Testing the Helpfulness of 2 Decision Aids for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432601
• Other study ID #: IIR 05-283
• Status: Completed
• Phase: N/A
• First received: February 6, 2007
• Last updated: November 13, 2014
• Start date: August 2008
• Est. completion date: September 2012

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test different methods for communicating information about prostate cancer treatment to men. The investigators are studying how best to present information so men can make informed decisions about what prostate cancer treatment to undergo.

Description:

Background/Rationale: Prostate cancer is the second leading cause of cancer related death among men in the United States, and accounts for 29% of all cancers diagnosed in men. Furthermore, approximately one in six men will be diagnosed with prostate cancer in their lifetime. Thus, 17% of male Veterans will be asked to make a decision about the treatment of their prostate cancer. The burden of this disease is further magnified when one considers that most patients will live for years following their diagnosis and with any adverse effects of therapy. Given that there have been no clinical trials showing that any prostate cancer treatment produces an increased likelihood of survival; men are asked to actively participate in treatment decisions. Previous research has revealed that men are often uninformed about their prostate cancer, particularly African American men and men with lower educational attainment. Thus, it is critical to develop and test decision aids that can help all men (especially men with low literacy skills) make an informed decision.

Objective(s): The goal of the study is to compare the impact of a plain language decision aid (DA) to a conventional DA on prostate cancer patients' decision making experience and communication with their physician.

Methods: This study is a randomized controlled trial. Men undergoing a prostate biopsy will be recruited at the time of biopsy and complete a baseline interview (at pre-biopsy or biopsy appointment). Those patients diagnosed with localized prostate cancer will complete two additional interviews: at physician visit (diagnosis), and 7-10 days following physician visit (phone survey). The treatment discussion between patients and their physician will be audio recorded.

Major characteristics: All men, without a prior history of prostate cancer, undergoing a prostate biopsy will be screened for eligibility and enrolled by the study coordinator. Additional inclusion criteria include ability to speak English, provide informed consent, and have a PSA < 20. Physicians can refuse to allow a patient participate in the study at the time of biopsy. Men will be recruited from 4 VA hospitals (Ann Arbor, Durham, Pittsburgh, and San Francisco) and randomized to receive one of two decision aid booklets (plain language vs. conventional).

Major variables and source(s) of data: All survey data will be collected from either face-to-face or phone interviews. The surveys include measures of literacy, numeracy, anxiety, preference for shared decision making, knowledge, treatment preferences, risk perceptions, perception of patient-physician communication, and confidence and satisfaction with the decision making process. All survey questions were read aloud and responses recorded.

Status: Recruitment began in September 2008 and concluded in May of 2012.

1552 men were approached to participate in the study with 1028 agreeing. 1023 completed the Time 1 interview. Of the 334 subjects eligible to continue with study activities, 285 subjects completed the Time 2 interview (biopsy results visit), and 244 completed the Time 3 phone interview.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1028
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Men undergoing a prostate cancer biopsy at Ann Arbor, Durham, San Francisco, or Pittsburgh VAs. Additional inclusion criteria includes ability to speak English, provide informed consent, and have a PSA < 20.

Exclusion Criteria:

Prior history of prostate cancer

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System	Ann Arbor	Michigan
United States	VA Medical Center	Durham	North Carolina
United States	Center for Health Equity Research and Promotion	Pittsburgh	Pennsylvania
United States	VA Medical Center, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Levy MH, Back A, Benedetti C, Billings JA, Block S, Boston B, Bruera E, Dy S, Eberle C, Foley KM, Karver SB, Knight SJ, Misra S, Ritchie CS, Spiegel D, Sutton L, Urba S, Von Roenn JH, Weinstein SM. NCCN clinical practice guidelines in oncology: palliative — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge, risk perception, decision making, patient-physician communication		Prebiopsy or biopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Results visit (Time 3)	No
Secondary	satisfaction with decision aid, anxiety		Anxiety: Prebiopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Diagnosis visit (Time 3). Satisfaction: 7-10 Days After Results visit (Time 3)	No