Testing the Helpfulness of 2 Decision Aids for Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT00432601 |
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Recruitment Status :
Completed
First Posted : February 8, 2007
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Behavioral: type of decision aid | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1028 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Official Title: | Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
Patients will receive Michigan Cancer Consortium decision aid.
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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. |
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Active Comparator: Arm 2
Patients will receive National Comprehensive Cancer Network decision aid.
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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. |
- Knowledge [ Time Frame: 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00432601
| United States, California | |
| VA Medical Center, San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Michigan | |
| VA Ann Arbor Healthcare System | |
| Ann Arbor, Michigan, United States, 48113-0170 | |
| United States, North Carolina | |
| VA Medical Center | |
| Durham, North Carolina, United States, 27705 | |
| United States, Pennsylvania | |
| Center for Health Equity Research and Promotion | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Principal Investigator: | Angela Fagerlin, PhD MA | VA Ann Arbor Healthcare System |
Publications of Results:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT00432601 History of Changes |
| Other Study ID Numbers: |
IIR 05-283 |
| First Posted: | February 8, 2007 Key Record Dates |
| Results First Posted: | March 22, 2016 |
| Last Update Posted: | March 22, 2016 |
| Last Verified: | March 2016 |
Keywords provided by VA Office of Research and Development:
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decision aid prostate cancer patient-physician communication decision making literacy |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |