Open Pilot Trial of a Novel Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors
Phase: NA
Conditions: Colorectal Cancer, Anal Cancer, Sexual Dysfunction
Sponsor: Massachusetts General Hospital

Open Pilot Trial of a Novel Mind-Body Sexual Well-Being Intervention for Female GI Cancer 
Survivors (24-009) 
 
NCT06331403 
 
Study Protocol and Statistical Analysis Plan  
Updated July 8, 2024 

PROTOCOL TITLE: Open Pilot Trial of a Mind-Body Sexual Well-Being Program  
 
 
 
 
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PROTOCOL TITLE: 
Open Pilot Trial of a Novel Mind-Body Sexual Well-Being Intervention for Female GI 
Cancer Survivors (NCT06331403) 
Sponsor-Investigator: 
 
 
 
 
Lucy Finkelstein-Fox, PhD 
 
Massachusetts General Hospital 
 
lfinkelsteinfox@mgh.harvard.edu 
 
Principal Investigators (PI): 
 
Lucy Finkelstein-Fox, PhD 
 
Massachusetts General Hospital 
 
lfinkelsteinfox@mgh.harvard.edu 
 
 
VERSION NUMBER:  
2.1 
DATE: 
July 8, 2024 
1.0 
Objectives* .............................................................................................................. 3 
2.0 
Background* ............................................................................................................ 3 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 4 
4.0 
Study-Wide Number of Subjects* ........................................................................... 5 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 5 
6.0 
Multi-Site Research* ............................................................................................... 5 
7.0 
Study Timelines* ..................................................................................................... 5 
8.0 
Study Endpoints* ..................................................................................................... 5 
9.0 
Procedures Involved* ............................................................................................... 8 
10.0 Data and Specimen Banking* ................................................................................ 10 
11.0 Data Management* and Confidentiality ................................................................ 10 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 12 
13.0 Withdrawal of Subjects* ........................................................................................ 12 
14.0 Risks to Subjects* .................................................................................................. 13 
15.0 Potential Benefits to Subjects* .............................................................................. 14 
16.0 Vulnerable Populations* ........................................................................................ 14 
17.0 Community-Based Participatory Research* .......................................................... 14 
18.0 Sharing of Results with Subjects* ......................................................................... 14 
19.0 Setting .................................................................................................................... 15 

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20.0 Resources Available ............................................................................................... 15 
21.0 Prior Approvals ...................................................................................................... 15 
22.0 Recruitment Methods ............................................................................................. 16 
23.0 Local Number of Subjects ..................................................................................... 17 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
25.0 Compensation for Research-Related Injury ........................................................... 18 
26.0 Economic Burden to Subjects ................................................................................ 18 
27.0 Consent Process ..................................................................................................... 18 
28.0 Process to Document Consent in Writing .............................................................. 19 
29.0 Drugs or Devices .................................................................................................... 19 
 

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1.0 
Objectives* 
 
The primary objective of this protocol is to conduct an open pilot to elicit initial 
quantitative and qualitative feedback on the intervention that we are developing. To 
do so, we will deliver our novel intervention to 2 consecutive groups of female colorectal 
and anal cancer survivors (n ~ 10 per group, total N ~ 20). Participants will provide 
feedback regarding intervention acceptability, feasibility, and perceived benefit.  
 
To inform plans for ongoing program refinement, we will also elicit specific feedback 
regarding study assessment tools, recruitment procedures, and group composition. 
 
In future, larger-scale, work, we intend to conduct a larger randomized pilot trial to assess 
intervention acceptability, feasibility, as well as preliminary efficacy on essential indices 
of sexual well-being.   
 
2.0 Background* 
Many female colorectal and anal cancer survivors experience poor sexual quality of life. 
Over 700,000 American women are living with gastrointestinal (GI) malignancies, 
including colorectal or anal cancer.1-3 Mortality for these gastrointestinal cancers is also 
decreasing, suggesting that many women will live as cancer survivors for many years.1 
As a result of GI cancer treatments such as surgery, radiation, and chemotherapy, many 
survivors experience serious long-term side effects such as infertility, diarrhea, 
incontinence, sexual dysfunction, and in many cases, the need for a temporary or 
permanent stoma and colostomy bag.4, 5 Specific sexual effects commonly experienced 
by female survivors include vaginal dryness and dyspareunia (reported by roughly 30% 
of colorectal cancer survivors).4, 6 Further, these physical changes yield indirect effects on 
psychological and relational factors as body image, libido, and ability to enjoy intimacy.6, 
7  
 
Unfortunately, women’s sexual well-being is often neglected in survivorship care.8-10 
Nurse-delivered patient education about vaginal dilators, moisturizers, and lubricants 
demonstrates initial promise for vaginal stenosis among colorectal and anal cancer 
survivors,11, 12 but does not address other aspects of sexual well-being, such as body 
image, reduction of physiological stress symptoms, and communication. Thus, there is a 
need for a novel mind-body intervention to target interacting physiological, emotional, 
cognitive, and relational contributors to women’s sexual well-being in colorectal and anal 
cancer survivorship. 
 
Based on the established scientific literature as well as our own preliminary qualitative 
research, we anticipate that our novel group-based intervention holds promise for women 
who experience these common and distressing, yet under-addressed symptoms and 

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propose to conduct an initial open pilot trial of our intervention to elicit feedback for 
future refinement efforts.   
 
3.0 Inclusion and Exclusion Criteria* 
3.1 Screening 
The study team will utilize the EHR (Epic) to screen potentially eligible survivors, as we 
have done for existing clinical and research programs. A clinical research coordinator 
(CRC) will review survivors’ EHR to ensure they meet the study eligibility criteria, with 
consultation from a study investigator or medical provider as necessary.  
3.2 Inclusion/Exclusion 
Inclusion Criteria 
1. Female sex 
2. English-speaking 
3. Aged 18 or older  
4. Receive any cancer care at MGH-CC sites (Boston, Waltham, Danvers, Newton 
Wellesley Hospital)  
5. Completed initial active treatment (i.e., surgery, radiation, chemotherapy) for 
colorectal or anal cancer approximately 3 months or more prior to enrollment or 
diagnosed longer than 3 months ago if in metastatic cancer treatment.  
 
