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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Gynecologic Cancer
• Intervention / Treatment: Behavioral: Mindful After Cancer

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Corvallis, Oregon, United States, 97331
      • Oregon State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindful After Cancer; 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; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Interest in Sexual Activity at 1 Month	PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.	Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline 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 (T1) and 1 month post-intervention (T2)
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 (T1) and 1 month post-intervention (T2)
Change From Baseline Body Image at 1 Month	Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.	Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Body Appreciation at 1 Month	Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.	Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Anxiety at 1 Month	PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.	Baseline (T1) and 1 month post-intervention (T2)
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 (T1) and 1 month post-intervention (T2)
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 (T1) and 1 month post-intervention (T2)
Change From Baseline Self-compassion at 1 Month	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.	Baseline (T1) and 1 month post-intervention (T2)
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 (T1) and 1 month post-intervention (T2)

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: OHSU Knight Cancer Institute
• Investigators: Principal Investigator: Jessica R Gorman, PhD, MPH, Oregon State University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 5, 2020

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-2019-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No