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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA138292 | U.S. NIH Grant/Contract | View source | |
| NCI-2024-08387 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| EU6320-24 | Other Identifier | Emory University Hospital/Winship Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (individualized online home-based exercise) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Other | Participate in an individualized online home-based exercise intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Assessment | 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. | Up to 12 weeks |
| Rapid Eating Assessment for Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahra Barandouzi, Ph.D.,MSN,RN | Contact | 4045449078 | zahra.barandouzi@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Zahra A Barandouzi, Ph.D.,MSN,RN | Emory University Hospital/Winship Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Recruiting | Atlanta | Georgia | 30303 | United States |
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| Functional Assessment | Other | Complete functional capacity assessment |
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| Medical Device Usage and Evaluation | Other | Wear an activity tracker |
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| Questionnaire Administration | Other | Ancillary studies |
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| Supportive Care | Other | Receive social support |
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| From baseline 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. |
| Up to 12 weeks |
| Stress | Stress level will be measured using PSS. The preliminary efficacy of the intervention on stress will be compared using a paired t-test. | Up to 12 weeks |
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
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| Emory University Hospital/Winship Cancer Institute | Recruiting | Atlanta | Georgia | 30322 | United States |
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| Emory Decatur Hospital | Recruiting | Decatur | Georgia | 30033 | United States |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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