Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
NCT ID: NCT06011499
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2024-03-12
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Internet-Based Exercise Intervention
Participate in online supervised, group resistance training sessions (iLIVE)
Internet-Based Diet Intervention
Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
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.
Education Intervention
Receive usual care receiving educational information about diet and exercise for cancer survivors
Interventions
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Internet-Based Exercise Intervention
Participate in online supervised, group resistance training sessions (iLIVE)
Internet-Based Diet Intervention
Receive online access to an interactive website with a series of weekly self-directed and interactive sessions on various topics associated with diet and weight loss (iLIVE)
Education Intervention
Receive usual care receiving educational information about diet and exercise for cancer survivors
Eligibility Criteria
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Inclusion Criteria
* 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: 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Oregon Health and Science University
OTHER
University of Alabama at Birmingham
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Kerri Winters
Principal Investigator
Principal Investigators
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Kerri Winters-Stone
Role: PRINCIPAL_INVESTIGATOR
OHSU Knight Cancer Institute
Locations
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University of Alabama
Birmingham, Alabama, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Wendy Demark-Wahnefried, PhD
Role: primary
Other Identifiers
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NCI-2023-03141
Identifier Type: REGISTRY
Identifier Source: secondary_id
STUDY00025281
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00025281
Identifier Type: -
Identifier Source: org_study_id
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