Web-Based Tool for Cardiovascular Care in Prostate Cancer

Overseen By Matthew Doyle

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Vivek Narayan

Must be taking: ADT

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool called the CARE-PC Web-Based Application, designed to help men with prostate cancer undergoing androgen deprivation therapy (ADT) understand and manage their heart health. The goal is to improve patient awareness of personal heart risks and provide ways to reduce those risks. Men with prostate cancer who are currently on ADT or will be on it for at least six months are suitable candidates for this trial. Participants will use the tool to learn about their cardiovascular risks and assess its impact on their care.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance heart health management 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.

What prior data suggests that this web-based tool is safe for cardiovascular education in prostate cancer patients?

Research has shown that the CARE-PC web app helps men with prostate cancer understand their risk of heart problems. This tool educates users about heart health risks and offers advice on reducing them.

Regarding safety, the app serves purely for learning and information. It doesn't involve taking new medications or undergoing medical procedures, so it poses no physical side effects or risks.

The main goal of this tool is to help prostate cancer patients better understand and manage their heart health. As an educational tool, it is considered very safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE-PC Web-Based Application because it offers a novel approach to managing cardiovascular health in men with prostate cancer undergoing androgen deprivation therapy (ADT). Unlike traditional treatments which primarily focus on hormone levels, this web-based tool provides personalized cardiovascular care by integrating digital health monitoring and patient education. By leveraging technology, it aims to empower patients to actively participate in their care, potentially improving overall health outcomes and quality of life. This innovative approach could set a new standard in supportive care for prostate cancer patients.

What evidence suggests that this web-based tool is effective for improving cardiovascular care in prostate cancer patients?

Research shows that online tools like the CARE-PC app can help patients better understand their heart health risks. In this trial, the CARE-PC app educates prostate cancer patients about their heart risks while on androgen deprivation therapy (ADT). Early results suggest that digital health tools can help patients manage these risks by providing personalized information and advice. Studies have found that when patients understand their health risks, they are more likely to take steps to reduce them. Overall, the CARE-PC app could play an important role in helping prostate cancer patients maintain heart health. ^{1 2 3 6 7}

Who Is on the Research Team?

Vivek K. Narayan

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for men over 18 with prostate cancer who are currently on or will start androgen deprivation therapy (ADT) for at least six months. Participants need to be able to read and understand English.

Inclusion Criteria

Patients must be able to read and understand English.

Exclusion Criteria

n/a

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Web-Based Application Participation

Participants use a web-based tool to learn about cardiovascular risks and receive individualized risk estimates and mitigation recommendations

6 months

Online participation

Follow-up

Participants are monitored for changes in cardiovascular care and medication adjustments

18 months

What Are the Treatments Tested in This Trial?

Interventions

• CARE-PC Web-Based Application

Trial Overview The CARE-PC study is testing a web-based application designed to educate prostate cancer patients about their cardiovascular risks associated with ADT, provide personalized risk assessments, and offer guidelines for risk reduction.

How Is the Trial Designed?

Group I: Men With Prostate Cancer Planned for Receiving ADT Experimental Treatment 1 Intervention

Men with prostate cancer \> 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of systemic androgen deprivation therapy (ADT).

Who Is Running the Clinical Trial?

Vivek Narayan

Lead Sponsor

Trials

1

Recruited

100+

National Comprehensive Cancer Network

Collaborator

Trials

121

Recruited

7,400+

Published Research Related to This Trial

The Composite Holistic Needs Assessment Adaptive Tool-Prostate (CHAT-P) was developed through a collaborative process involving men with prostate cancer and healthcare professionals, ensuring it meets the specific needs of patients and enhances cancer care delivery.

Initial testing with 16 patients showed that CHAT-P is user-friendly and acceptable, empowering men to communicate their concerns effectively before consultations, while also identifying critical psychological issues and symptoms that require urgent attention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Prostate Cancer-Specific Holistic Needs Assessment (CHAT-P): Multimethod Study From Concept to Clinical Practice. Nanton, V., Appleton, R., Ahmed, N., et al.[2022]

Eighteen Australian men with metastatic prostate cancer expressed a need for better understanding and support regarding exercise, with many not discussing it with their healthcare providers, highlighting a gap in communication and education.

Participants found a proposed web-based exercise intervention acceptable due to its affordability and convenience, emphasizing the importance of user-friendly design and professional support for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining the Priorities, Needs and Preferences of Men with Metastatic Prostate Cancer in Designing a Personalised eHealth Exercise Intervention. Evans, HEL., Forbes, CC., Vandelanotte, C., et al.[2022]

In a study of 511 prostate cancer patients, only 16% reported searching for information about their condition online, highlighting a gap in Internet use among this population.

Younger and more educated men were more likely to use the Internet for health information, suggesting that access to online resources may contribute to social inequalities in healthcare information access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Internet and prostate cancer patients: searching for and finding information. Buntrock, S., Hopfgarten, T., Adolfsson, J., et al.[2018]

The web-based application ePATH was found to be user-friendly and effective in supporting self-care for 15 men recovering from prostate cancer surgery, providing easy access to reliable rehabilitation information.

Patients appreciated the tailored information and logical structure of ePATH, but noted that unclear organization could decrease their motivation to use the app, highlighting the importance of clear design in digital health tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' experiences of using an e-Health tool for self-management support after prostate cancer surgery: a deductive interview study explained through the FITT framework. Nilsson, L., Hellström, A., Wennerberg, C., et al.[2021]

The study developed an electronic registry to monitor men on active surveillance for prostate cancer at a safety-net hospital, aiming to improve adherence to follow-up care and reduce the number of patients lost to follow-up.

By engaging clinic staff in the design process, the registry is tailored to meet specific needs, potentially demonstrating its feasibility for implementation in various healthcare settings and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An electronic registry to improve adherence to active surveillance monitoring among men with prostate cancer at a safety-net hospital: protocol for a pilot study. Cedars, B., Lisker, S., Borno, HT., et al.[2022]

The web-based P3P decision aid significantly reduced decisional conflict in men with localized prostate cancer compared to usual care, with a notable decrease of 5 points on the decisional conflict scale in the intervention group.

In a study involving 392 men, the P3P aid proved effective in enhancing shared decision-making, with additional factors like income and risk classification influencing the level of decisional conflict experienced by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Support with the Personal Patient Profile-Prostate: A Multicenter Randomized Trial. Berry, DL., Hong, F., Blonquist, TM., et al.[2019]

A smartphone application was developed for prostate cancer patients to electronically report their health outcomes, which was evaluated by 21 patients and 10 specialists, showing a high user satisfaction score of 5.95 out of 7.

The application aims to enhance communication between patients and healthcare providers, improve quality of care, and facilitate timely data collection, potentially reducing unnecessary treatment visits and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. Mohseni, M., Ayatollahi, H., Arefpour, AM.[2023]

In a study of 38,055 men with localized prostate cancer, only 9% received care that adhered to all five nationally endorsed quality measures, yet this did not lead to better outcomes in treatment-related morbidity or cancer control after five years.

Men who received best care were more likely to undergo procedures for sexual morbidity compared to those who did not receive best care, indicating that current quality measures may not effectively correlate with meaningful patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Receipt of best care according to current quality of care measures and outcomes in men with prostate cancer. Schroeck, FR., Kaufman, SR., Jacobs, BL., et al.[2021]

The study found that on-site electronic patient-reported outcomes (ePROs) were well-accepted by older men receiving treatment for advanced prostate cancer, with 90% finding the process easy and 80% preferring it over paper forms.

However, remote completion of ePROs was significantly more challenging, with only 20% successfully completing them, indicating a need for improved systems and support to enhance remote engagement for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Medicine in Men with Advanced Prostate Cancer - A Feasibility Study of Electronic Patient-reported Outcomes in Patients on Systemic Treatment. Appleyard, SE., Larkin, MJW., Stewart, EM., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06064149

Study Details | NCT06064149 | The CArdiovascular Risk ... The CARE-PC app is a pragmatic, patient-oriented, web-based application that enables the education of patients regarding cardiovascular (CV) risks and collects ...

2. withpower.com withpower.com/trial/phase-prostatic-neoplasms-9-2023-9ad97

Web-Based Tool for Cardiovascular Care in Prostate Cancer Trial Overview The CARE-PC study is testing a web-based application designed to educate prostate cancer patients about their cardiovascular risks associated ...

3. cancer.gov cancer.gov/clinicaltrials/NCI-2023-09968

Assessment of a Web-based Cardiovascular Risk Tool in ... The web-based tool educates patients of CV risks in prostate cancer and to inform them of individualized, estimated CV risk and guideline-based risk mitigation ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10203955/

Effectiveness of electronic patient reporting outcomes, by a ... The benefits of Electronic Patient -Reported Outcomes (e-PRO) for telemonitoring are well established, allowing early detection of illnesses and continuous ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT06064149/Prot_SAP_000.pdf

The CArdiovascular Risk Evaluation in Men with Prostate ... This protocol will 1) test the feasibility and acceptability of the CARE-PC web-based application and its impact on prostate cancer patient perceptions of CV ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345912/

Predicting Cardiovascular Risk in Patients with Prostate ... Prostate cancer patients receiving newer hormone treatments (abiraterone or enzalutamide) face an increased risk of heart problems, ...

7. ahajournals.org ahajournals.org/doi/abs/10.1161/circ.150.suppl_1.4140247

Abstract 4140247: Place and Race in Cardiovascular ... Men with prostate cancer (PC) frequently die of cardiovascular disease (CVD). Rurality has shown to increase adverse outcomes in PC men. 26 ...