Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-29 @ 1:29 PM
Study NCT ID:
NCT06809933
Status:
RECRUITING
Last Update Posted:
2025-11-03
First Post:
2025-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise and Movement to Enhance Resiliency in Cancer Patients
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
EMPOWER: Exercise and Movement to Promote Our Patients With (Gynecologic) Cancer to Enhance Resiliency
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-00773 | REGISTRY | NCI Clinical Trials Reporting Program (CTRP) | View |