Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer

Study Overview
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Brief Summary
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The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.

Detailed Description
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The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.

Official Title
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Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being

Conditions
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Breast Cancer, Gynecologic Cancer

Intervention / Treatment
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* Behavioral: Mindful After Cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of breast or gynecologic cancer at least one year prior to enrollment English speaking Have access to a computer, smart phone, or tablet with internet access Ability to spend 15-30 minutes per day on program activities Exclusion Criteria: - Stage 0 (carcinoma in situ)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful After Cancer<br>Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. | Behavioral: Mindful After Cancer<br>* The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility/ Enrollment | Number of participants enrolled, Proportion of participants enrolled of those eligible | Baseline | 
| Feasibility/ Retention in Study | Number and proportion of participants completing all assessments | 1 month post-intervention | 
| Feasibility/ Retention in the Program | Mean number of sessions attended, Proportion of participants attending at least 6 of 8 sessions | 1 month post-intervention | 
| Acceptability | Endorsement of 10 items characterizing acceptability (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability. | 1 month post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline self-efficacy at 1 month | Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer. | Baseline and 1 month post-intervention | 
| Change from baseline body image at 1 month | Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image. | Baseline and 1 month post-intervention | 
| Change from baseline body appreciation at 1 month | Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation. | Baseline and 1 month post-intervention | 
| Change from baseline anxiety at 1 month | PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Raw scores are translated to a T score following PROMIS guidelines. Higher score indicates greater anxiety symptoms. | Baseline and 1 month post-intervention | 
| Change from baseline depression at 1 month | Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms | Baseline and 1 month post-intervention | 
| Change in facets of baseline mindfulness at 1 month | Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness. | Baseline and 1 month post-intervention | 
| Change from baseline self-compassion at 1 month | Self-Compassion Scale short form. 12 items. Range 12-60. Higher score indicates greater self-compassion. | Baseline and 1 month post-intervention | 
| Change from baseline relationship quality at 1 month | Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality | Baseline and 1 month post-intervention | 
| Change from baseline interest in sexual activity at 1 month | PROMIS SexFS 2.0. 2 items. Range 2-10. Raw scores are translated to a T score following PROMIS guidelines. Higher score indicates more interest in sexual activity. | Baseline and 1 month post-intervention | 
| Change from satisfaction with sex life at 1 month | New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction. | Baseline and 1 month post-intervention |