An Individualized Online Home-Based Exercise Program for Improving Symptoms in Disadvantaged Gynecologic Cancer Survivors

Not Applicable

Not yet recruiting

• Conditions: Malignant Female Reproductive System Neoplasm

• Registration Number: NCT06709534
• Lead Sponsor: Emory University

Brief Summary

This clinical trial tests an individualized online home-based exercise program in disadvantaged 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 with low SES 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 with low SES. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in disadvantaged 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 with low SES.

II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors with low SES.

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 Timeline

• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-11-25
• Study First Posted: 2024-11-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Study Start: 2025-07-01
• Primary Completion: 2026-07-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Women aged ≥ 18 years old
• Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
• Enrolled in Medicaid (as a factor to determine a low SES)
• 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
• Had surgery (including gynecologic surgery) within the past six weeks
• Are currently participating in a regular physical activity program (regular ≥ 3 times/week moderate-intensity exercise)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Attrition rates (Feasibility)	At 12 weeks	Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if \>80% of participants remain enrolled and complete the study, respectively.
Adherence rates (Feasibility)	At 12 weeks	Feasibility will be assessed by calculating attrition and adherence rates, identifying reasons for refusal, and evaluating the completeness of the data. We will consider the intervention to have low attrition and high adherence if \> 80% of participants remain enrolled and complete the study, respectively.
Intervention acceptability	Up to 12 weeks	Will be evaluated with a survey to assess participants' perceptions of the acceptability of the study procedures. A response rate of \> 80% will be considered high acceptability. Descriptive statistics will be calculated using SPSS and R software.
Gut microbiome	From baseline to 12 weeks	Gut microbiota composition will be evaluated using collected stool samples. The preliminary efficacy of the intervention on gut microbiome and psychoneurological symptoms (PNS) will be compared using a paired t-test.
Psychoneurological symptoms	From baseline to 12 weeks	Will be assessed using the Fatigue Short Form, Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Depression and Anxiety Short Form, Pain Interference Short Form, PROMIS Cognitive Function Short Form, PROMIS Sleep Disturbance Short Form, the PROMIS gastrointestinal (GI) constipation and diarrhea Short Forms. The preliminary efficacy of the intervention on gut microbiome and PNS will be compared using a paired t-test.

Secondary Outcome Measures

Name	Time	Method
Stress	Up to 12 weeks	Stress level will be measured using PSS. The preliminary efficacy of the intervention on stress will be compared using a paired t-test.
Quality of life	Up to 12 weeks	Quality of life will be assessed using the Short Form-8 questionnaire. The preliminary efficacy of the intervention on quality life will be compared using a paired t-test.
Rapid Eating Assessment for Participants	Up to 12 weeks	Rapid Eating Assessment for Participants will be used to evaluate their diet. Diet will be assessed to control this variable for measuring gut microbiome.

Trial Locations

Locations (4)

Grady Health System; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

Emory Decatur Hospital; 🇺🇸 Decatur, Georgia, United States