Decision-Making Support Tools for Prostate Cancer

Overseen By Marissa McPhaul

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Prior germline testing, others

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

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial explores and implements methods to improve informed decision making (IDM) regarding precision oncology tests amongst veterans with prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Precision oncology, the use of germline genetic testing and tumor-based molecular assays to inform cancer care, has become an important aspect of evidence-based care for men with advanced prostate cancer. Veterans with metastatic castrate-resistant prostate cancer may not be carrying out IDM due to unmet decisional needs. An informed decision is a choice based on complete and accurate information. The information gained from this study will help researchers develop a decision support intervention (DSI) and implement the intervention. A DSI may serve as a valuable tool to reduce ongoing racial disparities in genetic testing and encourage enrollment to precision oncology trials.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Mobile app, Participant Surveys, Lynparza, AZD-2281, MK-7339, KU0059436 for prostate cancer?

The research shows that decision support tools like the Personal Patient Profile-Prostate (P3P) help men with prostate cancer feel more prepared and satisfied with their treatment choices, reducing regret and improving alignment with treatment guidelines. ^{1 2 3 4 5}

Is there safety data available for the treatment options being considered in the clinical trial for prostate cancer?

The research articles discuss safety profiles of second-generation androgen receptor inhibitors for prostate cancer, highlighting that these treatments have different safety profiles, which means they may cause different side effects. However, specific safety data for the treatments named Mobile app, Participant Surveys, Lynparza, AZD-2281, MK-7339, or KU0059436 is not provided in the articles. ^{6 7 8 9 10}

How does the decision-making support tool for prostate cancer differ from other treatments?

The decision-making support tool for prostate cancer is unique because it provides personalized, interactive guidance to help patients make informed treatment decisions, reducing decisional conflict and regret. Unlike traditional treatments, this tool focuses on enhancing patient understanding and satisfaction by offering unbiased information and clarifying personal values. ^{1 11 12 13 14}

Research Team

Daniel Kwon, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for Veterans aged 18 or older with advanced prostate cancer, including those with pelvic lymph node-positive, metastatic, or castration-resistant types. Participants must speak and understand English, be able to follow the study procedures throughout its duration, and provide informed consent. Those involved in a patient's care can also join if they consent verbally.

Inclusion Criteria

I have an upcoming appointment to discuss genetic or tumor testing and targeted therapy.

I understand and can follow the study's procedures.

My prostate cancer is advanced, spread to lymph nodes, or resistant to hormone therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage I

Participants engage in discussions, complete surveys, and participate in interviews to evaluate decisional conflict and precision oncology knowledge.

6 months

Multiple visits (in-person and virtual)

Stage II

Development of a Decision Support Intervention (DSI) with participant interviews and advisory board participation.

6 months

Stage III

Implementation of the DSI, including decision aid platform selection, germline testing appointments, and follow-up surveys.

Up to 24 months

Scheduled germline testing appointment and follow-up

Follow-up

Participants are monitored for satisfaction and effectiveness of the decision support intervention.

6 months

Treatment Details

Interventions

• Mobile app
• Participant Surveys

Trial Overview The study aims to improve how Veterans make decisions about precision oncology treatments for advanced prostate cancer. It involves using participant surveys and a mobile app to gather data on decision-making processes regarding genetic testing and targeted therapies.

Participant Groups

Group I: Stage 3: Patients, Caregivers using developed GA platform Experimental Treatment 2 Interventions

About 14 days prior to scheduled germline testing appointment, patients and caregivers call or meet with a coach to select decision aid GA platform preference delivery (online, print, or both online and print), review the GA online platform, and possibly undergo consultation and training for audio recording of the scheduled appointment. Patients and caregivers attend the scheduled germline testing appointment on day 1. Patients complete surveys and patients and caregivers may complete an interview on study. Providers participate in focus groups and complete surveys on study.

