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

Breast Cancer Clinical Trial

— MAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559854
• Other study ID #: 20181004
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: October 5, 2020

Study information

• Verified date: December 2020
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 5, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Gynecologic Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon State University	OHSU Knight Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility/ Enrollment	Number of participants enrolled, Proportion of participants enrolled of those eligible	Baseline
Primary	Feasibility/ Retention in Study	Number and proportion of participants completing all assessments	1 month post-intervention
Primary	Feasibility/ Retention in the Program	Mean number of sessions attended, Proportion of participants attending at least 6 of 8 sessions	1 month post-intervention
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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