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

Not Applicable

Completed

• Conditions: Breast Cancer; Gynecologic 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
• Results First Submitted: 2024-02-08
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Results First Posted: 2025-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
• Completed primary cancer treatment
• 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

Primary Outcome Measures

Name	Time	Method
Feasibility/ Enrollment in the Study	Baseline (T1)	Percentage of participants enrolled of those eligible
Feasibility/ Retention in the Study	1 month post-intervention (T2)	Number and percentage of participants completing all assessments
Feasibility/ Retention in the Intervention	1 month post-intervention (T2)	Number and percentage attending at least 6 of 8 sessions
Acceptability of the Intervention	1 month post-intervention (T2)	Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline Interest in Sexual Activity at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.
Change From Baseline Satisfaction With Sex Life at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	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 (T1) and 1 month post-intervention (T2)	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 Body Image at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.
Change From Baseline Body Appreciation at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.
Change From Baseline Anxiety at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.
Change From Baseline Depression at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms
Change in Facets of Baseline Mindfulness at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	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 Self-compassion at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion.
Change From Baseline Relationship Quality at 1 Month	Baseline (T1) and 1 month post-intervention (T2)	Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality

Trial Locations

Locations (1)

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