Group II: CLOSED TO ENROLLMENT: Stage 1 & 2: Patients, Caregivers, Providers Experimental Treatment 2 Interventions

Patient participants will be instructed to install a mobile app to record their medical appointment, which research staff will use to analyze patient-provider communication. All participants will undergo semi-structured interviews and/or focus groups. Post appointment follow-up with surveys and assessments regarding knowledge of disease information, quality of life, and other measures will be administered after the provider-patient appointment.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

The Personal Patient Profile-Prostate (P3P) decision support system did not significantly impact patient outcomes such as perceived preparation for decision making, satisfaction, or decisional regret in men with localized prostate cancer.

Key factors influencing decision satisfaction and regret included pre-enrollment information, personal characteristics, and post-treatment symptoms, highlighting the importance of effective communication and preparation before treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. Berry, DL., Wang, Q., Halpenny, B., et al.[2022]

In a study of 295 men with prostate cancer, the use of the Personal Patient Profile-Prostate (P3P) decision support tool did not significantly increase the likelihood of pursuing guideline-concordant active surveillance for low-risk patients compared to usual care.

Factors such as Black race and having restricted treatment options were linked to lower rates of active surveillance among low-risk patients, highlighting disparities in treatment decisions rather than the effectiveness of the P3P tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk. Filson, CP., Hong, F., Xiong, N., et al.[2022]

The use of a novel web-based decision-making application for men with localized prostate cancer significantly reduced decisional conflict by 37%, indicating that patients felt more confident in their treatment choices after using the tool.

Patients who utilized the application reported feeling more included and jointly responsible for their treatment decisions, with 88% feeling included compared to 57% in the usual care group, highlighting the application's effectiveness in enhancing shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating Patient Preference into Treatment Decisions for Men with Prostate Cancer at the Point of Care. Johnson, DC., Mueller, DE., Deal, AM., et al.[2018]

The Spanish version of the Personal Patient Profile-Prostate (P3P) decision aid was tested with seven Latino men diagnosed with localized prostate cancer, revealing 25 unique usability issues that could hinder effective decision-making.

The study emphasizes that simply translating decision aids is not enough; they must be culturally and linguistically adapted and tested to ensure they effectively support patients in making informed treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability evaluation and adaptation of the e-health Personal Patient Profile-Prostate decision aid for Spanish-speaking Latino men. Berry, DL., Halpenny, B., Bosco, JLF., et al.[2021]

The Personal Patient Profile-Prostate (P4) is a customized, Internet-based decision support system designed for men with localized prostate cancer, successfully implemented in a pilot study with 30 participants.

Participants found the P4 program useful, and usage logs indicated a high engagement with its menu-driven components, suggesting its potential as a valuable tool in clinical decision-making for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actual use and perceived usefulness of a web-based, decision support program for men with prostate cancer. Berry, DL., Wolpin, SE., Lober, WB., et al.[2015]

A study involving 143 nmCRPC patients and 149 caregivers revealed that both groups prioritize treatments with lower risks of serious adverse events (AEs), particularly serious fractures and falls, over overall survival benefits.

Patients were willing to give up an average of 5.8 months of overall survival to avoid a 3% risk of serious fractures, indicating a strong preference for safety in treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and caregiver benefit-risk preferences for nonmetastatic castration-resistant prostate cancer treatment. Srinivas, S., Mohamed, AF., Appukkuttan, S., et al.[2021]

A study involving 77 cancer patients (37 with gynaecological cancer and 40 with prostate cancer) found that both electronic and paper formats of patient-reported toxicity questionnaires yielded consistent and reliable results in measuring treatment-related side effects after radiotherapy.

Patients generally found both formats clear and easy to use, with nearly half having no preference, indicating that electronic data capture for reporting toxicity is feasible and acceptable in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. Farnell, DJ., Routledge, J., Hannon, R., et al.[2022]

In a study involving 385 patients with non-castrate metastatic prostate cancer, it was found that physicians significantly under-reported adverse symptoms related to androgen deprivation therapy (ADT), with agreement rates for common symptoms like hot flushes and fatigue being only around 50-64%.

