Remote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas

FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma Clinical Trial

Official title:

RISE: Remote Intervention for Strength Training in Endometrial Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213571
• Other study ID #: 23-008883
• Secondary ID: NCI-2023-1109623
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Endometrioid
• Endometrial Neoplasms
• FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
• FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
• Stage IA Uterine Corpus Cancer AJCC v8
• Stage IB Uterine Corpus Cancer AJCC v8

Intervention

Other:
• Exercise Counseling
Participate in exercise coaching sessions
• Exercise Intervention
Participate in home-based exercise program
• Health Promotion and Education
Receive resistance band and exercise booklets
• Interview
Ancillary studies
• Physical Performance Testing
Ancillary studies
• Questionnaire Administration
Ancillary studies
• Telemedicine
Participate in sessions remotely

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of participants	Assessed by the number of patients who complete 75% or more of the twice weekly exercise program.	Up to 2 years
Primary	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
Primary	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 2 years
Secondary	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 after completion of intervention

External Links

•   Mayo Clinic Clinical Trials