Exercise and Movement to Enhance Resiliency in Cancer Patients

Официальное название

EMPOWER: Exercise and Movement to Promote Our Patients With (Gynecologic) Cancer to Enhance Resiliency

Обзор

This is a single-center, pilot, hybrid type 1 design implementation study to evaluate the feasibility and implementation of a personalized digital exercise program and a virtual support group to improve patient-centered outcomes in patients receiving treatment for gynecologic cancer receiving treatment at University of California, San Francisco.

Подробное описание

PRIMARY OBJECTIVES:

Stage 1 (single-arm pilot of intervention)

I. To assess the feasibility of recruitment of the EMPOWER intervention.

II. To assess the acceptability of the Exercise and Movement to Enhance Resiliency in Cancer Patients (EMPOWER) intervention.

Stage 2 (pilot randomized study comparing EMPOWER to enhanced usual care (EUS).

I. To assess the feasibility of recruitment of the study when randomized.

II. To assess the acceptability of a randomized study (in both groups)

SECONDARY OBJECTIVES:

Stage 1 and 2

I. To evaluate retention and adherence of the interventions.

II. To evaluate the components of acceptability and adherence of the interventions.

III. To evaluate changes in objective physical activity measures as a single arm pilot study (stage 1) and compared to EUS (stage 2) of the EMPOWER intervention.

IV. To evaluate changes in improving patient reported quality of life measures as a single arm pilot study (stage 1) and compared to EUS (stage 2) of the EMPOWER intervention.

OUTLINE:

Participants will be enrolled in 2 stages.

Stage 1 is a single-arm pilot study testing the EMPOWER intervention to gather feedback for refinement and optimization of the program to implement in Stage 2.

Stage 2 is a pilot, randomized trial where participants will be assigned in a 1 to 1 ratio to either the EMPOWER program or EUS. All participants will be stratified by treatment type (neoadjuvant versus adjuvant therapy).

Participants will be enrolled in these interventions for a total of 16 weeks and receive a 3-month follow-up.

Вмешательства

• Другое Digital Health Mobile App
  A digital health technology (DHT) called "Move" by Sword Health, which utilizes a mobile app displaying tailored and recommended exercise options, wearable technology (Move wearable or equivalent), and a web-based platform monitored by a physical therapist who will provide individual support
• Другое Virtual Support Group
  An institutional, virtual peer support group session will include a maximum of 5 participant per group
• Другое Health Coaching
  The facilitated group and discussions sessions will be led by a University of California, San Francisco (UCSF) certified health coach (CHC), following a pre-specified agenda and provided virtually
• Другое FitBit
  FitBit is a health and activity tracking device placed around the wrist
• Другое Handouts
  A handout with exercise recommendations for those with cancer in accordance with national guidelines

Первичные конечные точки

• Recruitment Rate (Stage 1) [Срок оценки: Up to 20 days]
• Recruitment Rate (Stage 2) [Срок оценки: Up to 20 days]
• Enrollment Rate (Stage 1) [Срок оценки: Up to 20 days]
• Enrollment Rate (Stage 2) [Срок оценки: Up to 20 days]
• Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only) [Срок оценки: 1 day]
• Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only) [Срок оценки: Up to 16 weeks]

Вторичные конечные точки (12)

• Retention Rate [Срок оценки: Up to 16 weeks]
• Percentage of participants who completed prescribed exercises [Срок оценки: Up to 16 weeks]
• Percentage of participants who utilized the mobile application [Срок оценки: Up to 16 weeks]
• Percent attendance of the online meetings [Срок оценки: Up to 16 weeks]
• Mean changes in average step count over time [Срок оценки: Up to 16 weeks]
• Mean changes in the minutes participants were active over time [Срок оценки: Up to 16 weeks]
• Mean changes in scores on the short performance physical battery (SPPB) survey over time [Срок оценки: Up to 16 weeks]
• Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Global Health v1.2 [Срок оценки: Up to 7 months]
• Mean changes in scores on Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Physical function (PF) 10b [Срок оценки: Up to 7 months]
• Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Fatigue- Short Form 4a [Срок оценки: Up to 7 months]
• Mean changes in scores on the Generalized Anxiety Disorder Questionnaire (GAD-7) over time [Срок оценки: Up to 7 months]
• Mean changes in scores on the Life Space Assessment (LSA) [Срок оценки: Up to 7 months]

Критерии участия

Критерии включения

• Age 18 years or older.
• Newly diagnosed with a gynecological cancer (including ovarian tubal or peritoneal, uterine, cervical, vaginal, vulvar, and/or gestational trophoblastic neoplasia) and currently undergoing treatment chemotherapy, surgery, etc.).
• Able to understand study procedures and to comply with study procedures for the entire length of the study.
• Ability to understand a written informed consent document, and the willingness to sign it.
• Eastern Cooperative Oncology Group (ECOG) status < 4.
• Willingness to participate and wear an activity tracker (FitBit).
• Planning to start systemic treatment or currently receiving Cycle 1 of systemic treatment.

Критерии исключения

• Medically ineligible or contraindications to exercise as determined by their oncologist; or contradiction to any other study-related procedure or assessment.
• Cognitive or visual impairments that would limit participant's ability to utilize and interact with the DHT platform. Note: If a visually impaired participant has a caregiver who can help them use the DHT platform, the participant will not be excluded.
• Existing performance of excessive physical activity (>210 minutes per week of moderate to vigorous intensity exercise at baseline).
• Existing enrollment in an exercise program or physical therapy program.
• Inability to speak and read English.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06809933 · 244013 · NCI-2025-00773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