- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06213571
Remote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas
RISE: Remote Intervention for Strength Training in Endometrial Cancer
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 50+
- Stage IA-IB endometrial cancer
- Grade 1-2 disease
- No recurrence documented
- Internet access
- Access to a remote device with a camera such as a computer, smartphone or tablet
- > 1 year but less than 5 years from surgery
- Primary residence in rural-urban commuting area (RUCA) (rural-urban commuting area) codes 4.0 through 10.0 or of American Indian, Alaskan Native, Black or Hispanic background
Exclusion Criteria:
- Paraplegia/hemiplegia
- No English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supportive Care (home-based exercise program)
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.
|
Ancillary studies
Ancillary studies
Ancillary studies
Other Names:
Participate in exercise coaching sessions
Participate in home-based exercise program
Receive resistance band and exercise booklets
Participate in sessions remotely
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with program - self-reported
Time Frame: 10 weeks
|
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
|
|
Retention of participants
Time Frame: Up to 6 months
|
Assessed by the number of patients who complete 75% or more of the twice weekly exercise program.
|
Up to 6 months
|
|
Feasibility of intervention
Time Frame: Up to 6 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in physical function
Time Frame: Baseline; 10 weeks (end of exercise intervention); 6 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amanika A Kumar, MD, Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neoplasms by Histologic Type
- Uterine Diseases
- Genital Diseases, Female
- Neoplasms, Glandular and Epithelial
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Carcinoma
- Uterine Neoplasms
- Ovarian Neoplasms
- Adenocarcinoma
- Endometrial Neoplasms
- Carcinoma, Endometrioid
- Health Services Administration
- Delivery of Health Care
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Health Services
- Health Care Facilities Workforce and Services
- Preventive Health Services
- Socioeconomic Factors
- Population Characteristics
- Diagnostic Techniques, Respiratory System
- Diagnostic Techniques, Cardiovascular
- Patient Care Management
- Heart Function Tests
- Respiratory Function Tests
- Ergometry
- Health Education
- Interviews as Topic
- Educational Status
- Telemedicine
- Exercise Test
- Health Promotion
Other Study ID Numbers
- 23-008883 (Other Identifier: Mayo Clinic in Rochester)
- NCI-2023-11096 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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