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

Not Applicable

Completed

• Conditions: Breast Cancer; Gynecologic Cancer
• Interventions: Behavioral: Mindful After Cancer

• Registration Number: NCT04559854
• Lead Sponsor: Oregon State University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-23
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-05
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-01
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mindful After Cancer	Mindful After Cancer	Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in facets of baseline mindfulness at 1 month	Baseline and 1 month post-intervention	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.
Change from baseline body image at 1 month	Baseline and 1 month post-intervention	Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.
Change from baseline body appreciation at 1 month	Baseline and 1 month post-intervention	Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.
Change from baseline anxiety at 1 month	Baseline and 1 month post-intervention	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.
Change from baseline depression at 1 month	Baseline and 1 month post-intervention	Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms
Change from satisfaction with sex life at 1 month	Baseline and 1 month post-intervention	New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.
Change from baseline self-efficacy at 1 month	Baseline and 1 month post-intervention	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.
Change from baseline self-compassion at 1 month	Baseline and 1 month post-intervention	Self-Compassion Scale short form. 12 items. Range 12-60. Higher score indicates greater self-compassion.
Change from baseline relationship quality at 1 month	Baseline and 1 month post-intervention	Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality
Change from baseline interest in sexual activity at 1 month	Baseline and 1 month post-intervention	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.

Trial Locations

Locations (1)

Oregon State University; 🇺🇸 Corvallis, Oregon, United States