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

September 4, 2025 updated by: Zahra A. Barandouzi, Emory University

Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
        • Principal Investigator:
          • Zahra A. Barandouzi, Ph.D.,MSN,RN
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
        • Principal Investigator:
          • Zahra A. Barandouzi, Ph.D.,MSN,RN
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
        • Principal Investigator:
          • Zahra A. Barandouzi, Ph.D.,MSN,RN
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Emory Decatur Hospital
        • Contact:
        • Principal Investigator:
          • Zahra A. Barandouzi, Ph.D.,MSN,RN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: Questionnaire Administration
Ancillary studies
Other: Medical Device Usage and Evaluation
Wear an activity tracker
Other: Exercise Intervention
Participate in an individualized online home-based exercise intervention
Other: Functional Assessment
Complete functional capacity assessment
Other: Supportive Care
Receive social support
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attrition Rates (Feasibility)
Time Frame: 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.
At 12 weeks
Adherence Rates (Feasibility)
Time Frame: 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.
At 12 weeks
Intervention Acceptability
Time Frame: 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.
Up to 12 weeks
Gut Microbiome
Time Frame: 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.
From baseline to 12 weeks
Psychoneurological Symptoms
Time Frame: 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.
From baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid Eating Assessment for Participants
Time Frame: 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.
Up to 12 weeks
Stress
Time Frame: 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.
Up to 12 weeks
Quality of Life Assessment
Time Frame: 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.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Zahra A Barandouzi, Ph.D.,MSN,RN, Emory University Hospital/Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2027

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 4, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007783
  • P30CA138292 (U.S. NIH Grant/Contract)
  • NCI-2024-08387 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • EU6320-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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