Consistent with the National Comprehensive Cancer Network survivorship guidelines13 
and screening procedures previously implemented by our team (DF-HCC Protocol #22-
586), we will include female survivors of all ages endorsing sexual health concerns that 
negatively impact quality of life. Women on long-term endocrine therapies will not be 
excluded.  
 
Given the scientific aims of this study (i.e., addressing women’s sexual well-being), we 
are including only participants who identify their sex at birth as female and/or current 
gender identity as woman. Individuals who identify with all races and ethnic groups are 
eligible for this trial.  
 
Exclusion Criteria 
1. Active psychiatric or cognitive comorbidity that prohibits the capacity to provide 
informed consent as determined by the study PI, a licensed psychologist, in 
collaboration with the patient’s medical team 
2. Adults unable to complete study procedures in English. 
3. Adults who participated in the qualitative phase of this trial are not eligible for the 
pilot groups. 

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We are unfortunately unable to include individuals who are not fluent in English for this 
small open pilot trial, as the intervention content is currently only available in English 
(which is also the primary language in which our small study team is qualified to provide 
clinical services). We intend to prioritize broader inclusion of individuals who speak 
other languages in future larger-scale work.   
1.1 Special Populations:  
We will not enroll the following special populations: adults unable to consent, individuals  
who are not yet adults (i.e., < age 18), pregnant women, and prisoners. 
 
4.0 Study-Wide Number of Subjects* 
We will enroll up to 20 individuals, all recruited from MGH main campus and 
satellite sites, in this study. 
5.0 Study-Wide Recruitment Methods* 
N/A – this is a single site study. 
 
6.0 Multi-Site Research* 
N/A – this is a single site study. 
 
7.0 Study Timelines* 
We anticipate that participants will have approximately 4 months of active involvement. 
During this time, they will complete 6 approximately 1.5 hour approximately weekly 
group sessions as well as provide survey data and exit interviews. 
 
8.0 Study Endpoints* 
Primary aim: 
We will conduct a single-arm feasibility trial to examine the feasibility and acceptability 
of delivering a group-based mind-body sexual well-being intervention delivered via 
videoconference technology for up to 20 women who have completed treatment for 
colorectal or anal cancer. Specifically, we will assess whether a virtually-delivered, 6-
week sexual well-being group intervention for female colorectal and anal cancer 
survivors is: a) Feasible (assessed by evaluating recruitment/enrollment rates and 
adherence to sessions) and b) Well-accepted (defined by program satisfaction, ease and 
utility). Given the preliminary, open pilot nature of this protocol, we will not set a priori 
criteria to establish feasibility and efficacy but will rather interpret each of these metrices 
holistically. Qualitative feedback gathered in post-intervention exit interviews will also 
add to our understanding of feasibility and acceptability (see Table 1 below).  
Secondary aim: 

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We will explore the preliminary effects of the intervention on psychosocial measures of 
satisfaction with sex life and impact of functional limitations, coping abilities, acceptance 
of body image changes, loneliness, and anticipated stigma (see Table 1). As noted above, 
we will not set a priori criteria to establish preliminary efficacy, nor will we consider 
statistical significance as an indicator of study efficacy. Instead, we will consider pre-post 
intervention effect sizes to consider the need for refinement of study 
procedures/measurement in a future efficacy trial.  
 
We will complete the open pilot trial after completing 2 group intervention cohorts with 
approximately 10 participants per group. Primary outcomes of interest are listed below: 
 
Table 1. Measures for Open Pilot Data Collection  
Construct 
Measurement 
Data Source 
Feasibility 
 
 
Recruitment 
Percent screened of eligible 
patients identified 
Clinic logs (Epic) and recruitment tracking 
Screening/Eligibility 
Percent eligible of individuals 
screened 
Recruitment tracking log 
Enrollment 
Percent randomized of those 
eligible 
Recruitment tracking & randomization log 
Engagement 
(*) Percent completed 66% (4/6 
sessions) of those enrolled 
Session attendance logs 
Data Collection 
Percent with complete pre-post 
and post-session data 
REDCap tracker 
Acceptability 
 
 
Intervention 
(*) Overall comfort with 
intervention; satisfaction with 
virtual format; satisfaction with 
clinician; likelihood of 
recommending to others (1-5 
Likert scales). Content likes, 
dislikes, suggestions for 
improvement. 
Self-report in REDCap (1 item each); 
Qualitative exit interviews 
Assessments 
Ease of survey completion (1-5 
Likert scale). Experience of 
completing surveys & suggestions 
for improvement.  
Self-report in REDCap (1 item); 
Qualitative exit interviews 
Sociodemographic and Illness Characteristics (measured at baseline) 

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Sociodemographic 
background 
1. Cancer type(s); 2. Time since 
diagnosis; 3. Cancer staging; 4. 
Other cancer types; 5. Past 
treatment types; 5. Time since end 
of treatment (if applicable); 6. 
Ongoing or future cancer 
therapies 
Self-report in REDCap (7 items) 
Relevant illness 
information 
1. Sex assigned at birth; 2. 
Current gender identity; 3. Age in 
years; 4. Race; 5. Hispanic 
ethnicity; 6. Current relationship 
status; 7. Sexual orientation 
Self-report in REDCap (7 items) 
Exploratory Psychosocial Outcomes (all measured at baseline and post-intervention) 
Use of sexual health 
resources 
Single item questions querying 
use (ever, and # of visits) of: 1) 
MGH-CC Sexual Health Clinic; 
2) MGH-CC Fertility Center; 3) 
mental health services focused on 
sexual health and cancer; 4) 
pelvic PT; 5) sexual well-being 
discussion with member of main 
treatment team; 6) sexual well-
being discussion with other 
professional (please specify); 7) 
Online or written resource for 
sexual well-being and cancer 
(please specify); 8) Open-ended 
description of current concerns  
Self-report in REDCap (8 items) 
Positive Satisfaction 
with Sexuality 
(^) Sexual Satisfaction Scale for 
Women – Contentment subscale14  Self-report in REDCap (6 items) 
Impact of Functional 
Limitations to 
Sexuality 
NIH PROMIS SexFS – Bother 
Regarding Sexual Function 
(Female) subscale15, 16 
Self-report in REDCap (9 items) 
Coping Abilities  
Measure of Current Status- Form 
A (MOCS-A), relaxation and 
assertive social support-seeking 
subscales17 
Self-report in REDCap (5 items) 
Loneliness 
NIH Toolbox Adult Social 
Relationship Scales- Loneliness 
subscale18  
Self-report in REDCap (5 items) 

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Cognitive-Behavioral 
Acceptance of Body 
Changes 
Modified FACT/McGill Body 
Image Scale (FACT-MBIS)- Self-
Image subscale19 
Self-report in REDCap (11 items) 
Anticipated Stigma 
Modified chronic Illness 
Anticipated Stigma Scale- 
Healthcare workers subscale20 
4 items - REDCap 
Self-efficacy 
regarding sexual well-
being 
Single item-questions created for 
this study regarding 
understanding of: 1) cancer 
impact on sexual health; 2) 
communication strategies for 
sexual well-being; 3) use of 
relaxation strategies for sexual 
well-being; 4) impact of thoughts 
and feelings on sexual well-being; 
5) how to access appropriate 
resources for sexual well-being 
5 items - REDCap 
* Indicates primary measure of acceptability or feasibility; ^ Indicates primary effect size of interest  
 
 
 
 
9.0 Procedures Involved* 
 
This is an open pilot trial to gather initial data regarding feasibility, acceptability, and 
perceived impact of a 6-session mind-body group intervention that we are developing to 
enhance sexual well-being among post-treatment female colorectal and anal cancer 
survivors. Results of this open pilot will directly inform refinement of our study protocol, 
for ongoing testing in a future larger randomized pilot trial. A brief outline of the content 
that may be included in this intervention is below:  
 
Table 2. Overview of Anticipated Intervention Structure 
Topic Discussed 
Sexual Well-Being Target 
Session Content 
1. Defining Stress and 
Sexual Sequelae of 
Treatment 
Uncertainty about "normal" changes 
following treatment; education about stress-
sexuality connection 
1. Session ground rules and what to expect; 2. 
Effects of cancer treatment on sexual function; 3. 
Stress reactivity and relaxation response. 
2. Social Factors & 
Women's Sexual Well-
Being in Context 
Stigma and shame; difficulties 
communicating needs to medical providers 
and partners 
1. Social and cultural factors that influence 
women's sexuality; 2. Skills for assertive 
communication; 3. Overview of medical resources 
for sexual health (e.g., dilators, lubricants, 
moisturizers) and common barriers to use 

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3. Awareness of Thoughts 
and Feelings 
Unhelpful stress-related thoughts about 
sexuality that interfere with libido and 
health behaviors 
1. Mindful, nonjudgmental awareness of thoughts 
and feelings related to sexuality; 2. CBT strategies 
to challenge unhelpful thoughts; 3. Mindfulness as 
a resource to cultivate awareness of body 
sensations 
4. Body Image Changes 
Body image post-treatment and strategies to 
manage use of ostomy bag (if applicable) 
1. Self-compassion & body acceptance; 2. 
Barriers to (and facilitators of) health behavior 
engagement; 3. Introduction of guided imagery to 
cultivate pleasant experience 
5. Meditative Movement 
Pain/tightness and changes to physical 
sensation; reactivity to physical sensation 
1. Interoceptive awareness of body sensations; 2. 
Review of strategies for mindful non-judgment; 3. 
Gentle yoga/movement as a coping resource; 4) 
Behavioral activation and planning for pleasant 
physical sensations 
6. Meaning-Making of 
Change 
Personal values and goals for 
sexuality/intimacy; relapse prevention 
1. Personal values and meaning-making of 
change; 2. Review of goals for the future; 3. Use 
of art/creativity as a coping resource 
 
We will enroll approximately 10 women per group into 2 groups (total N ~ 20), based on 
logistic considerations and previous success with survivorship groups of a similar size. 
We will run groups consecutively so that any necessary changes from the first open pilot 
group may be incorporated and re-examined in the second. Based on participant feedback 
gathered in our qualitative study, we expect that groups will meet online via Zoom. 
Groups will be led by study PI Dr. Finkelstein-Fox, who has expertise in mind-body 
targets of illness adjustment, in collaboration with Co-I Dr. Drapek, who will lend 
expertise in medical aspects of sexuality in GI cancer survivorship. We expect that each 
of the 6 weekly sessions will last for approximately 90 minutes and include content 
related to mind-body medicine and complementary medical resources (e.g., dilators, 
lubricants, and moisturizers) relevant to survivors’ sexual well-being. The rationale for 
this treatment structure is based on our current survivorship resiliency groups, other 
cognitive behavioral sexual health interventions for cancer survivors and an existing brief 
nursing intervention for sexual health in GI oncology led by Dr. Drapek. During the open 
pilot, Dr. Park will provide clinical supervision of Drs. Finkelstein-Fox and Drapek 
and perform fidelity ratings of audio-recorded intervention sessions using checklists 
developed for the study. Drs. Bober and Psaros will also be available for clinical 
consultation. 
 
Participants will complete electronic informed consent prior to initiation of study 
procedures. To inform ongoing intervention refinement, we will ask participants to 
complete 15-minute survey batteries via REDCap at baseline and after the 6-session 
program, including assessments of intervention feasibility and acceptability as well as 
psychosocial outcomes including contentment with sex life, psychosocial impact of 
functional limitations, coping abilities, acceptance of body image changes, loneliness, 
and anticipated stigma (see Table 1 above). Measures have been selected for their 

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demonstrated strong psychometric properties in cancer populations, sensitivity to change, 
and brevity.  
 
Participants will also be invited to complete a brief qualitative exit interview with a 
member of our study team, regarding perceived benefit of the intervention as well as and 
strengths and weaknesses of program content and delivery format to inform ongoing 
intervention refinement (see script attached to this protocol). Participants will be offered 
up to $60 for participation in study assessments ($20 each for pre- and post- assessments 
as well as the qualitative exit interview). 
 
At the end of each session, the interventionist will complete an electronic process form 
indicating the length, location, and content of the session. We will also tally total number 
and timing of sessions attended for each participant. Attendance data will be logged in 
REDCap by a CRC. 
 
10.0 Data and Specimen Banking* 
N/A 
 
11.0 Data Management* and Confidentiality 
 
11.1 Data Analysis Plan 
 
Qualitative. Qualitative data coding and storage will be conducted using NVivo and/or  
coding matrices generated by our study team. We will use an audit trail to track data 
organization, coder strategy, and methods of discussion/interpretation for transparency  
and replicability. For the purposes of ongoing intervention refinement, qualitative data 
from open pilot trial participant exit interviews will be analyzed for themes related to 
participants’ experience in the program, perceived benefit, and suggested areas for 
improvement (see sample interview items attached to this protocol).  
 
Quantitative. Statistical significance will be considered as two-tailed p < .05. To explore 
feasibility of the adapted intervention, we will use descriptive statistics (i.e., frequency 
and percentages) to evaluate the proportion of enrolled participants who completed 4/6 
intervention sessions (75%). We will consider additional feasibility indices including 
those listed in Table 1. To establish acceptability, we will examine participant scores on 
an item querying overall comfort with group intervention. Our criteria for acceptability 
will require a Mean (or Median, depending on data distribution) score > 4 on a 1-5 Likert 
scale from 1 (not at all) to 5 (extremely). Other secondary criteria for acceptability are 
listed in Table 1. These data will be interpreted holistically together with qualitative 
feedback to identify areas for revision. 
 

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Effect Sizes (Exploratory).  Although the intent of this open pilot trial is not to perform a 
fully-powered hypothesis test,21 we will conduct exploratory analyses of strength of 
change (i.e., effect sizes) in our primary outcome (Positive Satisfaction with Sexuality; 
see Table 1). We will consider clinical improvements using within-person analysis of 
change from pre- (T0) to post-intervention (T1). Depending on model fit, mixed effect 
multivariable regression models may adjust for 1) time since end of treatment; 2) illness 
staging; and 3) age. Mixed effect multivariable models will be tested using the “lme4” 
package22  for R which allows for use of all available data.  
 
11.2 Sample size justification 
Following guidelines for pilot studies and exploratory mixed methods research, we have 
based sample size for this small proof-of-concept study (N = 2 groups with n ~ 10 
patients/group) on pragmatics and previous pilot research by our group21, 23 suggesting 
that this sample size will be sufficient to inform initial protocol refinement. 
 
11.3 Data Storage 
Participant data will be collected using REDCap and exit interviews saved on an MGB 
secure study folder. Data collected from participants will be kept confidential and 
accessible only to trained study staff. Participants will be assigned a study identification 
number, and all collected data will be stored securely with this identification number in 
files which do not include patient names or any other identifiable information. A link 
between names and identification numbers will be stored separately in a password 
protected file. All electronic data will be stored in password protected computer files. 
Any data files exported from the database will be de-identified, with only a case number 
identifying each participant, and no other identifying information.  
 
Dr. Finkelstein-Fox will oversee all aspects of data collection and will develop study 
specific data management protocol and standard operating procedures for the creation 
and testing of all study forms, data collection, quality control, and data extraction. She 
will provide ongoing oversight of data management throughout the study and will be 
responsible for generating reports and datasets for quality control and data analysis.  
 
We will comply with all requirements for data safety and monitoring, as specified by the 
IRB. As per Public Law 110-85, this is an applicable trial and will be registered and 
results reported with ClinicalTrials.gov. Dr. Finkelstein-Fox will be responsible for 
handling ClinicalTrials.gov requirements for this project. She will work closely with the 
Partners Human Research Affairs QI Program to register the trial prior to enrolling the 
first subject. Once a record is established, she will confirm accuracy of record content, 
resolve problems, and maintain records including content update and modification.  
 
11.4 Quality control of collected data 

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Dr. Finkelstein-Fox will train the study CRC in administration and data management of 
participant self-report questionnaires. The CRC will be responsible for conducting initial 
participant eligibility screening using clinic records in EPIC. The CRC will be closely 
supervised by Dr. Finkelstein-Fox in consultation with study Co-I Dr. El-Jawahri, who is 
a board-certified oncologist possessing the necessary expertise to oversee collection of 
patient clinical characteristics and oncology treatment information.  
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
N/A – this research involves minimal risk only. 
 
13.0 Withdrawal of Subjects* 
 
Should a participant experience an acute psychiatric or medical emergency that, in the 
clinical judgment of the study PI (a licensed clinical psychologist) and co-investigators 
(including licensed clinical psychologists, an oncologist, and an oncology nurse 
practitioner), makes it inappropriate or unsafe for them to continue participation in study 
procedures, we may ask them to withdraw from the study. Should this occur, the study 
investigators will provide referrals to meet their needs more appropriately. Non-clinical 
study staff will contact licensed clinical psychologists Dr. Finkelstein-Fox or Dr. Park in 
the case of any safety concerns and will provide appropriate mental health referrals or 
resources for supportive care at the MGH-CC as needed. If a participant requests 
withdrawal from the study, we will ask them if they are comfortable sharing the reason 
for withdrawal to ensure that there are no adverse events to report to the IRB.  
 
In the case that participants elect to withdraw from the study during the interview or 
group/treatment intervention, they will be invited to complete study surveys. Participants 
who are withdrawn at the discretion of the PI will be thanked for the participation and 
invited to complete study surveys as the PI deems necessary. 
 
