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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care and resources for Latiné men who have survived prostate cancer, focusing on issues like erectile dysfunction and treatment decision-making. Participants will share their experiences to help create educational materials, such as Spanish-language videos, to aid informed choices. The trial targets those who have had localized prostate cancer, undergone prostate removal surgery, and can communicate in English or Spanish. Participants will be grouped by language preference and cultural background to assess different outcomes. The Expanded Prostate Cancer Index Composite and Decision Regret Scale will evaluate the interventions' effectiveness. As an unphased trial, this study offers a unique opportunity to contribute to developing resources that can significantly enhance patient care and 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 prior data suggests that this study's methods are safe?

Research has shown that the Expanded Prostate Cancer Index Composite reliably measures the quality of life in prostate cancer patients. It consistently captures various aspects of prostate cancer care, indicating ease of use for patients in studies.

The Decision Regret Scale, also used in this trial, measures patients' feelings about their treatment decisions afterward. Although not a treatment, research has shown it to be safe and simple for patients to use.

Both tools gather information without posing any physical risks. They are designed to enhance understanding of patient experiences. Participants can feel confident using them in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving quality of life and decision-making for Latiné prostate cancer survivors. Unlike traditional treatments that primarily address the cancer itself, this approach uses tools like the Expanded Prostate Cancer Index Composite and Decision Regret Scale to evaluate and enhance patient experiences and satisfaction post-treatment. By examining outcomes across different language preferences and cultural backgrounds, the trial aims to provide personalized insights that could lead to more tailored and effective support systems for diverse patient groups.

What evidence suggests that this trial's treatments could be effective for prostate cancer survivors?

This trial will assess prostate cancer treatment outcomes among three cohorts: Spanish-speaking preferred Latiné, English-speaking preferred Latiné, and English-speaking non-Latiné patients. Research has shown that choosing a treatment for prostate cancer can sometimes lead to regret. One study found that about 14.6% of men felt significant regret after their treatment, with those who chose less aggressive treatments feeling less regret. Another study revealed that 78% of men completed surveys about their treatment choices, highlighting the need to understand these decisions. The EPIC-26 questionnaire measures how prostate cancer treatments affect a patient's quality of life. This tool helps identify the impact of treatments on health and can lead to better decision-making. Understanding these outcomes is key to improving care and reducing regret among prostate cancer survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

Christopher Weight, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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

I am over 18 years old.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5501361/

Treatment Decision Regret Among Long-Term Survivors of ... Treatment decision regret (score ≥ 40) was expressed by 14.6% of men, with significant variation ranging from 8.2% of men who received conservative treatment to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1078143920306256

Clinical-Prostate cancer Decision regret, adverse ... At 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered ...

3. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2786406

Treatment-Related Regret Among Men With Prostate Cancer These findings suggest that treatment-related regret is common among patients with localized prostate cancer, and rates appear to differ among treatment ...

4. researchgate.net researchgate.net/publication/281622586_Expanded_prostate_cancer_index_composite_EPIC-26_Results_of_functional_treatment_in_patients_with_localized_prostate_cancer

"Expanded prostate cancer index composite" (EPIC-26) ... CERTs had a statistically significant higher annual caseload, with a median of 125 vs. 29 radical prostatectomies performed per year during ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21788038/

Expanded prostate cancer index composite for clinical practice Results: A total of 175 treated and 132 untreated subjects with prostate cancer completed the Expanded Prostate Cancer Index Composite for Clinical Practice.

6. auajournals.org auajournals.org/doi/abs/10.1016/j.juro.2011.04.085

Expanded Prostate Cancer Index Composite for Clinical ... The Expanded Prostate Cancer Index Composite for Clinical Practice is a valid instrument that enables patient reported, health related quality ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090429514009893

Minimally Important Difference for the Expanded Prostate ... Objective. To establish a score threshold that constitutes a clinically relevant change for each domain of the Expanded Prostate Cancer Index Composite (EPIC) ...

8. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/10.1002/bco2.476

Treatment decision regret after precision prostatectomy: An ... This study aimed to assess postoperative decision regret (DR) after precision prostatectomy (PP), a novel subtotal surgical technique for prostate cancer (PCa)