Prostate Cancer Clinical Trial

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

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.

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Full 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 OBJECTIVES:

I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice

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.

View Eligibility Criteria

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: Overweight but not class III morbidly obese (Body mass index [BMI] > 25 kg/m^2 to BMI < 50)
INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or unexpected weight loss
INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or 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 review of an information sheet

Exclusion Criteria:

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

Study is for people with:

Prostate Cancer

Estimated Enrollment:

250

Study ID:

NCT06011499

Recruitment Status:

Not yet recruiting

Sponsor:

OHSU Knight Cancer Institute

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There are 2 Locations for this study

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University of Alabama
Birmingham Alabama, 35294, United States More Info
Wendy Demark-Wahnefried, PhD
Contact
Wendy Demark-Wahnefried, PhD
Principal Investigator
OHSU Knight Cancer Institute
Portland Oregon, 97239, United States More Info
Kerri Winters-Stone
Contact
503-494-0813
[email protected]
Kerri Winters-Stone
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

250

Study ID:

NCT06011499

Recruitment Status:

Not yet recruiting

Sponsor:


OHSU Knight Cancer Institute

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