Participants who provide electronic consent but do not complete study measures and/or 
withdraw or are removed from the study prior to participating in any intervention group 
sessions will not be counted towards the accrual goal up to 20 participants. We will keep 
a detailed log of these instances, as this will inform the feasibility of the study. 
 
All participants will be included in the feasibility assessment. We plan to examine the 
proportion of patients who are eligible and the proportion who are found to be ineligible 
due to inability to use the videoconferencing software, physician refusal, and medically 
or psychiatrically unable to participate. Out of those who are eligible, we will examine 
the proportion of enrollments, refusals, lost-to-follow up, withdraws, and study 
completers. We will examine reasons for and rates of ineligibility, as these will inform 

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the feasibility of the study and of delivering the program virtually. We will also examine 
the characteristics of non-completers and the reasons for non-completion. 
 
14.0 Risks to Subjects* 
The risks involved in the study are minimal and will be clearly delineated on the consent 
form. It is unlikely that participants will be at any risk for physical harm as a result of 
study participation. Confidentiality will be detailed on the consent form and discussed in 
detail so that participants are fully informed of their right to request information and to 
withdraw from the study at any time without impacting their care. We will also discuss 
the importance of maintaining confidentiality at the beginning of each intervention group 
to keep information shared confined to the group. Participants will also be made aware of 
the limits of confidentiality, including that confidentiality would be broken if participants 
reported thoughts of harming themselves or others, in order to obtain appropriate care for 
the participant. Participants may choose not to participate in the study or any of the study 
procedures without penalty. Those who do agree to participate may withdraw their 
participation at any time without penalty. 
 
Potential risks to participants are minimal across various study procedures and include 
the following: Questionnaire batteries. Participants may experience some discomfort 
answering questions on surveys; however, they may choose not to answer questions that 
are distressing. Group videoconferencing. Participants may have concerns about the 
security of videoconferencing and will be informed that the system is HIPPA compliant 
and sanctioned by MassGeneral Brigham HealthCare to protect privacy. Mind-Body 
Sexual Well-Being Groups. Participants might find some of the exercises (e.g., 
meditation/relaxation training, discussing concerns with fellow group participants) to be 
difficult or uncomfortable at first. These difficulties are typically minimal and temporary 
and are often a natural and valuable part of the treatment process.  
 
Procedures for Minimizing Risk 
All possible measures will be taken to ensure patient comfort and participants will be 
informed that they could exit the study at any point with no penalty. Lead investigators 
Dr. Finkelstein-Fox (a licensed clinical psychologists) will be available to intervene 
during study groups or assessment procedures if needed (due to patient discomfort or to 
answer specific questions about the study). Participants will be informed that they can 
choose not to answer any questions that make them feel uncomfortable. Every effort will 
be made to minimize the study burden. The time commitment will be explained to all 
participants prior to focus groups and qualitative interviews. All these procedures are 
consistent with sound research design and do not unnecessarily expose subjects to risk. 
If a participant expresses distress during the interviews, they will be reassured by the 
clinician or study staff member conducting the interview that they can stop at any time 
and that they do not need to continue participating in content or answer interview 

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questions which they find upsetting. They will also be reminded that study participation 
is voluntary. If participants remain distressed, they will be offered an opportunity to meet 
with a psychologist in the Psychiatric Oncology Service at the MGH Cancer Center to 
help address their distress. If the patient needs further outpatient services for depression, 
including pharmacotherapy, or is at risk for self-harm requiring hospitalization, study 
staff will make the necessary referrals for treatment. For example, for patients who are 
distressed but in no danger to self or others, study staff will refer either to the MGH 
Oncology Social Work Service or to the MGH Outpatient Psychiatry Department (617-
724-5600), including the Cognitive-Behavioral Therapy Program. If suicidality or risk of 
harm to others is otherwise discovered at any study visit, the participant will be referred 
to appropriate services. Specifically, in the case that hospitalization is required, study 
staff will contact and escort the patient to the MGH Acute Psychiatry Service (617-726-
2995), with the aid of the MGH Police & Security if necessary (617-726-2121). If a 
referral for outpatient services is made, or the patient requires escort to the MGH Acute 
Psychiatry Service, study staff will notify the health care team, including the primary 
oncologist. 
The PI and trained study staff will meet weekly to review study progress, ensure properly 
implementation of the interview, and review any adverse reactions that occur. The PI and 
the research assistant will review consents and collected data to ensure proper adherence 
to study protocol. 
 
15.0 Potential Benefits to Subjects* 
 
We do not know if taking part in this open pilot study will benefit participants. This study 
may help researchers learn how to help women experiencing changes to sexual well-
being following treatment for colorectal and anal cancer in the future. However, the risk 
from participation in the study is small (and will be minimized by the procedures outlined 
above), and the overall risk to benefit ratio is favorable. 
 
 
16.0 Vulnerable Populations* 
N/A 
 
17.0 Community-Based Participatory Research* 
N/A 
 
18.0 Sharing of Results with Subjects* 
Given the nature of the population included in the study, it is not appropriate to 
proactively contact participants at the conclusion of this study. However, we provide the 

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research team contact information to each participant and encourage them to contact us if 
they would like to receive updates and information on the research findings. 
 
19.0 Setting 
The study will include cancer survivors treated at the Massachusetts General Hospital. 
Participants will be approached for participation in-person, phone or email, or via patient 
gateway. The intervention will be delivered via a virtual-HIPPA-compliant 
videoconferencing technology, Zoom, that is accessible via smartphone, laptop, tablet, or 
desktop. All participants will also be invited to complete an exit interview that will be 
conducted virtually or in person. 
 
20.0 Resources Available 
 
20.1 Study Team Qualifications. Prior to working on any human subject aspects of the 
study, all study staff will complete the required human subjects training. No identifying 
information will be kept on any study forms. The study CRC will be responsible for 
assigning unique study IDs and for maintaining a log that links participant names with 
their unique study identifier; this log will be password-protected, kept separate from 
study information and stored in a study network folder which is backed up nightly. All 
data collected will be stored with this identifier. Electronic data will be kept confidential, 
stored in secure servers, password-protected and protected by anti-virus software, and 
accessible only to trained and IRB-approved study staff. 
 
