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Trial Title:
Internet-Based Lifestyle Intervention (iLIVE) to Eradicate Obese Frailty in Prostate Cancer Survivors
NCT ID:
NCT06011499
Condition:
Prostate Carcinoma
Conditions: Official terms:
Frailty
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Outcomes assessors are blinded to participant group assignment after completing the
baseline assessment and prior to randomization. Adverse events will be reviewed on a
quarterly basis by the research team in a blinded fashion
Intervention:
Intervention type:
Other
Intervention name:
Internet-Based Exercise Intervention
Description:
Participate in online supervised, group resistance training sessions (iLIVE)
Arm group label:
Arm I (iLIVE)
Intervention type:
Other
Intervention name:
Internet-Based Diet Intervention
Description:
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 group label:
Arm I (iLIVE)
Intervention type:
Other
Intervention name:
Education Intervention
Description:
Receive usual care receiving educational information about diet and exercise for cancer
survivors
Arm group label:
Arm II (Usual care)
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.
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 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.
Criteria for 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 (BMI > 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Wendy Demark-Wahnefried, PhD
Investigator:
Last name:
Wendy Demark-Wahnefried, PhD
Email:
Principal Investigator
Facility:
Name:
OHSU Knight Cancer Institute
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kerri Winters-Stone
Phone:
503-494-0813
Email:
wintersk@ohsu.edu
Investigator:
Last name:
Kerri Winters-Stone
Email:
Principal Investigator
Start date:
April 2, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
OHSU Knight Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Oregon Health and Science University
Agency class:
Other
Collaborator:
Agency:
University of Alabama at Birmingham
Agency class:
Other
Source:
OHSU Knight Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011499
