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NCT Number: NCT06709534

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

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.

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Key information

Conditions

Malignant Female Reproductive System Neoplasm

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emory University Hospital Midtown, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

Participate in an individualized online home-based exercise intervention

functional assessment

Other

Complete functional capacity assessment

Medical Device Usage and Evaluation

Other

Wear an activity tracker

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Other

Receive social support

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zahra Barandouzi, Ph.D.,MSN,RN

CONTACT

[email protected]

4045449078

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 29, 2024
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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