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Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial.
Oncologist. 2016 12; 21(12):1461-1470.O

Abstract

BACKGROUND

Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website.

METHODS

Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions.

RESULTS

Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group's (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate.

CONCLUSIONS

Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention.

IMPLICATIONS FOR PRACTICE

This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research.

Authors+Show Affiliations

Division of Public Health Sciences, Department of Surgery and Siteman Cancer Center, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA mpoliti@wustl.edu.Division of Public Health Sciences, Department of Surgery and Siteman Cancer Center, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.Department of Communication and Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, USA.Division of Public Health Sciences, Department of Surgery and Siteman Cancer Center, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.Division of Public Health Sciences, Department of Surgery and Siteman Cancer Center, Washington University in St. Louis School of Medicine, St. Louis, Missouri, USA.Department of Public Health Sciences, Department of Surgery and Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27511904

Citation

Politi, Mary C., et al. "Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial." The Oncologist, vol. 21, no. 12, 2016, pp. 1461-1470.
Politi MC, Kuzemchak MD, Kaphingst KA, et al. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial. Oncologist. 2016;21(12):1461-1470.
Politi, M. C., Kuzemchak, M. D., Kaphingst, K. A., Perkins, H., Liu, J., & Byrne, M. M. (2016). Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial. The Oncologist, 21(12), 1461-1470.
Politi MC, et al. Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial. Oncologist. 2016;21(12):1461-1470. PubMed PMID: 27511904.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Decision Aids Can Support Cancer Clinical Trials Decisions: Results of a Randomized Trial. AU - Politi,Mary C, AU - Kuzemchak,Marie D, AU - Kaphingst,Kimberly A, AU - Perkins,Hannah, AU - Liu,Jingxia, AU - Byrne,Margaret M, Y1 - 2016/08/10/ PY - 2016/02/17/received PY - 2016/06/13/accepted PY - 2016/8/12/pubmed PY - 2017/11/4/medline PY - 2016/8/12/entrez KW - Clinical trials KW - Decision aids KW - Informed decision making SP - 1461 EP - 1470 JF - The oncologist JO - Oncologist VL - 21 IS - 12 N2 - BACKGROUND: Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center's website. METHODS: Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center's website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. RESULTS: Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group's (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate. CONCLUSIONS: Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. IMPLICATIONS FOR PRACTICE: This paper describes evidence regarding a decision tool to support patients' decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients' preferences, promoting patient-centered care and the ethical conduct of clinical research. SN - 1549-490X UR - https://www.unboundmedicine.com/medline/citation/27511904/Decision_Aids_Can_Support_Cancer_Clinical_Trials_Decisions:_Results_of_a_Randomized_Trial_ L2 - https://doi.org/10.1634/theoncologist.2016-0068 DB - PRIME DP - Unbound Medicine ER -