Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 10:33 AM
Study NCT ID:
NCT06709534
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Individualized Online Home-Based Exercise Program for Improving Symptoms in Gynecologic Cancer Survivors
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
Status:
RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
This clinical trial tests an individualized online home-based exercise program in gynecologic cancer survivors and its impact on gut microbiome (the bacteria and microorganisms that live in the digestive system) and symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment. These symptoms can significantly reduce the quality of life (QoL) and survival rate in this cancer population. Thus, promoting physical activity among cancer survivors may help mitigate these severe symptoms. Using online platforms such as Zoom can help participants access an individualized exercise program that meets their specific needs to engage in physical activity and decrease their symptom burden. Home-based exercise, by providing self-chosen time and location and low costs, can address some barriers to physical activity for cancer survivors. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in gynecologic cancer survivors.
Detailed Description:
PRIMARY OBJECTIVES:
I. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors.
II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors.
OUTLINE:
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.
I. To examine the feasibility and acceptability of an individualized home-based exercise program in gynecologic cancer survivors.
II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors.
OUTLINE:
Participants meet with a certified exercise trainer and complete a functional capacity assessment using a treadmill or 6-minute walk test. Participants then complete an individualized online home-based exercise intervention via Zoom consisting of progressive, moderate-intensity walking corresponding to the rate of perceived exertion (RPE) scale and receive social support over 30 minutes twice a week (BIW) for 12 weeks.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA138292 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2024-08387 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| EU6320-24 | OTHER | Emory University Hospital/Winship Cancer Institute | View |