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Gynecologic CancerEMPOWERNCT06809933

Exercise and Movement to Enhance Resiliency in Cancer Patients

A study testing Digital Health Mobile App, Virtual Support Group and Health Coaching in people with Gynecologic Cancer, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Gynecologic Cancer
What is being tested?
Digital Health Mobile App, Virtual Support Group and Health Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
24 Mar 2025to 31 Aug 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nathalie Halley contact

877-827-3222

EMPOWER@ucsf.edu

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Nathalie Halley, EMPOWER@ucsf.edu

    877-827-3222, cancertrials@ucsf.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

Stage 1 (single-arm pilot of intervention)

  1. 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).

  1. 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

  1. 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.

Being tested
Digital Health Mobile App, Virtual Support Group, Health Coaching, FitBit, Handouts
Keywords
Physical Activity
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Health Mobile AppOther

    Also called Digital health technology (DHT), Move 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

  • Virtual Support GroupOther

    Also called Video Support Group

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

  • Health CoachingOther

    Also called Virtual Health Coach, Certified Health Coach

    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

  • FitBitOther

    Also called Activity Tracking Device

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

  • HandoutsOther

    Also called Study Handouts

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

Study groups in NCT06809933
Study groupRoleWhat they receive
Stage 1: EMPOWER Feasibility CohortExperimentalThe first 20 participants enrolled with receive the EMPOWER intervention which consists of the "Move" mobile application that synchronizes with a FitBit that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.
Receives: Other: Digital Health Mobile App; Other: Virtual Support Group; Other: Health Coaching
Stage 2: EMPOWERExperimentalParticipants randomized to the EMPOWER intervention will receive the "Move" mobile application that synchronizes with a FitBit that tracks heart rate, step count, and motion and also receive UCSF-based, online peer support network with individual and small group sessions that occur every four weeks. Questionnaires will be given at baseline, week 9, the end of treatment, and at 3 months after completion of the interventions.
Receives: Other: Digital Health Mobile App; Other: Virtual Support Group; Other: Health Coaching
Stage 2: Enhanced usual care (EUS)Active comparatorParticipants randomized to the EUS group will receive a similar kit that includes a FitBit (equivalent features to what the intervention arm receives), and receive a handout that details recommended national guidelines on exercise during cancer treatment. Participants will be asked to allow the FitBit to be linked to a study email that provides a summary of weekly activity to track activity throughout the study.
Receives: Other: FitBit; Other: Handouts

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment Rate (Stage 1)

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

    Measured: Up to 20 days

  2. Recruitment Rate (Stage 2)

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

    Measured: Up to 20 days

  3. Enrollment Rate (Stage 1)

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

    Measured: Up to 20 days

  4. Enrollment Rate (Stage 2)

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

    Measured: Up to 20 days

  5. 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.

    Measured: 1 day

  6. 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

    Measured: Up to 16 weeks

Secondary outcomes (13)
  1. Retention Rate

    The retention rate of participants in both groups will be reported as a percentage of participants. Retention is defined as >50% of the participants

    Measured: Up to 16 weeks

  2. Percentage of participants who completed prescribed exercises

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

    Measured: Up to 16 weeks

  3. Percentage of participants who utilized the mobile application

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

    Measured: Up to 16 weeks

  4. Percent attendance of the online meetings

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

    Measured: Up to 16 weeks

  5. Mean changes in average step count over time

    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

    Measured: Up to 16 weeks

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

    The mean change in average active time as measured in minutes by the wearable device will be reported along with a 90% confidence interval

    Measured: Up to 16 weeks

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

    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.

    Measured: Up to 16 weeks

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

    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.

    Measured: Up to 7 months

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

    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.

    Measured: Up to 7 months

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

    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.

    Measured: Up to 7 months

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

    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.

    Measured: Up to 7 months

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

    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.

    Measured: Up to 7 months

  13. Mean changes in scores on the Functional Assessment of Cancer Therapy (FACT)/Gynecologic Oncology Group (GOG) - Neurotoxicity (FACT/GOG-NTX)

    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.

    Measured: Up to 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start24 Mar 2025
  3. Primary completion31 Aug 2031 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809933
Sponsor's protocol ID
244013
Other IDs
NCI-2025-00773
Acronym
EMPOWER
Status last verified
Jan 2026
First submitted
30 Jan 2025
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital Health Mobile App, Virtual Support Group and Health Coaching in people with Gynecologic Cancer, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nathalie Halley (877-827-3222, EMPOWER@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment Rate (Stage 1) (time frame: Up to 20 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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