Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being
Phase: NA
Conditions: Breast Cancer, Gynecologic Cancer
Sponsor: Oregon State University

 
 
 
 
PI: Jessica Gorman 
Abbreviated Title: Mindful After Cancer Study 
 
IRB # 2019-003 
 
 
 
Protocol Title 
Mindful After Cancer Study: Fostering positive body image, sexual health, and well-being 
Principal Investigator 
Jessica R. Gorman, PhD, MPH 
Sponsor 
Oregon Health and Sciences University 
Knight Community Partnership Program 
 
Version date: 08/17/2020 
 
NCT04559854 
 
 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
 
1.0 Study Objectives .................................................................................................................................... 4 
2.0 Background ........................................................................................................................................... 4 
3.0 Research Procedures ............................................................................................................................. 4 
4.0 Inclusion and Exclusion Criteria ......................................................................................................... 6 
5.0 Risk to Participants and Risk Mitigation ........................................................................................... 6 
6.0 Potential Benefits to Participants ........................................................................................................ 7 
7.0 Cost to Participants ............................................................................................................................... 7 
8.0 Recruitment Process ............................................................................................................................. 7 
9.0 Screening and Consent process ............................................................................................................ 8 
10.0 Compensation ...................................................................................................................................... 8 
11.0 Data Management ............................................................................................................................... 9 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 Study Objectives 
The study aims are to: 1) Assess the feasibility of the MAC program when delivered via 
videoconference and 2) Assess preliminary effects of the program. The long-term goal is to 
establish a strategy for program sustainability, and to improve quality of life for 
breast/gynecologic cancer survivors in Oregon. 
2.0 Background 
The inspiration for this project stemmed from the unmet sexual health-related needs and 
concerns expressed by the local cancer survivor community, which resulted in a partnership 
between OSU and Samaritan Cancer Resource Center to begin filling this gap. Our community’s 
concerns were not surprising given that the sexual health consequences of cancer are among the 
most common and distressing aspects of survivorship. All participants in our prior pilot trial 
were experiencing clinical levels of sexual distress and dysfunction. Overall, at least half of 
breast and gynecologic cancer survivors experience sexual health difficulties. Concerns extend 
beyond the capacity to have sexual intercourse, and encompass physical, psychological, and 
social aspects related to physical discomfort, low desire, mood, body image, and worries about 
partners’ satisfaction. Tools such as lubrication and dilators can help with physical challenges, 
but the emotional and social aspects are equally critical, and all aspects are addressed in this 
program. Importantly, when sexual health concerns are left unaddressed, there is a negative 
impact on partner relationships and quality of life well after cancer treatment ends. 
 
In the earlier phase of this study, we made initial adaptations to an evidence-based intervention 
based on cancer survivor and stakeholder feedback. There is evidence that the prior version of 
the intervention (MIND) improves sexual function among women in the general population, and 
we made adaptations to the content to meet the needs of women who had survived cancer. We 
conducted interviews with the target audience to understand their characteristics, experiences, 
attitudes, needs, and potential facilitators and barriers to their participation in the intervention. As 
part of the iterative adaptation process, following the ADAPT-ITT model, we pre-tested the 
newly adapted intervention with a group of female cancer survivors. Data from this first phase of 
research provided evidence for feasibility and acceptability, as well evidence of the intervention's 
capacity to improve sexual and psychosocial health outcomes for female cancer survivors. This 
process also resulted in adaptations to make the program easier for the facilitator to deliver and 
participant materials tailored to the needs and concerns of cancer survivors. Results pointed 
toward the potential of a videoconference-based delivery mechanism to help overcome barriers 
associated with time/travel, privacy concerns, and preference for receiving the intervention in 
home or community settings (vs. a cancer care setting). The current phase of research will build 
on this prior work to further optimize the intervention for breast and gynecologic cancer 
survivors and to increase the reach of this intervention to survivors across Oregon. This work has 
occurred in consultation with the original developer of the materials. 
 
