Support and Intervention for Latiné Prostate Cancer Survivors

Overseen By Christophar Weight, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Non-English/Spanish speakers, Brachytherapy, Radiation, others

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

Compensation: Varies

Number of Visits: 3

288 Participants Needed

Trial Summary

What is the purpose of this trial?

Prostate cancer is a significant concern for Latiné men, with over 17,000 new cases annually. Decision-making for treatment is complex, especially due to barriers like low health literacy and cultural factors. Research on survivorship and post-treatment issues like erectile dysfunction is lacking. To improve care, a study will engage 288 participants across various medical facilities, including 100 at Cleveland Clinic. Thirty subjects will participate in focus groups representing Spanish-speaking Latiné, bilingual Latiné, and English-speaking non-Latiné individuals to understand their perspectives and enhance communication. This aims to develop tailored resources, like Spanish-language educational videos, addressing language and cultural needs for informed decision-making.

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 data supports the effectiveness of the treatment Expanded Prostate Cancer Index Composite and Decision Regret Scale for Latiné Prostate Cancer Survivors?

The research suggests that using decision support tools can reduce decisional conflict and regret in prostate cancer patients, which may imply that the Expanded Prostate Cancer Index Composite and Decision Regret Scale could help Latiné prostate cancer survivors feel more satisfied with their treatment decisions. ^{1 2 3 4 5}

How does the treatment for Latiné prostate cancer survivors differ from other treatments?

The treatment for Latiné prostate cancer survivors is unique because it focuses on support and intervention, which may help reduce treatment decision regret and improve quality of life, unlike traditional treatments that primarily focus on medical procedures like surgery or radiation. ^{1 3 4 6 7}

Research Team

Christopher Weight, MD

Principal Investigator

Cleveland Clinic Glickman Urological and Kidney Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for Spanish-speaking Latiné men who have survived prostate cancer. It aims to understand their unique challenges in post-treatment issues and decision-making, considering cultural and language barriers.

Inclusion Criteria

I have been diagnosed with prostate cancer that has not spread.

I am over 18 years old.

Subjects must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria

My primary language is neither English nor Spanish.

My first treatment for cancer was radiation or brachytherapy.

My cancer is getting worse and I need treatments like hormone therapy, chemotherapy, or immunotherapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group Sessions

Participants engage in focus group sessions to discuss cultural nuances in survivorship decision making

3 sessions of 90 minutes each

3 visits (in-person)

Follow-up

Participants are monitored for quality of life outcomes related to urinary, bowel, sexual, and hormonal health post radical prostatectomy

4 weeks

Treatment Details

Interventions

• Expanded Prostate Cancer Index Composite and Decision Regret Scale

Trial Overview The study tests the effectiveness of tailored resources like educational videos in Spanish. It involves surveys (Expanded Prostate Cancer Index Composite) and scales (Decision Regret Scale) to measure outcomes.

Participant Groups

Group I: Prostate cancer treatment outcomes Experimental Treatment 1 Intervention

The study population will be divided into three cohorts: * Spanish-speaking preferred Latiné, * English-speaking preferred Latiné, * English-speaking non-Latiné patients. Domain assessments between groups will be made using ANOVA with pairwise comparisons.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Findings from Research

In a study of 652 prostate cancer patients treated with various methods (radical prostatectomy, external beam radiation therapy, brachytherapy, or active surveillance), decisional regret was generally low across all treatment options, indicating that patients felt satisfied with their choices.

The only significant factor associated with higher levels of regret was being African American, suggesting that this demographic may experience different emotional responses post-treatment, while declines in health-related quality of life had only a weak correlation with regret.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal regret after treatment for low- and intermediate-risk prostate cancer. Hurwitz, LM., Cullen, J., Kim, DJ., et al.[2022]

The Personal Patient Profile-Prostate decision support tool did not significantly reduce decision regret overall, but it was particularly effective in lowering regret among Black men diagnosed with localized prostate cancer, suggesting a tailored benefit for this group.

Factors such as hormonal and bowel symptoms were linked to higher decision regret, indicating that the type of treatment chosen and individual health conditions can influence patients' emotional responses to their treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial. Berry, DL., Hong, F., Blonquist, TM., et al.[2022]

In a study of 484 men with recurrent prostate cancer, black men reported significantly higher rates of treatment regret compared to non-black men, with 21.8% versus 12.6% experiencing regret, respectively.

The study found that among men without sexual problems post-treatment, black men had a much higher rate of treatment regret (26.7%) compared to non-black men (8.4%), indicating that sexual health issues may influence the perception of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between race and treatment regret among men with recurrent prostate cancer. Mahal, BA., Chen, MH., Bennett, CL., et al.[2022]

In a study of 1003 long-term prostate cancer survivors, decision regret increased from 9.0% to 12% over approximately 13 years, indicating that many patients continue to feel regret about their treatment choices long after surgery.

Factors such as having favorable localized cancer, previous decision regret, and higher depression scores were linked to increased regret, while involving patients in shared decision-making significantly reduced the likelihood of regret.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment decision regret in long-term survivors after radical prostatectomy: a longitudinal study. Meissner, VH., Simson, BW., Dinkel, A., et al.[2023]

Decisional conflict among patients with localized prostate cancer significantly decreased over six months post-treatment, indicating improved satisfaction with their treatment decisions.

Despite the overall improvement, many patients still felt less informed about their treatment options, particularly those with lower education levels or passive decision-making preferences, highlighting the need for better information and support from healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in decisional conflict and decisional regret in patients with localised prostate cancer. Chien, CH., Chuang, CK., Liu, KL., et al.[2022]

In a survey of 201 men with metastatic prostate cancer, 23% expressed regret over their treatment decisions, with regret more common among those who chose surgical castration compared to chemical castration.

Regret was linked to poorer quality of life scores and was associated with recent complications like nausea, highlighting the importance of effective communication and support during treatment decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer. Clark, JA., Wray, NP., Ashton, CM.[2017]

In a study of 793 prostate cancer patients, decisional regret was found to increase significantly from 6 to 12 months post-diagnosis, particularly among those who underwent prostatectomy, indicating that treatment choice can impact emotional well-being over time.

The study revealed that higher levels of regret were associated with greater activity limitations and distress related to urinary and sexual dysfunction, suggesting that discussions about quality of life should be integral to treatment counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regret of treatment decision and its association with disease-specific quality of life following prostate cancer treatment. Diefenbach, MA., Mohamed, NE.[2022]

References

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

Longitudinal regret after treatment for low- and intermediate-risk prostate cancer. [2022]

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

Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The association between race and treatment regret among men with recurrent prostate cancer. [2022]

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

Treatment decision regret in long-term survivors after radical prostatectomy: a longitudinal study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Changes in decisional conflict and decisional regret in patients with localised prostate cancer. [2022]

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

Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer. [2017]

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

Regret of treatment decision and its association with disease-specific quality of life following prostate cancer treatment. [2022]