Recruiting

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

Sponsor:

Emory University

Code:

NCT06709534

Conditions

Malignant Female Reproductive System Neoplasm

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Functional Assessment

Medical Device Usage and Evaluation

Questionnaire Administration

Supportive Care

Study Details

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.

Conditions

Malignant Female Reproductive System Neoplasm

Study ID

NCT06709534

Start date

Sep 1, 2025

Status verified date

Sep, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Supportive Care (individualized online home-based exercise)

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 RPE scale and receive social support over 30 minutes BIW for 12 weeks.

Interventions

Exercise Intervention

Participate in an individualized online home-based exercise intervention

Functional Assessment

Complete functional capacity assessment

Medical Device Usage and Evaluation

Wear an activity tracker

Questionnaire Administration

Ancillary studies

Supportive Care

Receive social support

Primary outcome measure

Attrition Rates (Feasibility) [ Time Frame: At 12 weeks ]
Adherence Rates (Feasibility) [ Time Frame: At 12 weeks ]
Intervention Acceptability [ Time Frame: Up to 12 weeks ]
Gut Microbiome [ Time Frame: From baseline to 12 weeks ]
Psychoneurological Symptoms [ Time Frame: From baseline to 12 weeks ]

Central Contacts and Locations

Central contacts

Zahra Barandouzi, Ph.D.,MSN,RN

4045449078 zahra.barandouzi@emory.edu

Locations

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts