Status:
RECRUITING
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Oregon Health and Science University
Conditions:
Prostate Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 andr...
Detailed Description
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 O...
Eligibility Criteria
Inclusion
- 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
Exclusion
- INTERVENTION PARTICIPANTS: Unintentional weight loss \> 5% within the last year
- INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
- INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
- INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
- INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
- INTERVENTION PARTICIPANTS: Currently taking or have taken creatine supplement in the month preceding baseline creatine testing
Key Trial Info
Start Date :
March 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06011499
Start Date
March 12 2024
End Date
December 31 2027
Last Update
May 31 2025
Active Locations (2)
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1
University of Alabama
Birmingham, Alabama, United States, 35294
2
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239