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FIGO Grade 1 Endometrial Endometrioid AdenocarcinomaNCT06213571

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

A study testing Exercise Counseling, Exercise Intervention and Health Promotion and Education in people with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 years and older, women only
What is being tested?
Exercise Counseling, Exercise Intervention and Health Promotion and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
22 Mar 2024to 3 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Paraplegia/hemiplegia
  • No English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: RISE: Remote Intervention for Strength Training in Endometrial Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Exercise Counseling, Exercise Intervention, Health Promotion and Education, Interview, Physical Performance Testing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise CounselingOther

    Participate in exercise coaching sessions

  • Exercise InterventionOther

    Participate in home-based exercise program

  • Health Promotion and EducationOther

    Receive resistance band and exercise booklets

  • InterviewOther

    Ancillary studies

  • Physical Performance TestingOther

    Also called Physical Fitness Testing, Physical Function Testing

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

  • TelemedicineOther

    Also called Telehealth

    Participate in sessions remotely

Study groups in NCT06213571
Study groupRoleWhat they receive
Supportive Care (home-based exercise program)ExperimentalParticipants 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.
Receives: Other: Exercise Counseling; Other: Exercise Intervention; Other: Health Promotion and Education; Other: Interview; Other: Physical Performance Testing; Other: Questionnaire Administration; Other: Telemedicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention of participants

    Assessed by the number of patients who complete 75% or more of the twice weekly exercise program.

    Measured: Up to 6 months

  2. 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.

    Measured: 10 weeks

  3. 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

    Measured: Up to 6 months

Secondary outcomes (1)

  1. 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).

    Measured: Baseline; 10 weeks (end of exercise intervention); 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2024
  2. Study start22 Mar 2024
  3. Primary completion3 Feb 2026
  4. Study completion3 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06213571
Sponsor's protocol ID
23-008883
Status last verified
Jun 2026
First submitted
10 Jan 2024
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Counseling, Exercise Intervention and Health Promotion and Education in people with FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma and FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention of participants (time frame: Up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06213571.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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