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Miller SM , Hudson SV , Egleston BL , Manne S , Buzaglo JS , Devarajan K , Fleisher L , Millard J , Solarino N , Trinastic J , Meropol NJ
The relationships among knowledge, self-efficacy, preparedness, decisional conflict, and decisions to participate in a cancer clinical trial
Psychooncology. 2013 Mar;22(3) :481-9
PMID: 22331643    PMCID: PMC3374030   
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BACKGROUND: Cancer clinical trials (CCTs) are important tools in the development of improved cancer therapies; yet, participation is low. Key psychosocial barriers exist that appear to impact a patient's decision to participate. Little is known about the relationship among knowledge, self-efficacy, preparation, decisional conflict, and patient decisions to take part in CCTs. OBJECTIVE: The purpose of this study was to determine if preparation for consideration of a CCT as a treatment option mediates the relationship between knowledge, self-efficacy, and decisional conflict. We also explored whether lower levels of decisional conflict are associated with greater likelihood of CCT enrollment. METHOD: In a pre-post test intervention study, cancer patients (N = 105) were recruited before their initial consultation with a medical oncologist. A brief educational intervention was provided for all patients. Patient self-report survey responses assessed knowledge, self-efficacy, preparation for clinical trial participation, decisional conflict, and clinical trial participation. RESULTS: Preparation was found to mediate the relationship between self-efficacy and decisional conflict (p = 0.003 for a test of the indirect mediational pathway for the decisional conflict total score). Preparation had a more limited role in mediating the effect of knowledge on decisional conflict. Further, preliminary evidence indicated that reduced decisional conflict was associated with increased clinical trial enrollment (p = 0.049). CONCLUSIONS: When patients feel greater CCT self-efficacy and have more knowledge, they feel more prepared to make a CCT decision. Reduced decisional conflict, in turn, is associated with the decision to enroll in a clinical trial. Our results suggest that preparation for decision-making should be a target of future interventions to improve participation in CCTs. Copyright (c) 2012 John Wiley & Sons, Ltd.
Miller, S M Hudson, S V Egleston, B L Manne, S Buzaglo, J S Devarajan, K Fleisher, L Millard, J Solarino, N Trinastic, J Meropol, N J P30 CA006927-48/CA/NCI NIH HHS/United States R01 CA158019-01/CA/NCI NIH HHS/United States England Psychooncology. 2013 Mar;22(3):481-9. doi: 10.1002/pon.3043. Epub 2012 Feb 14.