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): 28
• 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
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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	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

Collaborators and Investigators

• Sponsor: Oregon State University
• Collaborators: OHSU Knight Cancer Institute

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 (ACTUAL): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 1, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20181004

Drug and device information, study documents

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