3.0 Research Procedures 
Intervention with pre-post assessment and follow-up qualitative interview with sub-group. 
 

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The 8-week intervention will be offered for 15-25 survivor participants per group via 
videoconference across 2 different cohorts. A trained facilitator will deliver the intervention by 
following a detailed manual. Participants will have companion handouts and activities for in 
session activities and home activities. Each weekly session is 1.5-2 hours long. Participants will 
connect via videoconference from a private location via their computer, tablet or smart phone. 
Participants may either connect using a video camera if they choose to, or they may choose to 
interact using only audio. Prior to the start of the program, we will provide tutorial information 
about use videoconference software and a phone number to call in case of technical difficulties. 
We will also mail each participant a hard copy of all participant materials, which include home 
activities and educational materials. Each week, we will provide them with an audio-recorded 
meditation to use at home. 
 
At the end of each session, the facilitator will remind participants that they can reach out to her 
between sessions if needed, and how to reach her (e.g., email, phone). She will also remind 
participants of the online and telephone-based resources available to them should they need extra 
support between sessions. Participants who are experiencing difficulty will be encouraged to 
seek support via professional counseling/therapy and/or a support group. Participants will be 
asked to complete weekly tasks (e.g., guided meditation, homework activities) as part of the 
invention. Data from these tasks will not be analyzed for purposes of this study. 
 
All participants will receive a Qualtrics link after enrolled, and prior to the start of the 
intervention, so that they can complete an online baseline survey. They will receive a second link 
to complete an online survey 1-month after the intervention ends. Surveys will evaluate 
acceptability, credibility, and changes in sexual function, psychosocial health, relationship 
outcomes, well-being, and sex-related distress.  
 
To evaluate quantitative data, we will use a dependent groups t-test or Wilcoxon test to compare 
mean/median scale scores (pre- and post-test) for each outcome assessed. Our focus for this 
study is on the feasibility and acceptability of the intervention, and implementation using a 
videoconference format. With the small sample size, we do not anticipate having sufficient 
power to detect pre-post changes in outcomes.  
 
Sampling strategy for qualitative interviews: We will use purposeful sampling to select 10 
participants that represent maximum variation. We will purposefully invite women who are 
reproductive-aged and post-menopausal, breast and gynecological cancer survivors, women who 
identify as white and non-white race, and women who identify as heterosexual and non-
heterosexual. We expect this strategy to yield representativeness and diversity in the sample, and 
to improve documentation of the potential variations and common patterns (e.g., needs, 
preferences) that cut across cases. 
 
This will allow us to gain valuable knowledge about participants’ experiences with the 
intervention, in behavior, facilitators of change, barriers to change, additional intervention 
modifications, and the context and meaning for any perceived changes in sexual function, 
psychosocial health, relationship outcomes and other outcomes of interest. Eliciting the 
experiences of participants through in-depth post-intervention interviews will improve our 
understanding of how the intervention works. 

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We will transcribe post-intervention interviews and will use cross-case, inductive analysis to 
analyze responses and identify themes and patterns in the qualitative data. To enrich our 
understanding of the program’s impact, we will consider quantitative results within the context 
of qualitative findings. 
 
Participant intervention sessions will be audio recorded for review and assessment of fidelity of 
intervention delivery. This is required for participation. Post-program qualitative interviews will 
be audio recorded for later transcription to ensure the collection of accurate interview data. 
 
In all cases, participants must agree to audio-recording in order to participate. They may choose 
not to answer any of the questions. They may choose to end the interview or leave an 
intervention session at any time. Audio recording is necessary for the collection of accurate 
interview data and for the assessment of fidelity (delivery of the intervention as outlined in the 
protocol). In the case that a participant initially agrees to audio recording an interview and 
requests that the recording is stopped before completing the entire interview, the interview will 
be terminated but the interview data to that point will be included in the study. 
4.0 Inclusion and Exclusion Criteria 
4.1 Inclusion Criteria 
Adult female breast/gynecologic cancer survivors| This group experiences a direct, 
negative impact on their reproductive systems, leading to concerns about body image and 
sexual function. We focus on females because their sexual concerns are distinct from and 
more poorly addressed than males’ concerns. 
 
Diagnosis 1 or more years prior and completed primary cancer treatment. Research 
indicates that post-treatment cancer survivors are at highest risk of sexual health concerns. 
Participants in our pilot trial also confirmed that this group would benefit most from the 
intervention.  
 
