic means.  Reports are due January 31, 
April 30, July 31 and October 31. 
 
Adverse Experiences 
 
There is no SAE Reporting for this study. 
 
 
 

 
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17.0 
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18.0 
APPENDIX 
 
18.1 
American Joint Committee on Cancer 2010 Staging System, 8th Edition 
 
18.2 
AIMS-RC Intervention Sessions 
 
18.3 
General Study Description – Overview 
 
18.4 
University of Arizona-Directed Data Collection 
 
18.5 
Allowances during COVID-19 pandemic 
 
18.6 
Procedures for Remote Consent 
 
 
 
 
 
 
 

 
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18.1 
American Joint Committee on Cancer 2010 Staging System, 8th Edition 
 
Primary tumor (pT) 
 
• 
TX: primary tumor cannot be assessed 
• 
T0: no evidence of primary tumor 
• 
Tis: carcinoma in situ, intramucosal carcinoma (involvement of lamina propria with no extension 
through muscularis mucosae) 
• 
T1: tumor invades submucosa (through the muscularis mucosa but not into the muscularis propria) 
• 
T2: tumor invades muscularis propria 
• 
T3: tumor invades through the muscularis propria into the pericolorectal tissues 
• 
T4: 
o 
T4a: tumor invades through the visceral peritoneum (including gross perforation of the bowel 
through tumor and continuous invasion of tumor through areas of inflammation to the surface of 
the visceral peritoneum) 
o 
T4b: tumor directly invades or adheres to other adjacent organs or structures 
 
Regional lymph nodes (pN) 
 
• 
NX: regional lymph nodes cannot be assessed 
• 
N0: no regional lymph node metastasis 
• 
N1: metastasis in 1 - 3 regional lymph nodes 
o 
N1a: metastasis in 1 regional lymph node 
o 
N1b: metastasis in 2 - 3 regional lymph nodes 
o 
N1c: no regional lymph nodes are positive but there are tumor deposits in the subserosa, 
mesentery or nonperitonealized pericolic or perirectal / mesorectal tissues 
• 
N2: metastasis in 4 or more regional lymph nodes 
o 
N2a: metastasis in 4 - 6 regional lymph nodes 
o 
N2b: metastasis in 7 or more regional lymph nodes 
 
Distant metastasis (pM) 
 
• 
M0: no distant metastasis by imaging; no evidence of tumor in other sites or organs (this category is 
NOT assigned by pathologists) 
• 
M1: distant metastasis 
o 
M1a: metastasis confined to 1 organ or site without peritoneal metastasis 
o 
M1b: metastasis to 2 or more sites or organs is identified without peritoneal metastasis 
o 
M1c: metastasis to the peritoneal surface is identified alone or with other site or organ 
metastases 
 
 
 
 
 
 
 
 
 
 
 
 

 
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18.2 
AIMS-RC Intervention Sessions 
 
AIMS-RC is based on the Motivation and Problem-Solving (MAPS) approach. The overarching 
theoretical rationale for MAPS is the social cognitive theory of behavior change.80 The theory 
suggests that even with adequate self-efficacy, an individual may fail without motivation for 
change.81 Similarly, Miller and colleagues82 suggests that an internal motivational shift prompts an 
individual to decide and commit to long-term behavior change. In using the MAPS approach, skills 
training (coping, problem-solving) is systematically added with motivational interviewing (MI) and 
adjusted based on the individual’s level of motivation.  Three constructs are postulated to serve as 
potential mediators to behavior change. Motivation predicts both the decision to change, and the 
likelihood of long-term change. Motivation is dynamic, characterized by frequent fluctuations, and 
can change rapidly based on context.76-79 The MAPS approach places specific emphasis on 
motivation and on appropriate therapeutic responses to common rapid fluctuations in motivation 
that occur throughout the change process. Agency/Self-efficacy reflects the ability to intentionally 
affect one’s behavior.83 Self-efficacy is a form of agency that is context and behavior-dependent; it 
can successfully predict behavior change. MAPS is thought to influence agency through the 
removal of barriers to change, problem-solving and coping skills training, and increased 
motivation.84-86 
 
Positive/Negative Affect are two broad mood factors that are dominant in self-reported mood.87 
Positive affect  (PA) reflects one’s level of pleasurable experience with the environment; in 
contract, negative affect (NA) is a general factor of subjective distress.87 Life stressors, such as 
those experienced by RC survivors, may suppress motivation, decrease self-efficacy, and 
adversely impact long-term behavior change.88-91 Social cognitive theory posits that ambivalence 
and a weak commitment to change can increase NA, particularly during high-risk situations (such 
as those frequently encountered by RC survivors).91 Reductions in NA are thought to increase 
motivation and agency.  
 
The AIMS-RC intervention is also based on the Chronic Care Self-Management Model (CCM).24-27 
It provides one-on-one health coaching to support diet modifications for bowel health and healthy 
survivorship diet. The coaching incorporates cognitive behavioral therapy that is operationalized 
through motivational interviewing techniques to deliver behavior-based, dietary interventions for 
symptom management. The intervention supports behavior change with structured feedback, re-
assessments, and goal setting.   
 
