Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

Patients receive "Knowing your Options" decision aid before their consultation visit.

Patients receive "Prostate Choice" decision aid during their consultation visit.

Receive "Knowing your Options" decision aid

Internet-Based Intervention

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Survey Administration

Laboratory Biomarker Analysis

tilburt.jon@mayo.edu tilburt.jon@mayo.edu, MD

This randomized phase III trial studies how well decision aids work in improving knowledge in patients with newly diagnosed prostate cancer. Decision aids may improve patients' knowledge of their condition and options for treatment, and may also help when talking with their doctor.

PRIMARY OBJECTIVES:

I. To test the comparative effectiveness of decision aids (DA's) on patient knowledge.

SECONDARY OBJECTIVES:

I. To test the impact of in-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

II. To test the impact of out-of-visit DA's alone compared to usual care on quality of life outcomes and treatment utilization.

III. To test the impact of combined in-visit and out-of-visit DA's compared to both usual care and individual DAs on quality of life outcomes and treatment utilization.

IV. To test the comparative effectiveness of DA's on minority men's knowledge. V. To compare clinic time required to administer the DA's across arms.

OUTLINE: Patients are randomized into 1 of 4 arms.

ARM A: Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

ARM B: Patients receive "Knowing your Options" decision aid before their consultation visit.

ARM C: Patients receive "Prostate Choice" decision aid during their consultation visit.

ARM D: Patients undergo usual care.

After completion of study, patients are followed up at 12 months.

Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer

Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

IPD that underlie results in the publication PubMed ID 34890060.

The primary outcome, knowledge, will be assessed by a standardized questionnaire (i.e., Prostate Cancer Treatment Questionnaire) administered once, immediately after the clinical consultation while the patient is still at the study site. The number correct from this 12-item measure will be reduced to a percentage of total number correct. With 100%(12 out of 12 item average) being the best possible outcome and 0%(0 out of 12 item average) the worst possible outcome

The Decisional Regret Scale is a short, 5-item scale measuring "distress or remorse after a (health care) decision." The instrument has been validated in other decision aid studies. Questions are answered on a 5-point agreement scale. A score of 0 means no decisional regret and 5 is the maximum level of regret. The median scores for each cohort were grouped into two categories, 0(no regret) and 1+(at least some regret).

Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

The Expanded Prostate Cancer Index Composite(EPIC-26) measures health-related quality of life and returns summary scores for urinary, bowel, sexual, and hormonal domains with high test-retest reliability and internal consistency. Scores will be converted into continuous summary scores using standard algorithms. For the EPIC-26 questionnaire, scores were transformed into 0 to 100 scales, with a score of 0 representing the worst possible health-related quality of life and a score of 100 representing the most favorable health-related quality of life. The questionnaire will be administered once; 12 months after the patient's initial consultation.

Will be categorized by the type of treatment the patient received. Will be compared across DA types using linear mixed models. In particular, this model will include fixed effects for Prostate Choice and Knowing Your Options and a random, site-specific intercept to allow for subjects within the same site to be correlated. Will explore whether the overall effects of interventions on patient knowledge, quality of life, and treatment utilization differ by racial/ethnic subgroups.

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

This study did not collect adverse events.

We do not anticipate any additional adverse events related to participation in this study beyond usual care. If patients experience any emotional discomfort when completing the questionnaires, they may choose not to complete them and/or speak with the site staff. Patients experiencing any physical or psychological complications related to their standard of care treatment should discuss this with their treating physician.

Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.

Internet-Based Intervention: Receive "Knowing your Options" decision aid

Internet-Based Intervention: Receive "Prostate Choice" decision aid

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Survey Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Pre- and During-consultation Decision Aids

Patients receive "Knowing your Options" decision aid before their consultation visit.

Internet-Based Intervention: Receive "Knowing your Options" decision aid

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Survey Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Pre-consultation Decision Aids Only

Patients receive "Prostate Choice" decision aid during their consultation visit.

Internet-Based Intervention: Receive "Prostate Choice" decision aid

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Survey Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

During-consultation Decision Aids Only

Patients undergo usual care.

Best Practice: Undergo usual care

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Survey Administration: Ancillary studies

Laboratory Biomarker Analysis: Correlative studies

Spots Global Cancer Trial Database for psa level less than five