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Recruiting NCT06709534

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

No phase Interventional Malignant Female Reproductive System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise Intervention, Functional Assessment, Medical Device Usage and Evaluation, Questionnaire Administration.
Who it may be relevant to
Registry conditions: Malignant Female Reproductive System Neoplasm. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Other Exercise Intervention
    Participate in an individualized online home-based exercise intervention
  • Other Functional Assessment
    Complete functional capacity assessment
  • Other Medical Device Usage and Evaluation
    Wear an activity tracker
  • Other Questionnaire Administration
    Ancillary studies
  • Other Supportive Care
    Receive social support

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Quality of Life Assessment [Time frame: Up to 12 weeks]
  • Rapid Eating Assessment for Participants [Time frame: Up to 12 weeks]
  • Stress [Time frame: Up to 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 4 centers
  • Grady Health System — Atlanta
  • Emory University Hospital Midtown — Atlanta
  • Emory University Hospital/Winship Cancer Institute — Atlanta
  • Emory Decatur Hospital — Decatur

Identifiers

NCT: NCT06709534 · STUDY00007783 · P30CA138292 · NCI-2024-08387 · EU6320-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