250 Participants Needed

Internet-Based Lifestyle Intervention for Prostate Cancer Survivors

(iLIVE Trial)

Recruiting at 1 trial location
CG
SM
Overseen BySharon McCoy, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: OHSU Knight Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment iLIVE for prostate cancer survivors?

Research suggests that web-based lifestyle interventions, like iLIVE, can help prostate cancer survivors improve their physical activity and diet, which may enhance their quality of life and prognosis. These interventions are accessible and can be tailored to individual needs, making them a promising option for supporting healthier lifestyle habits.12345

Is the Internet-Based Lifestyle Intervention safe for prostate cancer survivors?

The research does not provide specific safety data for the Internet-Based Lifestyle Intervention, but it suggests that digital health coaching and web-based lifestyle interventions are generally considered feasible and promising for improving health outcomes in prostate cancer survivors.15678

How is the iLIVE treatment different from other treatments for prostate cancer survivors?

The iLIVE treatment is unique because it is an internet-based lifestyle intervention specifically designed to help prostate cancer survivors improve their physical activity and dietary habits, which can enhance their quality of life and prognosis. Unlike traditional treatments, it leverages the internet to provide scalable and accessible support, making it easier for survivors to adopt healthier lifestyles.12569

Research Team

Winters-Stone Exercise Lab | OHSU

Kerri Winters-Stone

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for English-speaking men over 18 with prostate cancer who've had at least 6 months of ADT in the past decade, are obese but not morbidly so (BMI >30 to <50), show signs of frailty, and have internet access. They shouldn't be on a diet or exercise plan, have other active cancers except non-melanoma skin cancer, or any condition that affects weight/body composition like Cushing's syndrome.

Inclusion Criteria

I do not plan to start additional cancer treatment within 6 months.
I have undergone hormone therapy for at least 6 months in the past decade.
Verbal informed consent following review of an information sheet
See 10 more

Exclusion Criteria

Contraindication to moderate intensity exercise
I have an active cancer other than non-melanoma skin cancer.
I have lost more than 5% of my weight without trying in the last year.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive online access to an interactive weight loss website and participate in online group-based resistance training sessions (iLIVE). They also use a Fitbit fitness tracker and Aria smart scale.

6 months
Online sessions and self-monitoring

Follow-up

Participants are monitored for changes in obesity, frailty, and other health outcomes after the intervention.

6 months
Remote assessments at 3, 6, and 12 months

Treatment Details

Interventions

  • iLIVE
Trial OverviewThe iLIVE program is being tested to see if it can help reduce obesity and improve frailty in prostate cancer survivors treated with ADT. It includes an online weight loss plus resistance training intervention compared against standard care through random assignment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (iLIVE)Experimental Treatment2 Interventions
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 smart scale while on study.
Group II: Arm II (Usual care)Active Control1 Intervention
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.

iLIVE is already approved in United States for the following indications:

🇺🇸
Approved in United States as iLIVE for:
  • Obesity and frailty in prostate cancer survivors

Find a Clinic Near You

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials
239
Recruited
2,089,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

University of Alabama at Birmingham

Collaborator

Trials
1,677
Recruited
2,458,000+

Findings from Research

The Community of Wellness is a Web-based intervention designed to support prostate cancer survivors in improving their physical activity and dietary habits, with a randomized controlled trial currently enrolling 200 participants to assess its feasibility and acceptability.
Preliminary results will help determine the most effective level of online support needed to promote health behavior changes in men with prostate cancer, potentially informing future scalable health interventions.
Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial.Winters-Stone, KM., Kenfield, SA., Van Blarigan, EL., et al.[2020]
A randomized controlled trial involving 249 prostate and colorectal cancer survivors found that a computer-tailored physical activity intervention, offering both Web-based and print materials, was effective, with 84.9% of participants using the Web-based resources.
The study highlighted that older, less educated, and more fatigued participants were less likely to engage with Web-based materials, suggesting that providing both delivery modes is crucial to ensure accessibility for all survivors, especially those who may benefit the most from physical activity interventions.
A Web-Based and Print-Based Computer-Tailored Physical Activity Intervention for Prostate and Colorectal Cancer Survivors: A Comparison of User Characteristics and Intervention Use.Golsteijn, RHJ., Bolman, C., Peels, DA., et al.[2018]
The web-based intervention RiseTx successfully reduced sedentary time by an average of 455.4 weekly minutes and increased moderate-to-vigorous physical activity by 44.1 weekly minutes among 46 prostate cancer survivors over a 12-week period.
Participants reported high satisfaction with the intervention, indicating its feasibility; however, additional strategies may be necessary to maintain these behavior changes in the long term.
RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy.Trinh, L., Arbour-Nicitopoulos, KP., Sabiston, CM., et al.[2018]

References

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. [2020]
A Web-Based and Print-Based Computer-Tailored Physical Activity Intervention for Prostate and Colorectal Cancer Survivors: A Comparison of User Characteristics and Intervention Use. [2018]
RiseTx: testing the feasibility of a web application for reducing sedentary behavior among prostate cancer survivors receiving androgen deprivation therapy. [2018]
Demographic and Psychosocial Characteristics Associated With Use of a Prostate Cancer Survivorship Website: Implications From a Multisite Randomized Controlled Trial. [2022]
Web-Based Lifestyle Interventions for Prostate Cancer Survivors: Qualitative Study. [2020]
Examining the accessibility of high-quality physical activity behaviour change support freely available online for men with prostate cancer. [2019]
A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. [2022]
Active for Life After Cancer: a randomized trial examining a lifestyle physical activity program for prostate cancer patients. [2022]
The Effects of Multimodal Prehabilitation Interventions in Men Affected by Prostate Cancer on Physical, Clinical and Patient Reported Outcome Measures: A Systematic Review. [2022]