The failure of physicians to report patients' most disturbing symptoms ranged from 50.8% to 89.5%, highlighting the importance of incorporating patients' self-reports in clinical trials to better assess treatment toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). Gravis, G., Marino, P., Joly, F., et al.[2019]

In a study involving 149 physicians, it was found that doctors prioritize overall survival over time to pain progression when making treatment decisions for non-metastatic castration-resistant prostate cancer (nmCRPC).

Physicians were willing to trade significant months of overall survival—up to 9.1 months—to reduce severe cognitive problems and fatigue, highlighting the importance of balancing treatment benefits with the risks of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician preferences for non-metastatic castration-resistant prostate cancer treatment. Srinivas, S., Mohamed, AF., Appukkuttan, S., et al.[2021]

The Personal Patient Profile-Prostate (P3P) intervention did not significantly improve the alignment between men's treatment choices for localized prostate cancer and their concerns about side effects, with concordance rates of 45% for the P3P group and 50% for the control group.

Despite the P3P's focus on personal preferences, the study suggests that immediate information and physician consultations after diagnosis may have a stronger influence on treatment decisions than the decision aid itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. Bosco, JL., Halpenny, B., Berry, DL.[2022]

The CaP Calculator is a new online tool designed to help doctors and patients make informed treatment decisions for localized prostate cancer by providing personalized risk assessments based on clinical data like T stage, Gleason score, and PSA levels.

This tool aggregates multiple predictive models to estimate disease extent and treatment outcomes, aiming to reduce patient distress and decisional regret by facilitating shared decision-making between clinicians and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 'CaP Calculator': an online decision support tool for clinically localized prostate cancer. Katz, MS., Efstathiou, JA., D'Amico, AV., et al.[2021]

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]

An interactive decision aid (DA) for men with localized prostate cancer was developed and positively received by participants, who found it helpful for understanding treatment options and side effects, indicating its potential efficacy in aiding decision-making.

The DA was well-received in a survey of 11 newly diagnosed patients, with all participants recommending it, and it is currently being tested in a randomized clinical trial to evaluate its effectiveness compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Adaptation, Extension and Pre-Testing of an Interactive Decision Aid for Men Diagnosed with Localized Prostate Cancer in Iceland: A Mixed-Method Study. Eiriksdottir, VK., Jonsdottir, T., Valdimarsdottir, HB., et al.[2023]

A systematic review identified 10 interactive decision aids for nonmetastatic prostate cancer, with 6 having scientific evaluations, which help patients understand their treatment options better.

Using these decision aids increased patients' disease-related knowledge and confidence in their treatment choices, indicating their effectiveness in supporting shared decision-making between patients and physicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of nonmetastatic prostate cancer: a systematic review of interactive, personalized patient decision aids]. Groeben, C., Streuli, JC., Krones, T., et al.[2021]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Decision preparation, satisfaction and regret in a multi-center sample of men with newly diagnosed localized prostate cancer. [2022]

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

Decision support for men with prostate cancer: Concordance between treatment choice and tumor risk. [2022]

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

Integrating Patient Preference into Treatment Decisions for Men with Prostate Cancer at the Point of Care. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Usability evaluation and adaptation of the e-health Personal Patient Profile-Prostate decision aid for Spanish-speaking Latino men. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Actual use and perceived usefulness of a web-based, decision support program for men with prostate cancer. [2015]

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

Patient and caregiver benefit-risk preferences for nonmetastatic castration-resistant prostate cancer treatment. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer. [2022]

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

Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15). [2019]

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

Physician preferences for non-metastatic castration-resistant prostate cancer treatment. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Personal preferences and discordant prostate cancer treatment choice in an intervention trial of men newly diagnosed with localized prostate cancer. [2022]

11. England pubmed.ncbi.nlm.nih.gov

The 'CaP Calculator': an online decision support tool for clinically localized prostate cancer. [2021]

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

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

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

An Adaptation, Extension and Pre-Testing of an Interactive Decision Aid for Men Diagnosed with Localized Prostate Cancer in Iceland: A Mixed-Method Study. [2023]

14. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of nonmetastatic prostate cancer: a systematic review of interactive, personalized patient decision aids]. [2021]