Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• INTERVENTION PARTICIPANTS: Age 18 or older

• INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer

• INTERVENTION PARTICIPANTS: Received \>= 6 months of ADT any time in the past 10 years

• INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \> 6 weeks prior to

• INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment

• INTERVENTION PARTICIPANTS: Overweight or obese (body mass index \> 25 kg/m2 to BMI ≤ 50).

• INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness

• INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program

• INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol

• INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing

• INTERVENTION PARTICIPANTS: Signed informed consent

• IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\])

• IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet

Locations
United States
Alabama
University of Alabama
NOT_YET_RECRUITING
Birmingham
Oregon
OHSU Knight Cancer Institute
RECRUITING
Portland
Contact Information
Primary
Carolyn Guidarelli, MPH
borsch@ohsu.edu
503-346-0307
Backup
Sharon McCoy, MS
mccoys@ohsu.edu
503-494-1676
Time Frame
Start Date: 2024-03-12
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 250
Treatments
Experimental: Arm I (iLIVE)
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 smart scale while on study.
Active_comparator: Arm II (usual care)
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.
Related Therapeutic Areas
Sponsors
Leads: OHSU Knight Cancer Institute
Collaborators: Oregon Health and Science University, University of Alabama at Birmingham, National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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