Study staff will also be required to undergo human subjects training prior to engaging in 
any research activities. The CRC will have regular meetings with the study PI to review 
accrual, retention, attrition, and data completeness.  
 
20.2 Other Relevant Resources. Drs. Finkelstein-Fox, Park, and El-Jawahri are 
members of the MGH Cancer Outcomes Research and Education Program (CORE). 
CORE has extensive experience conducting randomized clinical trials of supportive care 
interventions in oncology and has the necessary expertise to ensure the success of the 
proposed project. Drs. Finkelstein-Fox, Park, and El-Jawahri are also members of the 
MGH Health Promotion and Resiliency Intervention Research Program, which houses 
expertise and research staff focused on mind-body interventions. We will also have 
relevant resources from the MGH Behavioral Medicine Program, of which Drs. 
Finkelstein-Fox, Park, and Psaros are members, and the MGH Cancer Center Sexual 
Health Clinic, of which Dr. Drapek is the Director. 
 
21.0 Prior Approvals 
Funding is provided by the Harvard Osher Center. No additional approvals are required.  

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22.0 Recruitment Methods 
 
We will recruit participants by reviewing patient clinic records on Epic and conducting 
proactive outreach, as well as via physician and patient self- referral from the MGH-
Cancer Center. Specific recruitment methods are outlined below. 
 
22.1 Eligibility Pre-Screening in Epic. All patients will be pre-screened for eligibility 
prior to contact using clinic records in Epic (see request for HIPAA Waiver below). 
Eligible patients will then be contacted by the study team to complete eligibility phone 
screening (see script attached to this protocol). Eligible and interested patients will then 
be directed to complete the informed consent process via electronic consent in REDCap 
(see consent form attached to this protocol). 
 
We are requesting a HIPAA Waiver of Authorization to Review Preparatory to Research 
from the IRB. We are requesting this Waiver to identify potential patient participants from 
a minimal chart review. In accordance with the DF/HCC policy, this Waiver: (1) is being 
sought solely to review Protected Health Information as necessary to prepare a research 
protocol, (2) will not include removing Protected Health Information from the Covered 
Entity by the researcher, and (3) is necessary for the research purposes. 
 
Epic Screening and Proactive Outreach. Following Epic screening, we will communicate 
with a qualified oncology clinician via email, through the electronic health record, or 
verbally to notify them that the patient is eligible for the study and inquire about any 
concerns regarding their participation. If the oncology clinicians have objections to the 
patients’ participation in the study, we will document the reason and not approach those 
individuals. If the oncology clinicians have no objections or does not respond within 5 
business days, the CRC will approach the potentially eligible patient to invite them to 
participate in the study and review the nature of all study procedures. The CRC can 
approach the survivor in-person during a medical visit or over the telephone/video call to 
perform initial eligibility screening and begin the informed consent process. Reasons for 
refusal and ineligibility will be documented. 
 
22.2 Provider Referral and Patient Self-Referral. We have developed a study flyer that 
clinicians may share with potentially eligible patients to facilitate direct patient outreach. 
Participants recruited via direct referrals from their providers may either contact study 
staff directly using the information their provider gave them (see attached flyer), and/or 
the provider will contact the study team with the patient’s information so that the study 
team may reach out to the patient.  
 
22.3 ONCORE Registration of Eligible Participants. We will register eligible 
participants in the Clinical Trials Management System (CTMS) Oncore as required by 

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DF/HCC SOP REGIST-101. Registration must occur prior to the initiation of protocol-
specific procedures or assessments. For registration of patients, study staff will complete 
the DF/HCC protocol-specific eligibility checklist using the eligibility assessment 
documented in the participant’s medical record and/or research chart. Study staff will 
confirm that the participant meets all inclusion criteria as described in this protocol and the 
criteria on the eligibility checklist.  
 
22.4 Strategies for Recruitment of Diverse Participants.  For this small proof-of-
concept open pilot trial, we will make every effort to recruit individuals whose 
sociodemographic characteristics mirror the characteristics of individuals with colorectal 
and anal cancer in the general population. Based on our earlier qualitative research 
project recruiting a similar patient population (DFCI IRB #22-586), we anticipate that 
efforts to enhance diverse participation may be especially important for non-Hispanic 
Black individuals and those with lower socioeconomic status. To prioritize inclusion of 
individuals, we will use strategies previously employed by our group, including outreach 
to MGH-CC satellite sites and use of inclusive language/images on our study recruitment 
materials. Sociodemographic inclusion will also be a focus of future larger-scale trials to 
continue refinement of this work. 
 
22.5 Remuneration. Participants who complete all study procedures may receive up to 
$60 remuneration via gift cards ($20 for pre-program survey, $20 for post-program 
survey, $20 for exit interview). 
 
23.0 Local Number of Subjects 
We expect to enroll up to 20 participants in the study protocol. Participants will 
not complete the full signed informed consent (i.e., enrollment) until they have 
completed an initial eligibility screening and confirmed interest in participating to 
the study CRC.  
24.0 Provisions to Protect the Privacy Interests of Subjects 
 
During the initial informed consent procedure, eligible individuals will be told that 
participating in the research study is voluntary, and that they are able to withdraw at any 
point with no penalty or loss of benefits to them. Given the sensitive nature of the study 
topic, we will also remind participants that they are not required to answer any question 
that makes them uncomfortable, nor are they required to participate in any study 
procedure that makes them uncomfortable.  
 
The study will be monitored by the investigative team. As described in section above, to 
safeguard participant information and confidentiality, all data will be stored in locked 
office space at MGH as well as in password-protected computer files, accessible only to 

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trained and IRB-approved study staff. Participants' data will be identified by an ID 
number only, and a link between names and ID numbers will be kept separately under 
lock and key or in a separate password protected document accessible only by study staff. 
Data identified by ID numbers may also be stored in REDCap, a secure, web-based 
application designed to support data capture for research studies. 
 
