MAC: Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Feasibility/ Enrollment [Baseline]
Number of participants enrolled, Proportion of participants enrolled of those eligible
- 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
- 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.
Secondary Outcome Measures
- 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 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 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 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.
- 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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Oregon State University | Corvallis | Oregon | United States | 97331 |
Sponsors and Collaborators
- Oregon State University
- OHSU Knight Cancer Institute
Investigators
- Principal Investigator: Jessica R Gorman, PhD, MPH, Oregon State University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20181004