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

Trial Summary

What is the purpose of this trial?

The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations. The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer. The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients 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 data supports the effectiveness of the CARE-PC Web-Based Application treatment for cardiovascular care in prostate cancer?

The effectiveness of web-based tools in prostate cancer care is supported by studies showing that electronic patient-reported outcomes (ePRO) can improve communication with doctors and enhance patient health. Additionally, decision aids like the Personal Patient Profile-Prostate (P3P) have been shown to reduce decisional conflict in prostate cancer patients, suggesting that similar web-based applications could be beneficial. ^{1 2 3 4 5}

How does the web-based tool for cardiovascular care in prostate cancer differ from other treatments?

This web-based tool is unique because it focuses on electronic patient-reported outcomes and holistic needs assessment, allowing for personalized and continuous care through remote monitoring and support, unlike traditional paper-based methods. ^{3 6 7 8 9}

Research Team

Vivek K. Narayan

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Decision Support with the Personal Patient Profile-Prostate: A Multicenter Randomized Trial. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcome (ePRO) application for patients with prostate cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Receipt of best care according to current quality of care measures and outcomes in men with prostate cancer. [2021]

5. England 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. [2022]

6. England 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. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Prostate Cancer-Specific Holistic Needs Assessment (CHAT-P): Multimethod Study From Concept to Clinical Practice. [2022]

8. England pubmed.ncbi.nlm.nih.gov

The Internet and prostate cancer patients: searching for and finding information. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Examining the Priorities, Needs and Preferences of Men with Metastatic Prostate Cancer in Designing a Personalised eHealth Exercise Intervention. [2022]