Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOregon State University
About this trial
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns.
The main study aims are to:
1. Develop effective plans for recruiting participants across multiple sites 2. Evaluate participation in the program and surveys 3. Develop plans to train and supervise the professionals who will deliver the program.
Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial.
Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program.
Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey.
All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years old
Diagnosed with female breast or gynecologic cancer at stage I-IV
Diagnosed at least 6 months ago
At least one sexual concern in a validated screener
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Mindful After Cancer Program
BehavioralThe Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Accrual Rate- The percent of eligible candidates who enroll
Time frame
Baseline2
Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist.
Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session.
Time frame
Up to 1 week post-intervention.3
Retention Rate - The percent of enrolled participants who complete all study surveys
Time frame
Up to the 3 month post-intervention survey at week 22.Secondary outcomes
1
MAC intervention Drop Out- As measured by session attendance.
Percentage of enrolled participants who stop attending the MAC intervention arm after attending the first session.
Time frame
Up to completion of the 8-week MAC intervention.Other outcomes
1
Exploratory outcome: Interest in sexual activity as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction Scale.
To compare sexual interest longitudinally after enrollment between those receiving MAC and those receiving usual care. The sexual interest domain has 2 items, Range 2-10. Higher score indicates more interest in sexual activity.
Time frame
Up to the 3 month post-intervention survey at week 22.2
Exploratory Outcome: Body Appreciation as measured by the Body Appreciation Scale.
To compare body appreciation longitudinally after enrollment between those receiving MAC and those receiving usual care. The Body Appreciation Scale has13 items, Range 13-65. Higher score indicates more positive body appreciation.
Time frame
Up to the 3 month post-intervention survey at week 22.3
Exploratory Outcome: Sexual Satisfaction as measured by the Global Measure of Sexual Satisfaction scale (GMSEX).
To compare sexual satisfaction longitudinally after enrollment between those receiving MAC and those receiving usual care. The GMSEX scale has 5 items, Range 5-35. Higher score indicates higher level of sexual satisfaction.
Time frame
Up to the 3 month post-intervention survey at week 22.4
Exploratory outcome: Self-Efficacy as measured by the Self-Efficacy for Managing Chronic Disease Scale (adapted).
To compare self-efficacy for managing sexual health in chronic disease longitudinally after enrollment between those receiving MAC and those receiving usual care. The adapted self-efficacy for managing chronic disease scale has 6 items, Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.
Time frame
Up to the 3 month post-intervention survey at week 22.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon State University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov