Clinical trial NCT06709534: An Individualized Online Home-Based Exercise Program for Improving Symptoms in Disadvantaged Gynecologic Cancer Survivors
Official title: Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Disadvantaged Gynecologic Cancer Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malignant Female Reproductive System Neoplasm
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial tests an individualized online home-based exercise program in disadvantaged 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 with low SES 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 with low SES. An individualized online home-based exercise program may be feasible, and may improve symptoms and quality of life in disadvantaged 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 with low SES.

II. To test the effect of the program on gut microbiome and psychoneurological symptoms in gynecologic cancer survivors with low SES.

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.

Eligibility criteria: Inclusion Criteria:

* Women aged ≥ 18 years old
* Previously diagnosed with gynecologic cancer (e.g., uterine, ovarian, cervical)
* Enrolled in Medicaid (as a factor to determine a low SES)
* 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
* Had surgery (including gynecologic surgery) within the past six weeks
* Are currently participating in a regular physical activity program (regular ≥ 3 times/week moderate-intensity exercise)

Primary outcomes:
measure: Attrition rates (Feasibility)
timeFrame: At 12 weeks
measure: Adherence rates (Feasibility)
timeFrame: At 12 weeks
measure: Intervention acceptability
timeFrame: Up to 12 weeks
measure: Gut microbiome
timeFrame: From baseline to 12 weeks
measure: Psychoneurological symptoms
timeFrame: From baseline to 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: Up to 12 weeks
measure: Rapid Eating Assessment for Participants
timeFrame: Up to 12 weeks
measure: Stress
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Decatur
country: United States
facility: Emory Decatur Hospital
state: Georgia
Study officials:
affiliation: Emory University Hospital/Winship Cancer Institute
name: Zahra A Barandouzi, Ph.D., RN
role: PRINCIPAL_INVESTIGATOR
References: