Anal Cancer, Colorectal Cancer, Sexual Dysfunction
Conditions
Keywords
sexual well-being, women's health, colorectal cancer, anal cancer
Brief summary
The primary goal of this protocol is to conduct an open pilot to collect initial quantitative and qualitative feedback on the intervention that the investigators are developing. To do so, the investigators will deliver a newly-developed intervention to up to 2 consecutive groups of female colorectal and anal cancer survivors (n = up to 10 per group, total N = up to 20). Participants will provide feedback regarding intervention acceptability, feasibility, and perceived benefit. To inform plans for ongoing program refinement, the investigators will elicit specific feedback about study assessment tools, recruitment procedures, and group factors. Given the early-stage, open pilot nature of this protocol, the investigators will not set strict criteria to establish feasibility and acceptability but will rather interpret each of these outcomes holistically. Qualitative feedback collected in post-intervention exit interviews will also support understanding of feasibility and acceptability. As a secondary aim, the investigators will explore the preliminary effects of the intervention on psychosocial measures of satisfaction with sexuality and impact of functional limitations, coping abilities, acceptance of body image changes, loneliness, and anticipated stigma. As noted above, the investigators will not set specific criteria to establish preliminary efficacy, nor will they consider statistical significance as an indicator of the study's efficacy for these outcomes. Instead, the investigators will consider pre-post intervention effect sizes to consider the need for refinement of study procedures/measurement in a future larger trial. In future, larger-scale, work, the investigators intend to conduct a larger randomized pilot trial to assess intervention acceptability, feasibility, as well as preliminary efficacy on essential outcomes related to sexual well-being.
Detailed description
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 the investigators are developing to enhance sexual well-being among post-treatment female colorectal and anal cancer survivors. The investigators will enroll up to 10 women per group into up to 2 groups (total N = up to 20). The team will run groups consecutively so that any necessary changes from the first open pilot group may be incorporated and re-examined in the second. Participants will complete informed consent prior to initiation of study procedures. To inform ongoing intervention refinement, the investigators will ask participants to complete approximately 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. Participants will also be invited to complete a brief qualitative exit interview with a member of the 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.
Interventions
BEHAVIORALMind-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.
Sponsors
Harvard Medical School (HMS and HSDM)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female sex * English-speaking * Aged 18 or older * Receive any cancer care at MGH-CC sites (Boston, Waltham, Danvers, Newton Wellesley Hospital) * 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.
Exclusion criteria
* 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 * Adults unable to complete study procedures in English. * Participated in an earlier phase of the research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention | Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins | 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. |
| Acceptability of Intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Mind-Body Sexual Well-Being Group Intervention |
|---|---|
| Age, Continuous | 55 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Region of Enrollment United States | 6 participants |
| Sex/Gender, Customized Female gender | 6 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 2 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Acceptability of Intervention
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.
Time frame: Approximately 6 weeks following group program start
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mind-Body Sexual Well-Being Group Intervention | Acceptability of Intervention | 5 Participants |
Primary
Feasibility of Intervention
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.
Time frame: Approximately 6 weeks after the final 6-week (up to N=2 groups) group program begins
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mind-Body Sexual Well-Being Group Intervention | Feasibility of Intervention | 6 Participants |