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This clinical trial studies how well a remotely delivered home-based exercise program for strength training works to positively impact endometrial cancer (EC) survivorship for patients with decreased cancer survivorship access. Cancer survivors in rural areas face barriers to supportive care, including geographic and environmental barriers to exercise and technology. Rural areas in the Midwest are underserved in terms of cancer care thus, it is essential to develop and test interventions that are scalable and can reach many individuals including those living in rural areas. Remotely-delivered exercise intervention approach allows for cancer survivors who may live far away from their primary treatment center to engage in supportive therapy via exercise interventions delivered in a sustainable context. In addition, historically black, hispanic and native endometrial cancer survivors have shorter survival and less access to survivorship care, so alternative models for healthcare delivery are needed in this underserved group. Information gained from this research may help determine whether utilizing a remotely delivered exercise program can positively impact EC survivorship for patients with decreased cancer survivorship access.
PRIMARY OBJECTIVES:
I. To develop and tailor a fully remote home-based exercise intervention for EC patients.
II. To test the recruitment and retention and acceptability of a fully remote home-based telehealth exercise intervention in older adult patients that live in rural America and are survivors of early stage, low risk endometrial cancer.
III. To measure the effectiveness of exercise intervention on quality of life in endometrial cancer patients, specifically in the realm of physical functioning.
OUTLINE:
Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study.
After completion of study intervention, patients are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (home-based exercise program) | Experimental | Participants participate in a home-based exercise program with an exercise prescription that will include resistance band and body weight exercises targeting the 5 major large muscle groups along with 3 booklets about exercise and exercise training and attend weekly exercise coaching sessions to report on exercise adherence and to progress exercise over 10 weeks on study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Counseling | Other | Participate in exercise coaching sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention of participants | Assessed by the number of patients who complete 75% or more of the twice weekly exercise program. | Up to 6 months |
| Satisfaction with program - self-reported | Assessed by a simple participant satisfaction survey after completion of the 10-week exercise intervention. Qualitative interviews will be performed at the completion of the program regardless of level of participation to assess facilitators, barriers, and motivators to participation. | 10 weeks |
| Feasibility of intervention | Technological questions and problems that arise during the exercise intervention will be recorded to assess the ability to fully perform telehealth exercise interventions in a rural cancer population | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in physical function | Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 6b assessment, a 6-item questionnaire answered on a scale from 5 (Without any difficulty or Not at all) to 0 (Unable to do or Cannot do). | Baseline; 10 weeks (end of exercise intervention); 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanika A Kumar, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Exercise Intervention | Other | Participate in home-based exercise program |
|
| Health Promotion and Education | Other | Receive resistance band and exercise booklets |
|
| Interview | Other | Ancillary studies |
|
| Physical Performance Testing | Other | Ancillary studies |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Telemedicine | Other | Participate in sessions remotely |
|
|
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D004522 | Educational Status |
| D007407 | Interviews as Topic |
| D005080 | Exercise Test |
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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