NCT06709534|Recruiting

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

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

Emory University ClinicalTrials.gov

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4 other identifiers

STUDY00007783P30CA138292NCI-2024-08387EU6320-24

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredNov 2024

StartedSep 2025

CompletionJul 2027

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

15mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach

1 country

4 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Progress36%

Sep 2025Jul 2027

First Submitted

Initial submission to the registry

October 25, 2024

Completed

1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed

9 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

October 25, 2024

Last Update Submit

September 4, 2025

Conditions

Malignant Female Reproductive System Neoplasm

Outcome Measures

Primary Outcomes (5)

Attrition Rates (Feasibility)
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)
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
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
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
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 Outcomes (3)

Quality of Life Assessment
Up to 12 weeks
Rapid Eating Assessment for Participants
Up to 12 weeks
Stress
Up to 12 weeks

Study Arms (1)

Supportive Care (individualized online home-based exercise)

EXPERIMENTAL

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: Exercise InterventionOther: Functional AssessmentOther: Medical Device Usage and EvaluationOther: Questionnaire AdministrationOther: Supportive Care