Trial Outcomes & Findings for Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors (NCT NCT06331403)

Last Updated: 2025-11-24

Results Overview

The primary feasibility metric will be program engagement, quantified as participant rates of intervention attendance (% attending at least 4 of 6 sessions). Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish feasibility but will rather use these data to inform ongoing protocol refinement.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	Mind-Body Sexual Well-Being Group Intervention Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma. Mind-Body Group Intervention: Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Pilot Trial of a Mind-Body Sexual Well-Being Intervention for Female GI Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mind-Body Sexual Well-Being Group Intervention n=6 Participants Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma. Mind-Body Group Intervention: Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.
Age, Continuous	55 years n=45 Participants
Sex/Gender, Customized Female gender	6 participants n=45 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=45 Participants
Race (NIH/OMB) Asian	0 Participants n=45 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=45 Participants
Race (NIH/OMB) Black or African American	0 Participants n=45 Participants
Race (NIH/OMB) White	6 Participants n=45 Participants
Race (NIH/OMB) More than one race	0 Participants n=45 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants
Region of Enrollment United States	6 participants n=45 Participants

PRIMARY outcome

Timeframe: Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins

Outcome measures

Outcome measures
Measure	Mind-Body Sexual Well-Being Group Intervention n=6 Participants Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma. Mind-Body Group Intervention: Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.
Feasibility of Intervention	6 Participants

PRIMARY outcome

Timeframe: Approximately 6 weeks following group program start

The primary intervention acceptability metric will be participant ratings of overall comfort with the group program (% rating comfort with the group sessions =\>4 on a single 1-5 Likert scale). Given the preliminary, open pilot nature of this protocol, the investigators will not set a priori criteria to establish acceptability but will rather use these data to inform ongoing protocol refinement.

Outcome measures

Outcome measures
Measure	Mind-Body Sexual Well-Being Group Intervention n=6 Participants Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma. Mind-Body Group Intervention: Weekly virtual group meetings with the study interventionist(s) and up to 9 other female cancer survivors over an approximately 6 week period. The group program includes topics related to coping with physical health changes, managing social factors relevant to sexual well-being, and managing thoughts and feelings related to sexual well-being changes.
Acceptability of Intervention	5 Participants

Adverse Events

Mind-Body Sexual Well-Being Group Intervention

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mind-Body Sexual Well-Being Group Intervention n=6 participants at risk Participants in the mind-body sexual well-being group intervention arm will participate in 6 weekly group sessions, delivered via videoconferencing, following enrollment. Group sessions will include content related to mind-body medicine (e.g., relaxation, mindfulness, self-compassion) applied to sexual well-being as well as educational information related to women's sexual well-being in cancer survivorship. Before and after completing the group program, participants will also complete brief self-assessment questionnaires to measure topics including satisfaction with sexuality, coping, loneliness, concern about body image, and stigma.
Gastrointestinal disorders Short-term abdominal discomfort	33.3% 2/6 • Between baseline and end of program (approximately 6 weeks)

Additional Information

Lucy Finkelstein-Fox, PhD

Massachusetts General Hospital

Phone: 617-726-6300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place