Clinical trial NCT06213571: Remote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas
Official title: RISE: Remote Intervention for Strength Training in Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention of participants
timeFrame: Up to 2 years
measure: Satisfaction with program - self-reported
timeFrame: 10 weeks
measure: Feasibility of intervention
timeFrame: Up to 2 years
Secondary outcomes:
measure: Change in physical function
timeFrame: Baseline; 10 weeks (end of exercise intervention); 6 months after completion of intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Amanika A Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: