NCT06213571

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 19, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 10, 2024

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (1)

  • Change in physical function

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

Study Arms (1)

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.

Other: Exercise CounselingOther: Exercise InterventionOther: Health Promotion and EducationOther: InterviewOther: Physical Performance TestingOther: Questionnaire AdministrationOther: Telemedicine

Interventions

Participate in exercise coaching sessions

Supportive Care (home-based exercise program)

Participate in home-based exercise program

Supportive Care (home-based exercise program)

Receive resistance band and exercise booklets

Supportive Care (home-based exercise program)

Ancillary studies

Supportive Care (home-based exercise program)

Ancillary studies

Also known as: Physical Fitness Testing, Physical Function Testing
Supportive Care (home-based exercise program)

Ancillary studies

Supportive Care (home-based exercise program)

Participate in sessions remotely

Also known as: Telehealth
Supportive Care (home-based exercise program)

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Paraplegia/hemiplegia
  • No English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Interventions

Health PromotionEducational StatusInterviews as TopicExercise TestTelemedicine

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation CharacteristicsData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Amanika A Kumar, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 19, 2024

Study Start

March 22, 2024

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

January 9, 2026

Record last verified: 2026-01

Locations