This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06011499.
Locations matching your search criteria
United States
Oregon
Portland
OHSU Knight Cancer InstituteStatus: Active
Contact: Carolyn Guidarelli
Phone: 503-346-0307
PRIMARY OBJECTIVE:
I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT.
SECONDARY OBJECTIVE:
I. To grasp iLIVE’s implementation context and outcomes.
OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes.
ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.
ARM II: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study.
Patients are followed for 6 months after completion of intervention.
Key stakeholders complete an interview while on study to assess barriers and facilitators to implementation of iLIVE into clinical practice.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationOHSU Knight Cancer Institute
Principal InvestigatorKerri Winters-Stone
