Decision-Making Support for Prostate Cancer Screening

(PSA Trial)

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Non-Latino, Age, Prostate problems, others

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

Compensation: Varies

Number of Visits: 2

1006 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this intervention trial is aiming to increase inform decision- making in Latino men regarding prostate cancer screening. The investigators propose to find out how much Latino men know about the benefits and risks of prostate cancer screening and what factors influence how they decide whether or not to have screening. The investigators are also interested in learning how providing education information, both verbally and in print, about the risks and benefits of prostate cancer screening affects men's interest and knowledge. The intervention is an interactive multi-media presentation made up of a small group of 8-10 Latino men gathered to discuss about prostate cancer, screening methods, treatment, and the controversy within the medical community regarding PSA screening. A facilitator guides the 1-hour discussion and encourages participant interaction. The effect of this intervention was tested on 1000 Latino men within Los Angeles county. Participants were recruited from 38 community venues (churches, community center, etc.). All participants were interviewed before being randomized to receive written (control group) or oral (intervention) prostate cancer education material. All of the participants will be followed up at 6-months via a telephone interview. The investigators hypothesize that the intervention group will have an increase knowledge of prostate cancer, will have increase communication with family, friends, and medical provider, and will have an increase rate of PSA screening compared to the control group.

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 treatment Intervention Session, Printed Material for prostate cancer screening?

Research shows that decision aids, like printed materials and intervention sessions, can help patients make more informed decisions about prostate cancer screening by reducing confusion and increasing knowledge about the screening process. ^{1 2 3 4 5}

Is the decision-making support for prostate cancer screening safe?

The research articles focus on improving decision-making for prostate cancer screening and do not report any safety concerns related to the decision aids or materials used in these studies. ^{1 6 7 8 9}

How is the Decision-Making Support treatment for prostate cancer screening different from other treatments?

The Decision-Making Support treatment for prostate cancer screening is unique because it focuses on helping patients make informed decisions about screening through decision aids and shared decision-making approaches, rather than directly treating the cancer itself. This approach emphasizes aligning screening decisions with a man's personal values and preferences, which is different from traditional medical treatments that focus on physical interventions. ^{1 2 5 10 11}

Research Team

Roshan Bastani, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for Latino men aged 50-70 in Los Angeles who have never had prostate cancer or a PSA test in the last year, and do not currently have prostate issues like pain during urination. Men with previous prostate surgery, biopsy, or outside the age range are excluded.

Inclusion Criteria

I am a Latino man.

I do not have prostate inflammation.

I have never had prostate cancer.

Exclusion Criteria

Having had a prostate biopsy

I am either under 50 or over 70 years old.

Living outside of Los Angeles county

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in an interactive multi-media presentation discussing prostate cancer, screening methods, and treatment. A facilitator guides the 1-hour discussion.

1 hour

1 visit (in-person)

Follow-up

Participants are followed up at 6 months via a telephone interview to assess knowledge and communication about prostate cancer.

6 months

1 visit (telephone)

Treatment Details

Interventions

• Intervention Session
• Printed Material

Trial Overview The study tests if an interactive session discussing prostate cancer screening can improve decision-making among participants compared to just receiving printed material. The impact on knowledge and screening rates will be assessed through follow-ups.

Participant Groups

Group I: 2 Experimental Treatment 1 Intervention

Printed material regarding general prostate cancer information provided.

Group II: 1 Experimental Treatment 1 Intervention

Educational small group session regarding prostate cancer

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

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

A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. [2021]

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

A randomized controlled trial of shared decision making for prostate cancer screening. [2021]

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

Patient education on prostate cancer screening and involvement in decision making. [2022]

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

Uptake and usage of an online prostate cancer treatment decision aid in Dutch clinical practice: A quantitative analysis from the Prostate Cancer Patient Centered Care trial. [2020]

5. Scotland pubmed.ncbi.nlm.nih.gov

Efficacy of a decision support intervention for reducing decisional conflict in patients with elevated serum prostate-specific antigen: A randomized controlled trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Does evidence-based information about screening for prostate cancer enhance consumer decision-making? A randomised controlled trial. [2021]

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

A decision aid versus shared decision making for prostate cancer screening: results of a randomized, controlled trial. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Communication, perception, and use of personalized side-effect risks in prostate cancer treatment-decision making: An observational and interview study. [2022]

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

Internet patient decision support: a randomized controlled trial comparing alternative approaches for men considering prostate cancer screening. [2021]

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

Decision making and prostate cancer screening. [2014]

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

Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam. [2021]