Transcripts of all exit interviews will be de-identified, and participants will be directed to 
avoid using personal identifiers (i.e., birthdays, home address, full names) during the 
interview, thus maintaining patient anonymity and confidentiality during the interview. 
Audio- records of these interviews will be uploaded to our study access-restricted drive. 
Interviews will either transcribed directly by research study staff or be sent securely and 
transcribed by transcribeme.com. 
 
25.0 Compensation for Research-Related Injury 
N/A – this study does not involve more than minimal risk. 
 
26.0 Economic Burden to Subjects 
N/A – participants are not expected to incur any costs because of participation in this 
research. 
 
27.0 Consent Process 
27.1 Initial Phone Eligibility Screening. We request a waiver of signed informed 
consent for our initial study phone screening process (see phone screen script attached to 
this protocol). In the attached phone screening document, we ask participants to provide 
verbal consent for initial phone-screening to confirm study eligibility. If study eligibility 
is confirmed during phone screening, participants will be invited to provide informed 
consent for the study (process described below).  
 
27.2 Informed Consent for Study Participation (e-consent or signed paper form). 
Participants will be asked during the initial phone screening phase whether they prefer to 
complete the study consent forms electronically vs. in person. We will also ask 
participants about their preference for encrypted (our default option) or unencrypted 
email during this screening call; their preference will be documented and used to inform 
means of future outreach.  
For those who prefer an in-person consent procedure, we will schedule a brief in-person 
appointment with a member of our research team, who will review the consent form with 
the participant in detail, answer any questions, sign, and provide a photocopy of the 
signed consent form to the participant for their records.  
 

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For those who prefer an electronic copy of the consent form, we will schedule a brief 
phone appointment with a member of our research team. Following the MBG RedCap e-
consent form template, study staff will fill out the first survey in the template (i.e., date of 
birth, name, and email of participant). RedCap will automatically email the participant a 
link to a RedCap survey in which they can read the consent form. To access the form, 
participants are required to input their birthdate. The consent form will be identical to the 
paper version (no hyperlinks or additional information available). During the phone 
appointment, research staff will review the consent form with the participant as is done in 
the in-person procedure, answering any questions as they arise. While on the phone with 
our research staff, participants will provide electronic consent in REDCap. Participants 
will always have the option to end, pause, or review any part of the consent process 
according to their preference during this phone call with study staff. After the participant 
has signed the consent form, the consenting study team member will sign the form and 
download a copy to send to the participant. Any email correspondence containing a 
signed study consent form will be sent with encrypted email, unless participants directly 
state a preference for unencrypted email. Our study team will also download and save a 
signed copy of all e-consent forms to our research files. REDCap automatically captures 
a timestamp containing time/date of e-consent signature. 
 
28.0 Process to Document Consent in Writing 
 
As described above, the CRC will conduct informed consent procedures with eligible 
potential participants and obtain electronic consent. Signed copies of the electronic 
consent form will be saved to the study server and emailed to each study participant for 
their records. If participants prefer a paper consent form (signed in-person), we will scan 
and save an electronic copy of the consent form to our server as well as save the original 
signed copy in a locked file cabinet in the PI’s office.  
 
29.0 Drugs or Devices 
N/A 
 
 
 
 
 
 
 
 
 
 

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1. 
National Cancer Institute Survey Epidemiology, & End Results (SEER) Program. 
Cancer of the colon and rectum - cancer stat facts. 2022 [January 28, 2022]. Available 
from: https://seer.cancer.gov/statfacts/html/colorect.html. 
2. 
National Cancer Institute Survey Epidemiology, & End Results (SEER) Program. 
Cancer of the anus, anal canal, and anorectum - cancer stat facts. 2022 [January 28, 
2022]. Available from: https://seer.cancer.gov/statfacts/html/anus.html. 
3. 
American Cancer Society. Colorectal cancer facts & figures 2020-2022. Cancer 
Facts and Statistics. 2022 [January 28, 2022]. Available from: 
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-
statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-
2022.pdf. 
4. 
El-Shami K, Oeffinger KC, Erb NL, Willis A, Bretsch JK, Pratt-Chapman ML, 
Cannady RS, Wong SL, Rose J, Barbour AL, Stein KD, Sharpe KB, Brooks DD, 
Cowens-Alvarado RL. American Cancer Society Colorectal Cancer Survivorship Care 
Guidelines. CA Cancer J Clin. 2015;65(6):428-55. Epub 20150908. doi: 
10.3322/caac.21286. PubMed PMID: 26348643; PMCID: PMC5385892. 
5. 
Ramirez M, McMullen C, Grant M, Altschuler A, Hornbrook MC, Krouse RS. 
Figuring out sex in a reconfigured body: experiences of female colorectal cancer 
survivors with ostomies. Women Health. 2009;49(8):608-24. doi: 
10.1080/03630240903496093. PubMed PMID: 20183104; PMCID: PMC2836795. 
6. 
Den Oudsten BL, Traa MJ, Thong MS, Martijn H, De Hingh IH, Bosscha K, van 
de Poll-Franse LV. Higher prevalence of sexual dysfunction in colon and rectal cancer 

PROTOCOL TITLE: Open Pilot Trial of a Mind-Body Sexual Well-Being Program  
 
 
 
 
Page 21 of 22 
 
 
 
 
survivors compared with the normative population: a population-based study. Eur J 
Cancer. 2012;48(17):3161-70. Epub 20120517. doi: 10.1016/j.ejca.2012.04.004. PubMed 
PMID: 22608772. 
7. 
Acquati C, Hendren S, Wittmann D, Reese JB, Karam E, Duby A, Dunn KB, 
Kayser K. Psychological and sexual distress in rectal cancer patients and partners. 
Psychooncology. 2022;31(6):920-8. Epub 20220120. doi: 10.1002/pon.5880. PubMed 
PMID: 35001478. 
8. 
Traa MJ, De Vries J, Roukema JA, Den Oudsten BL. Sexual (dys)function and 
the quality of sexual life in patients with colorectal cancer: a systematic review. Ann 
Oncol. 2012;23(1):19-27. Epub 20110420. doi: 10.1093/annonc/mdr133. PubMed PMID: 
21508174. 
9. 
Wo JY, Drapek LC, Niemierko A, Silvia B, Noe BN, Russo AL, Miyamoto DT, 
Hong TS, Efstathiou JA, Zietman AL, Dizon DS. Clinical needs assessment for sexual 
health among cancer patients receiving pelvic radiation: Implications for development of 
a radiation oncology sexual health clinic. Pract Radiat Oncol. 2018;8(3):206-12. Epub 
20171121. doi: 10.1016/j.prro.2017.11.004. PubMed PMID: 29426693. 
10. 
da Silva GM, Hull T, Roberts PL, Ruiz DE, Wexner SD, Weiss EG, Nogueras JJ, 
Daniel N, Bast J, Hammel J, Sands D. The effect of colorectal surgery in female sexual 
function, body image, self-esteem and general health: a prospective study. Ann Surg. 
2008;248(2):266-72. doi: 10.1097/SLA.0b013e3181820cf4. PubMed PMID: 18650637. 
11. 
Drapek LC CM, Sheldon LK, Wo, J. A Multimodal Continuity of Care Program 
to Prevent or Minimize Vaginal Effects of Pelvic Radiation therapy in Women with 
Lower Gastrointestinal or Gynecologic Cancers.  Oncology Nursing Society- Annual 
Congress; Washington, DC2018. 
12. 
Drapek LC NB, Hong TS, Dizon DS, Wo JY. . Longitudinal Follow-up of 
Women Receiving Pelvic Radiotherapy for Gynecologic and Lower GI or Gynecologic 
Cancers.  American Society of Therapeutic Radiation Oncology (ASTRO)-Annual 
Conference; Chicago, IL2019. 
13. 
Denlinger C, Sanft T, Baker K. Survivorship, Version 2.2018, NCCN Clinical 
Practice Guidelines in Oncology 2018 [cited 16]1216-47]. 
14. 
Meston C, Trapnell P. Development and validation of a five-factor sexual 
satisfaction and distress scale for women: the Sexual Satisfaction Scale for Women (SSS-
W). J Sex Med. 2005;2(1):66-81. doi: 10.1111/j.1743-6109.2005.20107.x. PubMed 
PMID: 16422909; PMCID: PMC2859306. 
15. 
Flynn KE, Lin L, Cyranowski JM, Reeve BB, Reese JB, Jeffery DD, Smith AW, 
Porter LS, Dombeck CB, Bruner DW, Keefe FJ, Weinfurt KP. Development of the NIH 
PROMIS (R) Sexual Function and Satisfaction measures in patients with cancer. J Sex 
Med. 2013;10 Suppl 1:43-52. doi: 10.1111/j.1743-6109.2012.02995.x. PubMed PMID: 
23387911; PMCID: PMC3729213. 
16. 
Flynn KE, Reeve BB, Lin L, Cyranowski JM, Bruner DW, Weinfurt KP. 
Construct validity of the PROMIS(R) sexual function and satisfaction measures in 

PROTOCOL TITLE: Open Pilot Trial of a Mind-Body Sexual Well-Being Program  
 
 
 
 
Page 22 of 22 
 
 
 
 
patients with cancer. Health Qual Life Outcomes. 2013;11:40. Epub 20130311. doi: 
10.1186/1477-7525-11-40. PubMed PMID: 23497200; PMCID: PMC3618202. 
17. 
Carver CS. Measure of current status 2006 [November 11, 2021]. Available from: 
https://local.psy.miami.edu/people/faculty/ccarver/availbale-self-report-
instruments/mocs/. 
18. 
Cyranowski JM, Zill N, Bode R, Butt Z, Kelly MA, Pilkonis PA, Salsman JM, 
Cella D. Assessing social support, companionship, and distress: National Institute of 
Health (NIH) Toolbox Adult Social Relationship Scales. Health Psychol. 
2013;32(3):293-301. doi: 10.1037/a0028586. PubMed PMID: 23437856; PMCID: 
PMC3759525. 
19. 
Rodriguez AM, Frenkiel S, Desroches J, De Simone A, Chiocchio F, MacDonald 
C, Black M, Zeitouni A, Hier M, Kost K, Mlynarek A, Bolster-Foucault C, Rosberger Z, 
Henry M. Development and validation of the McGill body image concerns scale for use 
in head and neck oncology (MBIS-HNC): A mixed-methods approach. Psychooncology. 
2019;28(1):116-21. Epub 20181112. doi: 10.1002/pon.4918. PubMed PMID: 30312500. 
20. 
Earnshaw VA, Quinn DM, Kalichman SC, Park CL. Development and 
psychometric evaluation of the Chronic Illness Anticipated Stigma Scale. J Behav Med. 
2013;36(3):270-82. Epub 20120413. doi: 10.1007/s10865-012-9422-4. PubMed PMID: 
22526525; PMCID: PMC4370181. 
21. 
Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, 
Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From 
ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic 
diseases. Health Psychol. 2015;34(10):971-82. Epub 20150202. doi: 
10.1037/hea0000161. PubMed PMID: 25642841; PMCID: PMC4522392. 
22. 
Bates D, Mächler M, Bolker B, Walker S. Fitting Linear Mixed-Effects Models 
Using lme4. Journal of Statistical Software. 2015;67(1):1 - 48. doi: 
10.18637/jss.v067.i01. 
23. 
Hall DL, Yeh GY, O'Cleirigh C, Peppercorn J, Wagner LI, Denninger J, Bullock 
AJ, Mizrach HR, Goshe B, Cheung T, Li R, Markowitz A, Park ER. A Multi-step 
Approach to Adapting a Mind-Body Resiliency Intervention for Fear of Cancer 
Recurrence and Uncertainty in Survivorship (IN FOCUS). Glob Adv Health Med. 
2022;11:21649561221074690. Epub 20220127. doi: 10.1177/21649561221074690. 
PubMed PMID: 35237466; PMCID: PMC8883302.