Detailed content for each session is as follows: 
 
a. 
Session 1 
 
This first coaching call is targeted within 10 days after Step 2 randomization. The health 
coach will provide an introduction of the overall program, with support and coaching on use 
of the food and symptom diary. The health coach will provide an overview of the AIMS-RC 
resource manual with support reference materials and intervention content. 
 
b. 
Session 2 
 
This coaching call is targeted to be a week after Session 1. The health coach begins by 
introducing the structure of each telephone session. The resource manual provided in 
Session 1 is introduced and reviewed. Using the food and symptom diary, participants are 
coached to accurately document their food intake and note any symptoms associated with 
the foods. SMART (Specific, Measurable, Attainable, Relevant, Timely) goals for diet 
behavior change in relation to symptom management are identified by the patient, with 
support from the health coaches. 
 
 

 
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c. 
Sessions 3-6 
 
Phone calls once per week: During these calls, the health coach reviews the food/symptom 
diary and SMART goals with the patient. The diary information is used to steer discussion 
on the elimination/substitution process of possible troublesome foods for bowel symptoms. 
The health coach and patient will review the food/symptom diary, as well as problem-solve 
to integrate other symptom management strategies beyond diet modifications (e.g., sitz 
baths, fiber supplements). 
 
d. 
Sessions 7-8 
 
Phone calls once every other week: Here, the health coach focuses on reintroducing, on a 
3-day schedule, patient-identified foods. The elimination/re-introduction diet process helps 
participants identify the main food “culprits” that cause bowel symptoms, but also provides 
the skills needed to re-introduce other foods that are tolerable and beneficial. Participants 
are coached to use problem-solving skills for overcoming diet behavior change challenges. 
Evidence-based diet recommendations for cancer survivorship are also introduced. 
 
e. 
Sessions 9-10 
 
Phone calls once per month. Here, the health coach reviews progress that the participants 
made and the skills they have gained to re-enforce self-efficacy for long-term application 
of the intervention. The health coach also revisits the resource manual and reviews using 
SMART goals for appropriate diet behavior change. 
 
 

 
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18.3  
General Study Description – Overview 
 
See the study flow diagram in Section 7.2.  
 
The patient will complete informed consent and baseline questionnaires during the initial study visit. 
After completion of baseline questionnaires, study site staff will provide patients with a Run-In 
Packet. The site will register eligible patients to Step 1 within 7 days after consent and completion 
of baseline questionnaires. The site will submit the S1820 Patient Contact Form within 24 hours of 
Step 1 registration.  (See Section 18.5 for COVID-19-related exceptions.) 
 
All run-in activities will be performed by the University of Arizona. After a patient has completed the 
run-in period, the University of Arizona will notify the site via email whether the patient successfully 
completed the run-in requirements (“pass” or “not pass”). Within 5 days after receipt of that email, 
the site will evaluate Step 2 eligibility and either register the eligible patient to Step 2 or submit the 
S1820 Pre-Randomization Off Study form for the ineligible patient. There is no additional patient 
consent required for Step 2 registration. (See Section 18.5 for COVID-19-related exceptions.) 
 
The SWOG SDMC will notify the University of Arizona as to which arm the patient has been 
randomized or if they will not be randomized. For randomized patients, the University of Arizona 
will administer the appropriate telephone coaching sessions. The site will administer patient 
questionnaires and submit follow-up data at 18 and 26 weeks after Step 2 registration. Patient 
follow-up is complete after 26 weeks. 
 
 
 

 
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18.4 
University of Arizona-Directed Data Collection 
 
BFI Data Collection 
In addition to their experience in administering instruments via telephone, another advantage of 
having University of Arizona administer the BFI is that the assessor will be blinded to study arm. 
The consistent telephone administration, with blinding of the assessor, will reduce potential 
confounding bias for the BFI, which is the primary endpoint of the trial. 
 
24-Hour Dietary Recall Methodology 
The 24-hour dietary recalls consist of three randomly assigned days per participant at each 
measurement time point including.  Interviewers record all food and beverage consumption over a 
24-hour period using the USDA multi-pass method with the University of Minnesota Nutrition Data 
System-Research Version (NDS-R). The University of Minnesota Nutrition Data System-Research 
Version (NDS-R) is a microcomputer-based system for collection and analysis of dietary data that 
prompts the user to describe food intake at the level of detail such as food source, processing 
method, fat and salt used in preparation, and ingredients that contribute to fat and sodium intake.  
The nutrient database contains over 18,000 foods, 8,000 brand-name products, and many ethnic 
foods.  Values are available for 165 nutrients and nutrient ratios. The database is derived from 
USDA, food manufacturers, foreign food composition tables, and scientific literature.  The recall 
documents type of food/beverages, recipes and preparation, and estimated portion sizes. The 
recall procedures include reviewing data entry for duplicate foods as well as single food items that 
exceed specified calorie, fat or weight amounts.  
 
