Malignant Female Reproductive System Neoplasm
Conditions
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.
Interventions
OTHERSupportive Care
Receive social support
OTHERExercise Intervention
Participate in an individualized online home-based exercise intervention
Complete functional capacity assessment
OTHERMedical Device Usage and Evaluation
Wear an activity tracker
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychoneurological Symptoms | 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. |
| Adherence Rates (Feasibility) | 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 | 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 | 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. |
| Attrition Rates (Feasibility) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rapid Eating Assessment for Participants | Up to 12 weeks | Rapid Eating Assessment for Participants will be used to evaluate their diet. Diet will be assessed to control this variable for measuring gut microbiome. |
| Stress | Up to 12 weeks | Stress level will be measured using PSS. The preliminary efficacy of the intervention on stress will be compared using a paired t-test. |
| Quality of Life Assessment | Up to 12 weeks | Quality of life will be assessed using the Short Form-8 questionnaire. The preliminary efficacy of the intervention on quality life will be compared using a paired t-test. |
Countries
United States
Contacts
Primary ContactZahra Barandouzi, Ph.D.,MSN,RN
Outcome results
None listed