Breast Cancer, Gynecologic Cancers
Conditions
Keywords
cancer survivorship, mindfulness, sexual health, intervention
Brief summary
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.
Interventions
BEHAVIORALMindful After Cancer Program
The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.
Sponsors
Oregon State University
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Access to high speed internet via smart phone, tablet, and/or computer
Exclusion criteria
• Those who do not comprehend English since the MAC program is only available in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Accrual Rate- The percent of eligible candidates who enroll | Baseline | — |
| Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist. | Up to 1 week post-intervention. | 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. |
| Retention Rate - The percent of enrolled participants who complete all study surveys | Up to the 3 month post-intervention survey at week 22. | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAC intervention Drop Out- As measured by session attendance. | Up to completion of the 8-week MAC intervention. | Percentage of enrolled participants who stop attending the MAC intervention arm after attending the first session. |
Countries
United States
Contacts
CONTACTJessica Gorman, PhD
Outcome results
None listed