Other Data Collection 
Data collection for certain exploratory endpoints is performed by University of Arizona staff during 
the run-in period and in conjunction with the coaching calls. The items used to assess successful 
completion of the run-in activities are collected by the University of Arizona and sent to the study 
sites and the SDMC (see Section 7.3). The coaching call completion rate (adherence) and dietary 
recall completion (retention) are collected by the University of Arizona and sent to the SDMC. 
 
 

 
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18.5 
Allowances during COVID-19 pandemic 
 
In order to provide participating sites flexibility during the COVID-19 pandemic, some of the 
timeframes for study procedures are extended.  Use of an extended window does NOT need to be 
reported as a deviation.  However, the rationale for utilization of the extended window must be 
carefully documented in the patient chart as resulting from the COVID-19 pandemic.  
 
Step 1 Registration: 
 
• 
The allowable window between consent/completion of baseline QOL forms and Step 1 
registration is extended to 15 days. 
• 
The allowable window between Step 1 registration and submission of the S1820 Patient 
Contact Form to the University of Arizona is extended to 72 hours. 
 
Step 2 Registration: 
 
• 
The allowable window between receipt of notification of run-in completion from the 
University of Arizona and Step 2 Registration is extended to 10 days. 
 
Note:  The window between Step 1 Registration and Step 2 Registration remains at 40 days. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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18.6 Procedures for Remote Consent 
 
Remote informed consent by telephone is allowed to reduce burden. As is preferred by each 
individual institution, participants may be contacted and recruited in a combination of ways. These 
include in-person clinic visits or remote recruitment via telephone by the study coordinator to 
discuss the study, email and/or mailed letters, using clinically available contact information. Sites 
should follow the NCI’s CIRB Remote Consenting Procedures outlined in Section 18.6 to 
implement a remote consenting process. If a participant is consented remotely, study coordinators 
must wait to receive the participant’s signed consent form (e.g., via mail, fax or email) prior to 
conducting any research activities, including questionnaire administration and step 1 registration. 
 
 
1. 
The participant receives a copy of the informed consent document (e.g., via mail, 
fax, or email) in advance of discussion regarding participation in S1820. If mailed, 
two copies must be mailed so the participant is able to retain a copy for reference 
when their signed document is returned to the site and they are waiting to receive 
the final copy with all necessary signatures back from the site. If postal mail is used, 
a pre-paid, self-addressed envelope must also be provided to the participant to mail 
the signed consent form back to the investigator.  
2. 
The Responsible Investigator/designee discusses S1820 with the potential 
participant either via telephone or video conferencing. The Responsible Investigator 
must have the same consent discussion via telephone/video conferencing that 
would occur with the participant during an in-person meeting.  
3. 
The Responsible Investigator/ designee must also implement a method to ensure 
the identity of the participant, by verification of state identification or other identifying 
documents or use of personal questions or visual methods. 
4. 
A witness must be present during the telephone/videoconferencing consent 
process. There are no restrictions on who can serve as a witness and the witness 
does not need to be impartial. The witness must be able to hear both sides of the 
conversation (e.g., speaker phone, conference line). Requirements for social 
distancing due to Covid-19 or other extenuating circumstances, may dictate that the 
witness may be in a different location than the potential participant and/or the 
Responsible Investigator/designee obtaining consent. Any arrangement is 
acceptable provided that the witness can listen to both parties in the informed 
consent discussion.  
5. 
If the potential participant agrees to participation, they sign the consent form and 
return it to the investigator via mail, fax, or email. 
6. 
Once the research team receives the signed informed consent document(s) from 
the participant, the Responsible Investigator who conducted the consent process 
must also sign and date the document using the current date.  
7. 
Under the signature line, the Responsible Investigator or designee must document 
whether consent was obtained over the telephone or video conferencing, the date 
of the telephone/video conference, and the date the signed consent was received. 
For example, “Discussed with [participant] via [telephone or videoconferencing] on 
[insert date] and received signed consent form on [insert date].” Include a brief 
reason 
for 
performing 
the 
informed 
consent 
discussion 
over 
the 
telephone/videoconferencing. 
8. 
If the site has an informed consent policy that requires the witness to sign the 
consent document, the witness signs the informed consent. If the site does not have 
an informed consent policy that requires the signature of the witness on the consent 
document, then the name of the witness along with the date of the original 

 
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consenting phone call is recorded in the research records to document the 
participation of the witness.  
9. 
The date the Responsible Investigator or designee signs the informed consent 
document, not the date the consent discussion with the participant took place, is the 
official date of informed consent for the participant on the trial.  
10. 
The final informed consent document must be filed in the designated 
investigator/site regulatory file location. A copy of the final informed consent 
document, signed by the participant, the investigator, and the witness (if applicable), 
must be sent back to the participant via email/scan, fax, or postal mail. 
11. 
No research activities related to the study can begin until all steps of the informed 
consent process are complete. 
 
For sites using remote consent that allow the use of electronic signature 
(eSignature), submit the information on the Study Specific Worksheet (SSW) or the 
Signatory Institution Worksheet (SIW) using IRBManager before collecting the 
eSignature.  See Section 13.3a.  
 
Whether consent is obtained in-person or via remote consent, the Responsible 
Investigator or designee will make clear during the consent process that 
participation is voluntary and will not adversely affect the participant’s medical care.