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

Phase 3

Completed

Conditions: Stage IIA Prostate Cancer
PSA Level Ten to Fifty
PSA Level Five to Ten
Stage II Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage I Prostate Cancer
PSA Level Less Than Five

Registration Number: NCT03103321

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 158

Inclusion Criteria

Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
Prostate-specific antigen (PSA) < 50 ng/mL
Patients who have had a history of non-cutaneous malignancy in the previous 5 years are not eligible; exception: patients with history of non-melanoma skin cancer are eligible
Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
Patients may not be concurrently enrolled to another clinical trial for the treatment of cancer; co-enrollment to biospecimen studies is allowed
Patients with impaired decision-making capacity (such as with a diagnosis of dementia or memory loss) are not eligible for this study
Patients must be able to read and comprehend English; non-English-speaking patients may participate so long as an interpreter (e.g., family member, clinic staff, etc.) is present for consent, for the decision aid administration, and gathering of baseline and follow-up measures

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Knowledge Assessed by Prostate Cancer Treatment Questionnaire	12 months	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

Secondary Outcome Measures

Name	Time	Method
Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret	12 months	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).
Utilization as Determined by Chart Review	12 months	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.
Clinical Time Required	12 months	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.
Quality of Life Assessed by Questionnaire	12 months	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.

Trial Locations

Locations (28): Kaiser Permanente-Bellflower
🇺🇸
Bellflower, California, United States
Kaiser Permanente-Cadillac
🇺🇸
Los Angeles, California, United States
Kaiser Permanente Oakland-Broadway
🇺🇸
Oakland, California, United States
Augusta University Medical Center
🇺🇸
Augusta, Georgia, United States
Tripler Army Medical Center
🇺🇸
Honolulu, Hawaii, United States
John H Stroger Jr Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
Ochsner Health Center-Summa
🇺🇸
Baton Rouge, Louisiana, United States
Ochsner Medical Center Jefferson
🇺🇸
New Orleans, Louisiana, United States
Louisiana State University Health Sciences Center Shreveport
🇺🇸
Shreveport, Louisiana, United States
William Beaumont Hospital-Royal Oak
🇺🇸
Royal Oak, Michigan, United States
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Kaiser Permanente-Bellflower
🇺🇸Bellflower, California, United States