Exercise and Movement to Enhance Resiliency in Cancer Patients

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer

• Registration Number: NCT06809933
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2025-01-30
• Study First Submitted QC: 2025-01-30
• Status Verified: 2025-03
• Study Start: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27
• Primary Completion: 2031-08-31
• Study Completion: 2031-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Recruitment Rate (Stage 1)	Up to 24 months	Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 1.
Recruitment Rate (Stage 2)	Up to 36 months	Feasibility of the intervention is defined as \>= 30% recruitment rate for participants in Stage 2.
Enrollment Rate (Stage 1)	Up to 24 months	Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 1.
Enrollment Rate (Stage 2)	Up to 36 months	Feasibility of the intervention is defined as \> 30% enrollment rate for participants in Stage 2.
Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only)	1 day	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.
Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only)	Up to 16 weeks	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

Secondary Outcome Measures

Name	Time	Method
Retention Rate	Up to 16 weeks	The retention rate of participants in both groups will be reported as a percentage of participants. Retention is defined as \>50% of the participants
Percentage of participants who completed prescribed exercises	Up to 16 weeks	The percentage of participants who completed at least 50% of prescribed exercises will be reported
Percentage of participants who utilized the mobile application	Up to 16 weeks	The percentage of participants who utilized at least 75% of the mobile application will be reported.
Percent attendance of the online meetings	Up to 16 weeks	The percentage of participants who attended at least 50% of the online peer support sessions will be reported
Mean changes in average step count over time	Up to 16 weeks	The mean change in average step count as measured by the wearable device (Move wearable or equivalent) and actigraphy for participants as tracked by a wearable device will be reported along with a 90% confidence interval
Mean changes in the minutes participants were active over time	Up to 28 weeks	The mean change in average active time as measured in minutes by the wearable device will be reported along with a 90% confidence interval
Mean changes in scores on the short performance physical battery (SPPB) survey over time	Up to 28 weeks	The SPPB is an objective measurement instrument developed by the National Institute of Aging (NIA) to measure balance, lower extremity strength, and functional capacity in older adults (\>65 years of age). The test includes three different domains (walking, sit-to-stand and balance activities and are assessed and assigned points by a physician or study staff to assess overall functional mobility. Each task is assigned a number of points or a confirmation of completion, with higher points or task completion indicating better balance, better extremity strength, and higher functional capacity. will be performed via video visit. Each component is scored from 0-4 with a total of 12 with higher scores predictive of immobility, reduced activities of daily living (ADLs), and falls.
Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Global Health v1.2	Up to 28 weeks	The Patient Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health (also referred to as PROMIS-10) is a ten-item patient reported measure of physical, mental and social health. Items query general health, quality of life, physical health, mental health, satisfaction with discretionary social activities, carrying out every day physical activities, pain, fatigue, satisfaction with social roles, and emotional problems. with a response ranging from 1="Poor" to 5="Excellent" with 1 item addressing pain with a raw score range of 0 "No pain at all" to 10="Worst possible pain". The total raw score ranging from 4 - 50, which are converted to a scaled T-score (range of 16.2 - 67.7) with higher scores indicating a greater overall quality of life. Mean changes in the global score will be reported along with a 90% confidence interval.
Mean changes in scores on Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Physical function (PF) 10b	Up to 28 weeks	The PROMIS PF 10b is a 10-item questionnaire which measures respondents' self-reported capability to physically function in the context of cancer and/or cancer treatment experiences with a response ranging from 1="Not at all" to 5="Cannot do", and a total raw score ranging from 10 - 50, which are converted to a scaled T-score (range of 13.8 - 61.3) with higher scores indicating a greater hinderance to engagement in physical activities. The mean change in scores along with a 90% confidence interval will be reported.
Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Pain Interference- Short Form 4a	Up to 28 weeks	This 4-item questionnaire to measure the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities based on responses to statements about how the participants feel with a response ranging from 1="Never" to 5="Always", and a total raw score ranging from 4 - 20, which are converted to a scaled T-score (range 41.6 to 75.6) with higher scores indicating a greater hinderance to engagement in activities based on how much pain participants are experiencing. The mean change in scores along with a 90% confidence interval will be reported.
Mean changes in scores on the Generalized Anxiety Disorder Questionnaire (GAD-7) over time	Up to 28 weeks	The GAD-7 is a seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. Scores of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. The mean change in scores along with a 90% confidence interval will be reported.
Mean changes in depression scores on the Patient Health Questionnaire-9 (PHQ-9) over time	Up to 28 weeks	The Patient Health Questionnaire-9 (PHQ-9) is used to measure depression symptoms. The total Patient Health Questionnaire-9 (PHQ-9) score is calculated by combining the responses of the participant on questions addressing how bothered the participant has been by various problems over the past 2 weeks. Each of the 9 items is scored on a scale of 0 ("Not bothered at all") to 4 ("Nearly every day"). A total score of 5-9='Mild Depression Symptoms", 10-14="Minor Depression, Major Depression (mild), or Dysthymia", 15-19="Major Depression, moderately severe", and \>20="Major Depression". The mean change in scores along with a 90% confidence interval will be reported
Mean changes in scores on the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG) - Neurotoxicity (FACT/GOG-NTX)	Up to 28 weeks	The FACT/GOG-NTX is a 38-item questionnaire to assess symptoms quality of life and peripheral neuropathy in cancer patients undergoing chemotherapy. The FACT/GOG-NTX item responses range from 0 (not at all) to 4 (very much). To calculate the FACT/GOG-Ntx Trial Outcome Index (TOI) score, the sum of the item scores from the physical well-being subscale, the functional well-being subscale and the neurotoxicity subscale are combined to create a TOI score ranging from 0-100 with higher scores indicating a better QOL.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States