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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
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.
Oregon State University
Corvallis, Oregon, United States
Feasibility/ Enrollment in the Study
Percentage of participants enrolled of those eligible
Time frame: Baseline (T1)
Feasibility/ Retention in the Study
Number and percentage of participants completing all assessments
Time frame: 1 month post-intervention (T2)
Feasibility/ Retention in the Intervention
Number and percentage attending at least 6 of 8 sessions
Time frame: 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.
Time frame: 1 month post-intervention (T2)
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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline (T1) and 1 month post-intervention (T2)