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

Emory University

Status: Enrolling

Conditions: Malignant Female Reproductive System Neoplasm

Treatments: Other: Functional Assessment; Other: Exercise Intervention; Other: Medical Device Usage and Evaluation; Other: Supportive Care; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06709534

STUDY00007783

P30CA138292 (U.S. NIH Grant/Contract)

EU6320-24 (Other Identifier)

NCI-2024-08387 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Supportive Care (individualized online home-based exercise)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Supportive Care

Other: Medical Device Usage and Evaluation

Other: Exercise Intervention

Other: Functional Assessment