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De klinische studie NCT06213571 voor FIGO Graad 1 Endometrium Endometrioïde Adenocarcinoom, FIGO Graad 2 Endometrium Endometrioïde Adenocarcinoom, Stadium IA baarmoederkanker AJCC v8, Stadium IB baarmoederkanker AJCC v8 is actief, niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Mayo KliniekRemote Home-Based Exercise Program for Strength Training in Endometrial Cancer Survivors in Rural Areas
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De klinische studie NCT06213571 is een interventioneel studie bij FIGO Graad 1 Endometrium Endometrioïde Adenocarcinoom, FIGO Graad 2 Endometrium Endometrioïde Adenocarcinoom, Stadium IA baarmoederkanker AJCC v8, Stadium IB baarmoederkanker AJCC v8 met de status actief, niet rekruterend. Het doel is om 80 deelnemers te includeren vanaf 22 maart 2024. De studie wordt geleid door Mayo Kliniek en de voltooiing is gepland op 31 maart 2026. Laatste update op ClinicalTrials.gov: 6 augustus 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel
RISE: Remote Intervention for Strength Training in Endometrial Cancer
Aandoeningen
FIGO Graad 1 Endometrium Endometrioïde AdenocarcinoomFIGO Graad 2 Endometrium Endometrioïde AdenocarcinoomStadium IA baarmoederkanker AJCC v8Stadium IB baarmoederkanker AJCC v8Andere studie-ID's
- 23-008883
- NCI-2023-11096 (Register-ID) (CTRP (Clinical Trial Reporting Program))
- 23-008883 (Overige identificatiecode) (Mayo Clinic in Rochester)
NCT-ID
Startdatum (Werkelijk)
2024-03-22
Laatste update geplaatst
2025-08-06
Verwachte einddatum
2026-03-31
Inschrijving (Geschat)
80
Studietype
Interventioneel
FASE
N.v.t.
Status
Actief, niet rekruterend
Primaire doel
Ondersteunende zorg
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelSupportive 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. | Oefenadvies Participate in exercise coaching sessions Oefeninterventie Participate in home-based exercise program Gezondheidsbevordering en educatie Receive resistance band and exercise booklets Interview Ancillary studies Testen van fysieke prestaties Ancillary studies Vragenlijstadministratie Ancillary studies Telemedicine Participate in sessions remotely |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Retention of participants | Assessed by the number of patients who complete 75% or more of the twice weekly exercise program. | Up to 2 years |
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 2 years |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
50 Years
Geslachten die in aanmerking komen voor de studie
Vrouw
- 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
- Paraplegia/hemiplegia
- No English speaking
Mayo Kliniek868 actieve klinische studies om te verkennenGeen contactgegevens beschikbaar
1 Studielocaties in 1 landen
Minnesota
Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States