Feasibility and Acceptability of an Individualized Online Home-Based Exercise Program on Psychoneurological Symptoms in Gynecologic Cancer Survivors: A Pilot Study
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.
Arms & interventions
- OtherExercise Intervention
Participate in an individualized online home-based exercise intervention
- OtherFunctional Assessment
Complete functional capacity assessment
- OtherMedical Device Usage and Evaluation
Wear an activity tracker
- OtherQuestionnaire Administration
Ancillary studies
- OtherSupportive Care
Receive social support
Outcome measures
Primary
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to 12 weeks
Secondary
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
Study locations (4)
Grady Health System
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Decatur Hospital
Decatur, Georgia, 30033