Have access to a computer, smart phone, or tablet with internet access. This is required for those 
who to be eligible to participate in the program. 
 
Ability to spend 15-30 minutes daily on program activities | This was determined to 
be feasible in the first phase of research, and will be sufficient to complete required intervention 
activities. 
 
 
4.2 Exclusion Criteria 
Cancer stage: Stage 0 cancer (carcinoma in situ) is excluded.  
5.0 Risk to Participants and Risk Mitigation 
The risks involved in this study are minimal, and consist principally of the possible stress or 
embarrassment produced by responding to questions during individual interviews, surveys, or 

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while participating in the intervention sessions. All participants will be assured that they may 
refuse to answer any question and can choose not to participate in any study activity. There may 
be psychological distress associated with talking about sexual health or distress caused by 
participating in a program that brings up sensitive topics to cancer survival and sexual health. 
Based on our past experiences using these same procedures, the likelihood of and seriousness of 
these risks to participants is minimal. 
 
The PI and study team members will be sensitive to the fact that participants could be upset 
because of the topics being discussed. The PI will make sure that the research assistants 
receive training in communication on sensitive issues and will be respectful of participants to 
minimize any potential stress.  
 
During interviews, participants may choose not to answer any questions or participate in any 
aspect of the discussion that they are uncomfortable with. Participants may ask for the recording 
to be stopped at any time. If during an interview a participant appears particularly uncomfortable 
or stressed, the interviewer will remind the participant that she/he does not have to answer the 
question. For all surveys, participants may choose not to answer any question. 
 
During the intervention, participants may choose not to engage or participate in any aspect of the 
program (e.g., activity, discussion), may leave a session early, and may choose not to attend 
sessions. Because of the sensitive subject matter, we will provide a listing of “Helpful 
Resources” to all cancer survivor participants as part of the informed consent procedure. 
6.0 Potential Benefits to Participants 
There are no known benefits to participating in the study, although participants in the 
intervention may experience benefits to their sexual and mental health. Our pilot test data 
provided promising results, including improvements in sexual and mental health outcomes. For 
all participants, there is a societal benefit of contributing toward an improved understanding of 
what helps women who have survived cancer to improve their sexual health and quality of life. 
7.0 Cost to Participants 
Participation in this study requires no cost to participants, aside from time, telephone use, and 
Internet use. 
8.0 Recruitment Process 
 
We will invite participants via social media and community-based outreach via community 
partners across Oregon. We will invite community partners (e.g., non-profit organizations, 
clinics, social services, advocacy organizations) to post flyers describing our project. Interested 
individuals will be asked to contact study personnel for more information and to determine their 
eligibility. 
 
 

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9.0 Screening and Consent process 
Study staff will describe the study to potential participants over the telephone, and will clearly 
present the eligibility criteria to potential participants and then ask if they are still interested in 
participating. After obtaining written informed consent to participate, study staff will confirm 
eligibility criteria and schedule interviews and other study activities. We will retain de-identified 
screening data for all potential participants so that we can report the number of screened, 
eligible, and enrolled participants by demographic. 
 
Cancer survivors who are recruited to participate in the 8-week program will be required to 
review and sign the written consent form prior to completing any study activities (e.g., surveys or 
program meetings). A copy of the signed informed consent will be provided to study 
participants. Consent forms will be reviewed over the telephone. Each participant will be mailed 
or emailed the consent form for their signature and it will be returned via mail or in person to 
study staff prior to completing any study activities. 
 
Those with diminished capacity to consent will not be enrolled. The capacity to consent is 
initially judged by the study staff at the time of enrollment based on the person’s ability to 
understand the research process as demonstrated during the initial description of the study and 
their ability to engage in the informed consent discussion. Those with limited ability to engage in 
the informed consent discussion or limited comprehension of the study requirements will not be 
enrolled. To assist in determining comprehension, interviewers will ask, “What questions can I 
answer for you?” 
 
Participants will be asked in the consent form if they are willing to be contacted about future 
research studies. They can answer yes or no. Participants may also request that we stop 
contacting them at any time. Participants will not be contacted in the future for the sole purpose 
of updating information. 
 
