Personalized online home walking program for women after gynecologic cancer
Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
NA · Emory University · NCT06709534
This trial will test whether a personalized online home walking program can help gynecologic cancer survivors reduce pain, fatigue, sleep problems, depression, cognitive difficulties, and alter gut bacteria.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Emory University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Atlanta, Georgia and 3 other locations) |
| Trial ID | NCT06709534 on ClinicalTrials.gov |
What this trial studies
The program enrolls women who have completed treatment for gynecologic cancers and begins with an in-person functional capacity assessment using a treadmill or a 6-minute walk test with a certified exercise trainer. Participants then follow an individualized progressive, moderate-intensity walking program delivered via Zoom for 30 minutes twice weekly over 12 weeks, with scheduled social-support components. The intervention uses the rate of perceived exertion (RPE) to set intensity and adapts to each participant's abilities and needs. Primary outcomes include feasibility and acceptability of the online home-based program and effects on the gut microbiome and psychoneurological symptoms such as pain, fatigue, sleep disturbance, depression, and cognitive impairment.
Who should consider this trial
Good fit: Women aged 18 or older who previously had gynecologic cancer, have finished chemotherapy or chemoradiation, speak and read English, and do not currently meet recommended exercise levels are ideal candidates.
Not a fit: People with metastatic or other primary cancers, serious uncontrolled psychiatric or medical conditions that limit mobility, or those already meeting exercise guidelines are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could reduce symptom burden and improve quality of life for gynecologic cancer survivors.
How similar studies have performed: Exercise interventions have improved fatigue and quality of life in other cancer survivor groups, but combining individualized online home exercise with gut microbiome outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged ≥ 18 years old * Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical) * Completed cancer treatment (chemotherapy or chemoradiation) * Able to read and speak English * Do not meet recommended exercise levels as defined by The American College of Sports Medicine Exclusion Criteria: * History of metastatic or other primary cancer * Serious mental health conditions (e.g., bipolar disorder, schizophrenia, major depression) * Certain chronic diseases (e.g., muscular-skeletal diseases that limit mobility, autoimmune diseases, uncontrolled diabetes, hypertension, renal disease (creatinine \> 2.5 mg/dL) * Unable to read/speak English
Where this trial is running
Atlanta, Georgia and 3 other locations
- Grady Health System — Atlanta, Georgia, United States (RECRUITING)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (RECRUITING)
- Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States (RECRUITING)
- Emory Decatur Hospital — Decatur, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Zahra A Barandouzi, Ph.D.,MSN,RN — Emory University Hospital/Winship Cancer Institute
- Study coordinator: Zahra Barandouzi, Ph.D.,MSN,RN
- Email: zahra.barandouzi@emory.edu
- Phone: 4045449078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Female Reproductive System Neoplasm