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

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT03103321
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 158
• Locations: 28
• Arms: 4
• Actual Duration (Months): 40.4
• Patients Per Site: 5.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stage II Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage I Prostate Cancer; PSA Level Five to Ten; PSA Level Less Than Five; PSA Level Ten to Fifty	Other: Internet-Based Intervention; Other: Internet-Based Intervention; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Survey Administration; Other: Laboratory Biomarker Analysis	Phase 3

Detailed Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

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

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

3. 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.

4. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Testing Decision Aids to Improve Prostate Cancer Decisions for Minority Men
• Actual Study Start Date: Jul 14, 2017
• Actual Primary Completion Date: Dec 5, 2019
• Actual Study Completion Date: Nov 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A ("Knowing your Options", "Prostate Choice") Patients receive decision aids "Knowing your Options" before and "Prostate Choice" during their consultation visit.	Other: Internet-Based Intervention; Receive "Knowing your Options" decision aid; Other: Internet-Based Intervention; Receive "Prostate Choice" decision aid; Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies
Experimental: Arm B ("Knowing your Options") Patients receive "Knowing your Options" decision aid before their consultation visit.	Other: Internet-Based Intervention; Receive "Knowing your Options" decision aid; Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies
Experimental: Arm C ("Prostate Choice") Patients receive "Prostate Choice" decision aid during their consultation visit.	Other: Internet-Based Intervention; Receive "Prostate Choice" decision aid; Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies
Active Comparator: Arm D (usual care) Patients undergo usual care.	Other: Best Practice; Undergo usual care; Other Names: standard of care standard therapy ; Other: Quality-of-Life Assessment; Ancillary studies; Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; Other: Laboratory Biomarker Analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente-Bellflower	Bellflower	California	United States	90706
2	Kaiser Permanente-Cadillac	Los Angeles	California	United States	90034
3	Kaiser Permanente Oakland-Broadway	Oakland	California	United States	94611
4	Augusta University Medical Center	Augusta	Georgia	United States	30912
5	Tripler Army Medical Center	Honolulu	Hawaii	United States	96859
6	John H Stroger Jr Hospital of Cook County	Chicago	Illinois	United States	60612
7	Ochsner Health Center-Summa	Baton Rouge	Louisiana	United States	70809
8	Ochsner Medical Center Jefferson	New Orleans	Louisiana	United States	70121
9	Louisiana State University Health Sciences Center Shreveport	Shreveport	Louisiana	United States	71103
10	William Beaumont Hospital-Royal Oak	Royal Oak	Michigan	United States	48073
11	University of New Mexico Cancer Center	Albuquerque	New Mexico	United States	87102
12	Montefiore Medical Center-Einstein Campus	Bronx	New York	United States	10461
13	Montefiore Medical Center-Weiler Hospital	Bronx	New York	United States	10461
14	Montefiore Medical Center - Moses Campus	Bronx	New York	United States	10467
15	James J Peters VA Medical Center	Bronx	New York	United States	10468
16	Northwell Health/Center for Advanced Medicine	Lake Success	New York	United States	11042
17	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York	United States	10032
18	Medical University of South Carolina	Charleston	South Carolina	United States	29425
19	Prisma Health Cancer Institute - Laurens	Clinton	South Carolina	United States	29325
20	Prisma Health Cancer Institute - Easley	Easley	South Carolina	United States	29640
21	Prisma Health Cancer Institute - Butternut	Greenville	South Carolina	United States	29605
22	Prisma Health Cancer Institute - Faris	Greenville	South Carolina	United States	29605
23	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
24	Prisma Health Cancer Institute - Eastside	Greenville	South Carolina	United States	29615
25	Prisma Health Cancer Institute - Greer	Greer	South Carolina	United States	29650
26	Prisma Health Cancer Institute - Seneca	Seneca	South Carolina	United States	29672
27	Prisma Health Cancer Institute - Spartanburg	Spartanburg	South Carolina	United States	29307
28	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia	United States	23298

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: [e-mail] [e-mail], MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 30, 2018

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT03103321
• Other Study ID Numbers: A191402CD; NCI-2017-00482
• First Posted: Apr 6, 2017
• Last Update Posted: Jan 13, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

Participant Flow

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Period Title: Overall Study
STARTED	25	39	44	50
COMPLETED	24	38	43	50
NOT COMPLETED	1	1	1	0

Baseline Characteristics

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care	Total
Arm/Group Description	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	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	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	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	Total of all reporting groups
Overall Participants	25	39	44	50	158
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.5 (7.33)	63.1 (8.09)	64.6 (7.46)	63.4 (7.87)	63.5 (7.69)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	25 100%	39 100%	44 100%	50 100%	158 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 2.6%	2 4.5%	0 0%	3 1.9%
Not Hispanic or Latino	25 100%	37 94.9%	38 86.4%	47 94%	147 93%
Unknown or Not Reported	0 0%	1 2.6%	4 9.1%	3 6%	8 5.1%

Outcome Measures

1. Primary Outcome

Title	Knowledge Assessed by Prostate Cancer Treatment Questionnaire
Description	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
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Measure Participants	24	38	43	50
Mean (Standard Deviation) [percentage of items correct]	0.69 (0.165)	0.65 (0.164)	0.58 (0.167)	0.56 (0.232)

2. Secondary Outcome

Title	Decisional Quality as Measured by Decisional Conflict Scale Decisional Regret
Description	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).
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Measure Participants	24	38	43	50
DCS Total Score of 0	13 52%	15 38.5%	25 56.8%	30 60%
DCS Total Score of 1+	11 44%	23 59%	18 40.9%	20 40%

3. Secondary Outcome

Title	Clinical Time Required
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Measure Participants	25	39	32	50
Median (Full Range) [Minutes]	27	38	52.5	39.5

4. Secondary Outcome

Title	Quality of Life Assessed by Questionnaire
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Measure Participants	25	39	44	50
Urinary Irritative	90.63	93.75	90.63	87.5
Urinary Incontinence	96.88	85.5	85.5	93.75
Bowel	100	100	100	100
Sexual	33.33	36.17	95	90
Hormonal	92.5	95	95	90

5. Secondary Outcome

Title	Utilization as Determined by Chart Review
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Only includes eligible patients that reached 12 months.

Arm/Group Title	Pre- and During-consultation Decision Aids	Pre-consultation Decision Aids Only	During-consultation Decision Aids Only	Usual Care
Arm/Group Description	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	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	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	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
Measure Participants	16	38	44	50
Active surveillance	4 16%	9 23.1%	15 34.1%	16 32%
Surgery (without radiation)	6 24%	17 43.6%	7 15.9%	12 24%
Radiation (without surgery)	5 20%	5 12.8%	10 22.7%	18 36%
Radiation + Surgery	0 0%	0 0%	0 0%	2 4%
Treatment Choice Not Listed	0 0%	2 5.1%	6 13.6%	0 0%
No Treatment (patients that submitted a month 12 form and said No to receiving treatment)	1 4%	5 12.8%	6 13.6%	2 4%

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	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/Group Title	Pre- and During-consultation Decision Aids		Pre-consultation Decision Aids Only		During-consultation Decision Aids Only		Usual Care
Arm/Group Description	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		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		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		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
All Cause Mortality
	Pre- and During-consultation Decision Aids		Pre-consultation Decision Aids Only		During-consultation Decision Aids Only		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		1/38 (2.6%)		1/43 (2.3%)		0/50 (0%)
Serious Adverse Events
	Pre- and During-consultation Decision Aids		Pre-consultation Decision Aids Only		During-consultation Decision Aids Only		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Pre- and During-consultation Decision Aids		Pre-consultation Decision Aids Only		During-consultation Decision Aids Only		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.