Exercise and Movement to Enhance Resiliency in Cancer Patients

a study on Gynecologic Cancer

Summary

Eligibility
for females ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Stephanie Cham, MD
Headshot of Stephanie Cham
Stephanie Cham

Description

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.

Official Title

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

Details

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 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.

Keywords

Gynecologic Cancer, Physical Activity, Digital Health Mobile App, Virtual Support Group, Health Coaching, Wearable Activity Tracker, Handouts

Eligibility

You can join if…

Open to females ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • UCSF accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Stephanie Cham, MD
    Dr. Stephanie Cham’s primary research focus is to reduce disparities and improve perioperative care for gynecologic cancer patients, particularly in vulnerable populations, through innovative healthcare services outcomes research and the development of novel and scalable interventions including those leveraging new care delivery approaches and technology.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06809933
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated
Contact us about this trial