The consent form will notify participants that we will keep de-identified data from the study 
indefinitely. Data will be stored electronically without any personal identifying information and 
will only be accessible to study personnel. Keeping data will allow us to continue to 
answer new research questions that may arise and to compare these results to those of future 
studies. The consent form includes information about how to withdraw from the study, and how 
to withdraw study data. 
10.0 Compensation 
Aim 1. Intervention Assessments 
Participants in the intervention will receive $20 upon completion of the pre-program survey and 
$20 upon completion of the post-program survey. 
 
A sub-group of 10 intervention participants will receive $30 for participating in a follow-up 
qualitative telephone interview.  
 

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11.0 Data Management 
All participants will be assigned a study-specific identifier. An electronic database file linking a 
participant to her/his study identifier will be maintained in a password-protected database that 
can be accessed only by the investigators and study staff. Personal identifiers will be stored 
securely by study personnel at OSU and retained for future study recruitment. 
 
Potential risks related to the loss of confidentiality will be handled by restricting access to 
audio-recordings, electronic files, and paper files to designated study personnel. All project data 
(digital, audio, paper) will be maintained at OSU in locked file cabinets and/or on a password 
protected computer with fully patched operating systems and applications and current antivirus 
software with current virus definitions in the locked offices of the PI and trained project staff at 
OSU. Data will be stored for a minimum of three years after study termination. A plan for 
routine back-ups is in place. 
 
In written reports and publications, including information shared funders, personal information 
and identifiers will not be linked to the data. For example, publications may include direct quotes 
but will only attach a general description of the participant to the quote, such as “breast cancer 
survivor.” We will not use participant names or other information that could identify them 
personally in reports and publications. 
 
A link between study code numbers and direct identifiers will be retained until analyses are 
complete, and results have been disseminated via publications and reports. This will allow us to 
verify details if needed (e.g., if there is a discrepancy or missing data). Audio recordings will be 
retained until all analyses are completed, and results have been disseminated via publications and 
reports. This will allow us to verify details from the original data source when creating these 
reports as needed. 
 
11.1 Data Security 
Qualtrics automatically collects IP addresses for survey participants. The survey settings will be 
adjusted to eliminate collection of IP addresses. Qualtrics will generate personal links to surveys. 
Study staff will send the link to each individual participant’s email. Participant emails will not be 
shared with Qualtrics. Data are stored separately from personal identifiers. 
 
We will deliver the program remotely, via videoconference. We will audio record 
program sessions to monitor adherence to the curriculum. We will select the box to audio-record 
sessions. We will save a copy for our research purposes only. 
 
We will follow best practices to maintain security during videoconference meetings. This  
includes locking the room before the meeting, checking names before allowing 
attendees to join, restricting access once all attendees have joined, using a complex password for 
every meeting, confirming attendance with first name roll call, and using password protection for 
audio recordings of the meetings. 
 
11.2 Record Retention 
Personal identifiers will be stored securely by study personnel at OSU, and retained for future 
study recruitment. De-identified data will be stored for use in future related study questions, such 

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as comparing results of this intervention to a future comparison intervention. The PI will be 
responsible for storing all research related materials for a minimum of three years 
post study termination. 
13.0 Statistical Analysis Plan 
Demographics and participant characteristics will be summarized using descriptive statistics. 
Feasibility measures include enrollment in the study, retention in the study, and retention in the 
intervention and will be calculated as total numbers and percentages. Scale scores will be 
evaluated using means and standard deviations. Means and standard deviations at baseline will 
be compared to means and standard deviations at post-intervention follow-up. The focus for this 
study is on the feasibility and acceptability of the intervention, and implementation using 
a videoconference format. With the small sample size, we do not anticipate having sufficient 
power to detect pre-post changes in outcomes. We will calculate changes in scores, but our focus 
will be on estimating effect sizes for a future larger study. 
 
For qualitative analysis, transcripts will be analyzed using structural coding, with codes 
developed directly from the interview guide. At least two members of the team will develop the 
codebook and complete initial coding. Once the team finalizes the codebook, team members will 
independently code each interview. Constant comparison method will ensure coding consistency. 
Codes will be grouped into broader thematic categories that describe patterns in the data related 
to feasibility. The team will meet frequently to discuss results and employ memo taking to 
remain reflexive.