Internet-Based Lifestyle Intervention for Prostate Cancer Survivors

(iLIVE Trial)

Recruiting at 1 trial location

Overseen By Sharon McCoy, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: OHSU Knight Cancer Institute

Disqualifiers: Unintentional weight loss, Cushing's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online program called iLIVE, which combines weight loss and resistance training to assist men with prostate cancer who have undergone androgen deprivation therapy (ADT). ADT often leads to weight gain and frailty, potentially lowering quality of life and increasing fall risk. The study aims to determine if iLIVE can address these issues. Men who have had prostate cancer, received ADT for at least six months, are overweight, and show signs of frailty, but are not currently on a structured diet or exercise program, may be suitable for this trial. Participants will either use the iLIVE program or receive usual care, both supported by fitness trackers. As an unphased trial, this study provides a unique opportunity to contribute to research that may improve quality of life for men with prostate cancer.

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 prior data suggests that this internet-based lifestyle intervention is safe for prostate cancer survivors?

Research shows that specific safety information for the iLIVE program, an online lifestyle intervention, is not available. However, similar digital health and web-based lifestyle programs have been well-received, and participants usually find them safe.

These studies often report high retention rates, indicating that participants tend to stay involved. For instance, one study showed that 85.4% of participants remained engaged at three weeks, increasing to 91% at 12 weeks. This suggests that people find the program easy to follow and safe.

In summary, while direct safety data for the iLIVE program is lacking, similar programs have proven safe for participants in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Internet-Based Lifestyle Intervention for prostate cancer survivors because it's a unique approach that combines digital tools and social support for health improvement. Unlike traditional care, which often focuses on in-person sessions and general health advice, this intervention offers personalized, interactive online weight loss programs and group-based resistance training. It leverages technology such as Fitbits and smart scales to provide real-time feedback and motivation, potentially enhancing engagement and adherence to lifestyle changes. This could lead to better long-term health outcomes for prostate cancer survivors by seamlessly integrating modern technology with healthy lifestyle practices.

What evidence suggests that iLIVE is effective for improving obesity and frailty in prostate cancer survivors?

Research shows that the iLIVE program, available to participants in this trial, combines online weight loss advice with group exercise and may help improve obesity and frailty in men with prostate cancer who have undergone hormone therapy. This therapy often leads to weight gain, weakness, and obesity, which can lower quality of life and increase fall risk. Studies suggest that lifestyle programs like iLIVE can promote healthier weight and strength. Early results from similar programs indicate improvements in physical health and potential reductions in frailty. Therefore, iLIVE offers a promising approach to enhancing the health of prostate cancer survivors facing these challenges. ^{1 2 6 7 8}

Who Is on the Research Team?

Kerri Winters-Stone

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• iLIVE

Trial Overview The 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.

How Is the Trial Designed?

Group I: Arm I (iLIVE) Experimental Treatment 2 Interventions

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 Control 1 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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 study involving 202 prostate cancer survivors explored the feasibility of a 12-week web-based lifestyle intervention, identifying five key factors that influenced participant engagement: environment, motivation, preparedness, program design, and program support.

The findings suggest that optimizing technology and health literacy, customizing program content, and leveraging support from healthcare providers and family can enhance the effectiveness of web-based interventions for prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Lifestyle Interventions for Prostate Cancer Survivors: Qualitative Study. Wang, EY., Graff, RE., Chan, JM., et al.[2020]

A 6-month group-based lifestyle program for prostate cancer patients did not lead to significant improvements in quality of life or physical activity levels, despite good attendance and positive reception from participants.

While the program improved several cognitive-behavioral skills related to physical activity, it was not effective enough to promote routine physical activity among the patients, indicating that additional strategies may be needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active for Life After Cancer: a randomized trial examining a lifestyle physical activity program for prostate cancer patients. Carmack Taylor, CL., Demoor, C., Smith, MA., et al.[2022]

In a study of 217 prostate cancer survivors, those who used the PROGRESS website were more likely to be older, non-Hispanic White, and had a monitoring style of coping, along with lower levels of depression, anxiety, and fatigue.

The findings suggest that personal characteristics, particularly race and emotional well-being, significantly influence the use of web-based resources for cancer survivorship, highlighting the need for targeted engagement strategies to reach diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demographic and Psychosocial Characteristics Associated With Use of a Prostate Cancer Survivorship Website: Implications From a Multisite Randomized Controlled Trial. Marziliano, A., Diefenbach, MA., Hudson, SV., et al.[2022]

Out of 45 websites evaluated for physical activity support for prostate cancer survivors, only 29% were rated as high quality, indicating that while some good resources exist, many are of lower quality.

Most websites lacked comprehensive information on physical activity guidelines for cancer survivors and did not offer adequate behavior change support, highlighting the need for better resources and improved accessibility for prostate cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the accessibility of high-quality physical activity behaviour change support freely available online for men with prostate cancer. Short, CE., Gelder, C., Binnewerg, L., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 17 studies involving 1739 participants found that multimodal prehabilitation interventions, which included physical activity, diet, and psychological support, can positively impact physical and clinical outcomes for men with prostate cancer.

There is significant variability in the design and implementation of these prehabilitation programs, highlighting the need for standardized approaches and the inclusion of partners in the care process to enhance support during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Multimodal Prehabilitation Interventions in Men Affected by Prostate Cancer on Physical, Clinical and Patient Reported Outcome Measures: A Systematic Review. Paterson, C., Roberts, C., Kozlovskaia, M., et al.[2022]

A pilot study involving 88 men with prostate cancer demonstrated that a 12-week digital health coaching program was feasible, with 71.6% of participants completing the program, exceeding the feasibility threshold of 60%.

The coaching program covered various topics relevant to prostate cancer management, indicating that digital health coaching could be a valuable tool for improving patient engagement and self-management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Feasibility Study of Digital Health Coaching for Men With Prostate Cancer. Handley, NR., Wen, KY., Gomaa, S., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03141

Internet-Based Lifestyle Intervention to Eradicate Obese ... Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT. Eligibility Criteria ...

2. reporter.nih.gov reporter.nih.gov/project-details/11112503

Project Details - NIH RePORTER This design allows formal testing of the effectiveness of a combined online, self-directed weight loss + group-based resistance training program (Internet-Based ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/464936

Internet-Based Lifestyle Intervention (iLIVE) to Eradicate ... Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and ...

4. cancer.jmir.org cancer.jmir.org/2020/2/e19362/

Web-Based Lifestyle Interventions for Prostate Cancer Survivors Objective: This study aims to develop a data-driven grounded theory of web-based engagement by prostate cancer survivors based on their ...

5. trialx.com trialx.com/clinical-trials/listings/291576/internet-based-lifestyle-intervention-ilive-to-eradicate-obese-frailty-in-prostate-cancer-survivors/

Internet-Based Lifestyle Intervention (iLIVE) to Eradicate ... Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and ...

6. withpower.com withpower.com/trial/phase-frailty-9-2023-e1e61

Internet-Based Lifestyle Intervention for Prostate Cancer ... The research does not provide specific safety data for the Internet-Based Lifestyle Intervention, but it suggests that digital health coaching and web-based ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07093177

Multimodal Telerehabilitation of Rural Patients With ... Prostate cancer has a significant impact on patient quality of life (QoL) directly, as well as through the management of localized disease (such as surgery ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8633161/

A Web-based Lifestyle Intervention for Cancer Survivors Recruitment was conducted with ease, and retention was high (85.4% at 3 weeks, slightly lower than the 91% retention rate found at 12 weeks in a web-delivered ...