Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer (MAC)
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|ClinicalTrials.gov Identifier: NCT04559854|
Recruitment Status : Completed
First Posted : September 23, 2020
Last Update Posted : December 3, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Gynecologic Cancer||Behavioral: Mindful After Cancer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being|
|Actual Study Start Date :||July 1, 2019|
|Actual Primary Completion Date :||October 1, 2020|
|Actual Study Completion Date :||October 5, 2020|
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.
- Feasibility/ Enrollment [ Time Frame: Baseline ]Number of participants enrolled, Proportion of participants enrolled of those eligible
- Feasibility/ Retention in Study [ Time Frame: 1 month post-intervention ]Number and proportion of participants completing all assessments
- Feasibility/ Retention in the Program [ Time Frame: 1 month post-intervention ]Mean number of sessions attended, Proportion of participants attending at least 6 of 8 sessions
- Acceptability [ Time Frame: 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.
- Change from baseline self-efficacy at 1 month [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 89 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Gender Based Eligibility:||Yes|
|Gender Eligibility Description:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- Stage 0 (carcinoma in situ)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04559854
|United States, Oregon|
|Oregon State University|
|Corvallis, Oregon, United States, 97331|
|Principal Investigator:||Jessica R Gorman, PhD, MPH||Oregon State University|
|Responsible Party:||Oregon State University|
|Other Study ID Numbers:||
|First Posted:||September 23, 2020 Key Record Dates|
|Last Update Posted:||December 3, 2020|
|Last Verified:||December 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|