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

Launched by OHSU KNIGHT CANCER INSTITUTE · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial, called iLIVE, is looking at how an online program that combines weight loss and resistance training can help men with prostate cancer who have undergone hormone therapy, known as androgen deprivation therapy (ADT). ADT can lead to weight gain and frailty, which may make it harder for these men to maintain their quality of life and increase their chances of falling. By participating in the iLIVE program, researchers hope to see improvements in both weight and physical strength, ultimately helping these men live healthier lives.

To be eligible for this trial, participants must be at least 18 years old, have been diagnosed with prostate cancer, and have received hormone therapy for at least six months in the past decade. They should also be overweight or obese and show signs of frailty, like weakness or fatigue. Participants will need a reliable internet connection for online sessions and must not be currently engaged in structured diet or exercise programs. If you or someone you know fits these criteria, this trial could offer a valuable opportunity to improve health after prostate cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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