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NCT Number: NCT06809933

Exercise and Movement to Enhance Resiliency in Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Nathalie Halley

CONTACT

[email protected]

Stephanie Cham, MD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

877-827-3222

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Digital Health Mobile App

Other

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

Other names: Digital health technology (DHT), Move App

Virtual Support Group

Other

An institutional, virtual peer support group session will include a maximum of 5 participant per group

Other names: Video Support Group

Health Coaching

Other

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

Other names: Virtual Health Coach, Certified Health Coach

FitBit

Other

FitBit is a health and activity tracking device placed around the wrist

Other names: Activity Tracking Device

Handouts

Other

A handout with exercise recommendations for those with cancer in accordance with national guidelines

Other names: Study Handouts

Primary outcomes

  1. Recruitment Rate (Stage 1)

    Time frame: Up to 20 days

    Feasibility of the intervention is defined as >= 30% recruitment rate for participants in Stage 1.

  2. Recruitment Rate (Stage 2)

    Time frame: Up to 20 days

    Feasibility of the intervention is defined as >= 30% recruitment rate for participants in Stage 2.

  3. Enrollment Rate (Stage 1)

    Time frame: Up to 20 days

    Feasibility of the intervention is defined as > 30% enrollment rate for participants in Stage 1.

  4. Enrollment Rate (Stage 2)

    Time frame: Up to 20 days

    Feasibility of the intervention is defined as > 30% enrollment rate for participants in Stage 2.

  5. Percentage of participants recommending the EMPOWER intervention (Stage 1 & 2, EMPOWER Participants only)

    Time frame: 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.

  6. Percentage of participants adherence to the intervention (Stage 2, EMPOWER Participants only)

    Time frame: 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 outcomes

  1. Retention Rate

    Time frame: 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

  2. Percentage of participants who completed prescribed exercises

    Time frame: Up to 16 weeks

    The percentage of participants who completed at least 50% of prescribed exercises will be reported

  3. Percentage of participants who utilized the mobile application

    Time frame: Up to 16 weeks

    The percentage of participants who utilized at least 75% of the mobile application will be reported.

  4. Percent attendance of the online meetings

    Time frame: Up to 16 weeks

    The percentage of participants who attended at least 50% of the online peer support sessions will be reported

  5. Mean changes in average step count over time

    Time frame: 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

  6. Mean changes in the minutes participants were active over time

    Time frame: Up to 16 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

  7. Mean changes in scores on the short performance physical battery (SPPB) survey over time

    Time frame: Up to 16 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.

  8. Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Global Health v1.2

    Time frame: Up to 7 months

    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.

  9. Mean changes in scores on Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Physical function (PF) 10b

    Time frame: Up to 7 months

    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.

  10. Mean changes in scores on the Patient Reported Outcomes Measurement Information System-Cancer (PROMIS) Fatigue- Short Form 4a

    Time frame: Up to 7 months

    This 4-item questionnaire to measure fatigue based on responses to statements about how the participants feel with a response ranging from 1="Not at all" to 5="Very Much", and a total raw score ranging from 4 - 20, which are converted to a scaled T-score (range 33.7 to 75.8) with higher scores indicating a greater feeling of fatigue. The mean change in scores along with a 90% confidence interval will be reported.

  11. Mean changes in scores on the Generalized Anxiety Disorder Questionnaire (GAD-7) over time

    Time frame: Up to 7 months

    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.

  12. Mean changes in scores on the Life Space Assessment (LSA)

    Time frame: Up to 7 months

    The LSA is a 5-item questionnaire assessing mobility in adults. Each item on the assessment is associated with 3 factors: Accessing Spaces (0=No, 1=Yes), Frequency (1=Less than 1/week up to 4=Daily), and Independence (1=Personal assistance needed to 2=No equipment or personal assistance needed). Each space level is scored by Accessing Spaces score x Frequency score x Independence score. The total LSA score is calculated by taking the sum of each of the 5 items. Higher scores indicate a higher usage of life space.

  13. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie Halley

CONTACT

[email protected]

877-827-3222

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Sword Health, SA

Registry information

Official study title

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

Acronym: EMPOWER

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Feb 5, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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