RecruitingInterventional

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

NCT ID: NCT06809933Sponsor: University of California, San FranciscoLast updated: 2026-01-26

Summary

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.

Detailed description

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.

Arms & interventions

OtherDigital 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
OtherVirtual Support Group
An institutional, virtual peer support group session will include a maximum of 5 participant per group
OtherHealth 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
OtherFitBit
FitBit is a health and activity tracking device placed around the wrist
OtherHandouts
A handout with exercise recommendations for those with cancer in accordance with national guidelines

Outcome measures

Primary

Recruitment Rate (Stage 1)
Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 1.
Time frame: Up to 20 days
Recruitment Rate (Stage 2)
Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 2.
Time frame: Up to 20 days
Enrollment Rate (Stage 1)
Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 1.
Time frame: Up to 20 days
Enrollment Rate (Stage 2)
Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 2.
Time frame: Up to 20 days
Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only)
Acceptability of the intervention will be measured by a physician designed questionnaire assessing the acceptability of the EMPOWER intervention. The questionnaire is an 8-item measure of which assesses participants perceived acceptability of the EMPOWER program. Each item response falls on a scale of 1 (Strongly disagree) to 5 (Strongly agree). The percentage of participants with a response of either agree or strongly agree will be reported.
Time frame: 1 day
Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only)
Adherence to the intervention will be measured for each participant, from week 1 to study completion per data collected by wearable device and by CHC collection. The percentage of participants will be reported
Time frame: Up to 16 weeks

Secondary

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

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: 1. Age 18 years or older. 2. 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.). 3. Able to understand study procedures and to comply with study procedures for the entire length of the study. 4. Ability to understand a written informed consent document, and the willingness to sign it. 5. Eastern Cooperative Oncology Group (ECOG) status \< 4. 6. Willingness to participate and wear an activity tracker (FitBit). 7. Planning to start systemic treatment or currently receiving Cycle 1 of systemic treatment. Exclusion Criteria: 1. Medically ineligible or contraindications to exercise as determined by their oncologist; or contradiction to any other study-related procedure or assessment. 2. 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. 3. Existing performance of excessive physical activity (\>210 minutes per week of moderate to vigorous intensity exercise at baseline). 4. Existing enrollment in an exercise program or physical therapy program. 5. Inability to speak and read English.

Study locations (1)

University of California, San Francisco

San Francisco, California, 94143

Recruiting

Nathalie Halley · Contact

EMPOWER@ucsf.edu

· Contact

877-827-3222 cancertrials@ucsf.edu

Stephanie Cham, MD · Principal Investigator