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

NCT ID: NCT06709534

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2027-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Female Reproductive System Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type OTHER

Participate in an individualized online home-based exercise intervention

Functional Assessment

Intervention Type OTHER

Complete functional capacity assessment

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear an activity tracker

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Supportive Care

Intervention Type OTHER

Receive social support

Interventions

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Exercise Intervention

Participate in an individualized online home-based exercise intervention

Intervention Type OTHER

Functional Assessment

Complete functional capacity assessment

Intervention Type OTHER

Medical Device Usage and Evaluation

Wear an activity tracker

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Supportive Care

Receive social support

Intervention Type OTHER

Other Intervention Names

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Supportive Therapy Symptom Management Therapy, Supportive

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Zahra A. Barandouzi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zahra A Barandouzi, Ph.D.,MSN,RN

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

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Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, United States

Site Status RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Site Status RECRUITING

Emory Decatur Hospital

Decatur, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Zahra Barandouzi, Ph.D.,MSN,RN

Role: CONTACT

4045449078

Facility Contacts

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Zahra A. Barandouzi, Ph.D.,MSN,RN

Role: primary

404-544-9078

Zahra A. Barandouzi, Ph.D.,MSN,RN

Role: primary

404-544-9078

Zahra A. Barandouzi, Ph.D.,MSN,RN

Role: primary

404-544-9078

Zahra A. Barandouzi, Ph.D.,MSN,RN

Role: primary

404-544-9078

Other Identifiers

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P30CA138292

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2024-08387

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU6320-24

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00007783

Identifier Type: -

Identifier Source: org_study_id

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