Clinical trial NCT06809933: Exercise and Movement to Enhance Resiliency in Cancer Patients
Official title: EMPOWER: Exercise and Movement to Promote Our Patients With (Gynecologic) Cancer to Enhance Resiliency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancer
Keywords: Physical Activity
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Sword Health, SA
First posted: 2025-02-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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 age group (18-64 year olds, \>=65 year olds).

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

Eligibility criteria: 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 them 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 (e.g., Move wearable or equivalent).
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, they 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.

Primary outcomes:
measure: Recruitment Rate (Stage 1)
timeFrame: Up to 24 months
measure: Recruitment Rate (Stage 2)
timeFrame: Up to 36 months
measure: Enrollment Rate (Stage 1)
timeFrame: Up to 24 months
measure: Enrollment Rate (Stage 2)
timeFrame: Up to 36 months
measure: Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only)
timeFrame: 1 day
measure: Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only)
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Retention Rate
timeFrame: Up to 16 weeks
measure: Percentage of participants who completed prescribed exercises
timeFrame: Up to 16 weeks
measure: Percentage of participants who utilized the mobile application
timeFrame: Up to 16 weeks
measure: Percent attendance of the online meetings
timeFrame: Up to 16 weeks
measure: Mean changes in average step count over time
timeFrame: Up to 16 weeks
measure: Mean changes in the minutes participants were active over time
timeFrame: Up to 28 weeks
measure: Mean changes in scores on the short performance physical battery (SPPB) survey over time
timeFrame: Up to 28 weeks
measure: Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Global Health v1.2
timeFrame: Up to 28 weeks
measure: Mean changes in scores on Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Physical function (PF) 10b
timeFrame: Up to 28 weeks
measure: Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a
timeFrame: Up to 28 weeks
measure: Mean changes in scores on the Generalized Anxiety Disorder Questionnaire (GAD-7) over time
timeFrame: Up to 28 weeks
measure: Mean changes in depression scores on the Patient Health Questionnaire-9 (PHQ-9) over time
timeFrame: Up to 28 weeks
measure: Mean changes in scores on the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG) - Neurotoxicity (FACT/GOG-NTX)
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephanie Cham, MD
role: PRINCIPAL_INVESTIGATOR
References: