Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Emory University
- Enrollment
- 40
- Locations
- 4
- Primary Endpoint
- Attrition Rates (Feasibility)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Exercise Intervention (Other)
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.
Intervention: Functional Assessment (Other)
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.
Intervention: Medical Device Usage and Evaluation (Other)
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.
Intervention: Questionnaire Administration (Other)
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.
Intervention: Supportive Care (Other)
Outcomes
Primary Outcomes
Attrition Rates (Feasibility)
Time Frame: At 12 weeks
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.
Adherence Rates (Feasibility)
Time Frame: At 12 weeks
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.
Intervention Acceptability
Time Frame: Up to 12 weeks
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.
Gut Microbiome
Time Frame: From baseline to 12 weeks
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.
Psychoneurological Symptoms
Time Frame: From baseline to 12 weeks
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.
Secondary Outcomes
- Rapid Eating Assessment for Participants(Up to 12 weeks)
- Stress(Up to 12 weeks)
- Quality of Life Assessment(Up to 12 weeks)
- Rapid Eating Assessment for Participants(Up to 12 weeks)
- Stress(Up to 12 weeks)
Investigators
Zahra A. Barandouzi
Principal Investigator
Emory University