Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors

Официальное название

Virtual Mindful After Cancer Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors

Обзор

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.

Вмешательства

• Поведенческое Mindful 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.

Первичные конечные точки

• Recruitment Accrual Rate- The percent of eligible candidates who enroll [Срок оценки: Baseline]
• Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist. [Срок оценки: Up to 1 week post-intervention.]
• Retention Rate - The percent of enrolled participants who complete all study surveys [Срок оценки: Up to the 3 month post-intervention survey at week 22.]

Вторичные конечные точки (1)

• MAC intervention Drop Out- As measured by session attendance. [Срок оценки: Up to completion of the 8-week MAC intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Those who do not comprehend English since the MAC program is only available in English.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Samaritan Pastega Regional Cancer Center — Corvallis
• University of Pennsylvania — Philadelphia
• Fox Chase Cancer Center — Philadelphia

Идентификаторы

NCT: NCT07055854 · HE-2023-492 · 1R34CA286710

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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