Trial Outcomes & Findings for Testing the Helpfulness of 2 Decision Aids for Prostate Cancer (NCT NCT00432601)

Results Overview

Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1028 participants

Primary outcome timeframe

Results visit (Time 2 - approximately 7-10 days after Time 1)

Results posted on

2016-03-22

Participant milestones
Measure	Arm 1 - MCC Patients will receive Michigan Cancer Consortium decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.	Arm 2 - NCCN Patients will receive National Comprehensive Cancer Network decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
Time 1 to Time 2 STARTED	510	512
Time 1 to Time 2 COMPLETED	141	144
Time 1 to Time 2 NOT COMPLETED	369	368
Time 2 to Time 3 STARTED	141	144
Time 2 to Time 3 COMPLETED	122	122
Time 2 to Time 3 NOT COMPLETED	19	22

Withdrawal data not reported

Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

Baseline characteristics by cohort
Measure	Arm 1 n=510 Participants Patients will receive Michigan Cancer Consortium decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.	Arm 2 n=512 Participants Patients will receive National Comprehensive Cancer Network decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.	Total n=1022 Participants Total of all reporting groups
Age, Continuous	63.41 years STANDARD_DEVIATION 5.86 • n=99 Participants	63.14 years STANDARD_DEVIATION 6.02 • n=107 Participants	63.28 years STANDARD_DEVIATION 5.94 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	510 Participants n=99 Participants	512 Participants n=107 Participants	1022 Participants n=206 Participants

Timeframe: Results visit (Time 2 - approximately 7-10 days after Time 1)

Questions addressed the survival benefit and side effects associated with treatment options for localized prostate cancer.

Outcome measures
Measure	Arm 1 - MCC n=139 Participants Patients will receive Michigan Cancer Consortium decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.	Arm 2 - NCCN n=140 Participants Patients will receive National Comprehensive Cancer Network decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
Knowledge	53 percentage correct on a 12 item scale Standard Error .03	48 percentage correct on a 12 item scale Standard Error .03

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Arm 1 - MCC n=510 participants at risk Patients will receive Michigan Cancer Consortium decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.	Arm 2 - NCCN n=512 participants at risk Patients will receive National Comprehensive Cancer Network decision aid. type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication.
Nervous system disorders Seizure	0.20% 1/510 1 adverse event occurred prior to randomization to a study arm. A participant fainted while in the process of completing a paper survey. The adverse event was reported to our IRB who determined that it was not related to the research protocol.	0.00% 0/512 1 adverse event occurred prior to randomization to a study arm. A participant fainted while in the process of completing a paper survey. The adverse event was reported to our IRB who determined that it was not related to the research protocol.

VA HSRD

Phone: 801-587-1694