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

Arm A ("Knowing your Options") 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

Jon C. Tilburt, M.D.

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

Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men

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 proportion of total number correct. With 1.0 (12 out of 12 item average) being the best possible outcome and 0.0 (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 continuous scores were then grouped into two categories, 0 (no regret) and 1+ (at least some regret).

The Expanded Prostate Cancer Index Composit (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 represented 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 elected to receive. Will be compared across intervention arms.

National Institute on Minority Health and Health Disparities (NIMHD)

Mayo Clinic

Principal Investigator

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.

Arm A ("Knowing your Options") 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

Arm A (Knowing Your Options)

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

Arm B (Prostate Choice)

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

Arm C (Usual Care)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Treatment Preferred

Dr. Jon C. Tilburt, MD, MPH

Knowledge Assessed by Prostate Cancer Treatment Questionnaire

Secondary outcomes were to be based on data collected at 12 months. Two of our sites (enrolling \>50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with nearly all participants at both sites and were unable to collect secondary outcome data at 12 months. Results reported here reflect the data we were able to collect.

Decisional Quality as Measured by Decisional Regret Scale

Urinary Incontinence

Urinary Irritative

Bowel

Sexual

Hormonal

Quality of Life Assessed by Questionnaire

Radical prostatectomy

Laparoscopic radical prostatectomy

Robotic-assisted laparoscopic radical prostatectomy

Cryosurgery

Intensity modulated radiation therapy (IMRT)

Brachytherapy

Proton beam

Hormone therapy

Chemotherapy

Active surveillance

Secondary outcomes were to be based on data collected at 12 months. Treatment choice could be ascertained immediately upon patient treatment selection. Two of our sites (enrolling \>50% of study participants) experienced staff turnover and/or loss of contact with participants. As a result, we lost our ability and opportunity to maintain contact with several participants and were unable to collect treatment choice for all participants. Results reported reflect the data we were able to collect.

Spots Global Cancer Trial Database for Decision Aids to Improve Knowledge in Patients With Prostate Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial