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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA275055 | U.S. NIH Grant/Contract | View source | |
| NCI-2023-03141 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| STUDY00025281 | Other Identifier | OHSU Knight Cancer Institute |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Oregon Health and Science University | OTHER |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (iLIVE) | Experimental | 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. |
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| Arm II (usual care) | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-Based Exercise Intervention | Other | Participate in online supervised, group resistance training sessions (iLIVE) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in overweight/obesity | Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index > 25 kg/m^2 and a 5% loss will be viewed as a successful outcome. | At baseline, 3 months, 6 months and 12 months |
| Change in sarcopenia | Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of < 10.75 kg/m^2 (moderate sarcopenia). | At baseline and 6 months |
| Change in slowness | Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed < 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence. | At baseline, 3 months and 6 months |
| Change in weakness | Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time > 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness." | At baseline, 3 months, and 6 months |
| Change in inactivity | Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use < 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit. | At baseline, 3 months, 6 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health behaviors | Dietary intake measured using a 2-day diet recalls of 1-weekday and 1 weekend day will be collected by a registered dietitian via telephone and entered into the National Cancer Institute-developed Automated Self-Administered 24-hour. Physical activity measured using CHAMPS as described above. We will also assess free-living physical activity over 7-days using Fitbits. | At baseline, 3 months, 6 months, and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Guidarelli, MPH | Contact | 503-346-0307 | borsch@ohsu.edu | |
| Sharon McCoy, MS | Contact | 503-494-1676 | mccoys@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kerri Winters-Stone, PhD | OHSU Knight Cancer Institute | Principal Investigator |
| Wendy Demark-Wahnefried, PhD, RD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Recruiting | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41882641 | Derived | Demark-Wahnefried W, Rogers LQ, Zubkoff L, Pisu M, Hung A, Graff JN, Hamilton J, Dieckmann NF, Winters-Stone K. Protocol for the internet-based lifestyle intervention to eradicate obese frailty in prostate cancer survivors (iLIVE) randomized controlled trial: a type I hybrid effectiveness implementation trial. BMC Cancer. 2026 Mar 25;26(1):559. doi: 10.1186/s12885-026-15851-4. |
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All individual quantitative participant data collected during the trial, after deidentification.
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Beginning 3 months following final publication
Access will be provided to investigators who provide a methodologically sound proposal and complete a data sharing agreement that includes commitments to: (1) using the data only for research purposes and not to identify any individual participant, (2) securing the data using appropriate computer technology, and (3) destroying or returning the data after analyses are completed.
Proposals should be directed to wintersk@ohsu.edu. To gain access to data, data requestors will need to sign a data sharing agreement.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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
| Internet-Based Diet Intervention | Other | 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) |
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| Education Intervention | Other | Receive usual care receiving educational information about diet and exercise for cancer survivors |
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| Change in fatigue | Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of < 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years. | At baseline, 3 months, 6 months, and 12 months |
| Change in physical functioning | Measured by Timed Up and Go using a widely used clinical measure of functional mobility that evaluates the time it takes to rise from a chair, walk 3m, turn around, and return and sit in the chair. SF-36 Physical Function measured using a 10-item physical function subscale of the SF-36. | At baseline, 3 months, 6 months, 12 months |
| Change in quality of life | Measured by European Quality of Life-5D with 1 question in 5 separate domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will also be used to calculate Quality of Life Adjusted Years for cost-effectiveness analysis. Healthcare utilization measured using a brief questionnaire that assesses physician and emergency room visits, hospitalizations, etc. | At baseline, 3 months, 6 months, and 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011314 | Preventive Health Services |