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. 2022 Mar 15;14(6):1500.
doi: 10.3390/cancers14061500.

Decisional Conflict after Deciding on Potential Participation in Early Phase Clinical Cancer Trials: Dependent on Global Health Status, Satisfaction with Communication, and Timing

Liza G G van Lent  1 , Maja J A de Jonge  1 , Mirte van der Ham  1 , Marjolein van Mil  2 , Eelke H Gort  3 , Jeroen Hasselaar  4 , Esther Oomen-de Hoop  1 , Carin C D van der Rijt  1 , Julia C M van Weert  5 , Martijn P Lolkema  1
Affiliations

Decisional Conflict after Deciding on Potential Participation in Early Phase Clinical Cancer Trials: Dependent on Global Health Status, Satisfaction with Communication, and Timing

Liza G G van Lent et al. Cancers (Basel). .

Abstract

When standard treatment options are not available anymore, patients with advanced cancer may participate in early phase clinical trials. Improving this complex decision-making process may improve their quality of life. Therefore, this prospective multicenter study with questionnaires untangles several contributing factors to decisional conflict (which reflects the quality of decision-making) in patients with advanced cancer who recently decided upon early phase clinical trial participation (phase I or I/II). We hypothesized that health-related quality of life, health literacy, sense of hope, satisfaction with the consultation, timing of the decision, and the decision explain decisional conflict. Mean decisional conflict in 116 patients was 30.0 (SD = 16.9). Multivariate regression analysis showed that less decisional conflict was reported by patients with better global health status (β = −0.185, p = 0.018), higher satisfaction (β = −0.246, p = 0.002), and who made the decision before (β = −0.543, p < 0.001) or within a week after the consultation (β = −0.427, p < 0.001). These variables explained 37% of the variance in decisional conflict. Healthcare professionals should realize that patients with lower global health status and who need more time to decide may require additional support. Although altering such patient intrinsic characteristics is difficult, oncologists can impact the satisfaction with the consultation. Future research should verify whether effective patient-centered communication could prevent decisional conflict.

Keywords: decision making; early phase clinical trials; health literacy; hope; patient satisfaction; quality of life.

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Conflict of interest statement

C.C.D.v.d.R. has received the grant from Dutch Cancer Society for the conduct of the study, and a personal fee from Kyowa Kirin BV and Ipsen Pharmaceutica BV (both outside the submitted work). M.P.L. reports grants from Astellas Pharma BV, Janssen Cilag BV, Sanofi Aventis Netherlands BV, Merck Sharp, and Dohme BV, and payment or honoraria from Amgen, Janssen Cilag, Bayer, Servier, Roche, INCa, Pfizer, Astellas, Astra Zeneca, Merck, Novartis, and Julius Clinical (all outside the submitted work). The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Flowchart for the inclusion of patients.
Figure 2
Figure 2
Model of predictors for decisional conflict.
See this image and copyright information in PMC

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References

    1. van Lent L.G.G., Jabbarian L.J., van Gurp J., Hasselaar J., Lolkema M.P., van Weert J.C.M., van der Rijt C.C.D., de Jonge M.J.A. Identifying patient values impacting the decision whether to participate in early phase clinical cancer trials: A systematic review. Cancer Treat. Rev. 2021;98:102217. doi: 10.1016/j.ctrv.2021.102217. - DOI - PubMed
    1. Greenfield S., Kaplan S., Ware J.E. Expanding patient involvement in care: Effects on patient outcomes. Ann. Intern. Med. 1985;102:520–528. doi: 10.7326/0003-4819-102-4-520. - DOI - PubMed
    1. Greenfield S., Kaplan S.H., Ware J.E., Yano E.M., Frank H.J.L. Patients’ participation in medical care. J. Gen. Intern. Med. 1988;3:448–457. doi: 10.1007/BF02595921. - DOI - PubMed
    1. Sepucha K.R., Borkhoff C.M., Lally J., Levin C.A., Matlock D.D., Ng C.J., Ropka M.E., Stacey D., Joseph-Williams N., Wills C.E., et al. Establishing the effectiveness of patient decision aids: Key constructs and measurement instruments. BMC Med. Inform. Decis. Mak. 2013;13:S12. doi: 10.1186/1472-6947-13-S2-S12. - DOI - PMC - PubMed
    1. Garvelink M.M., Boland L., Klein K., Nguyen D.V., Menear M., Bekker H.L., Eden K.B., LeBlanc A., O’Connor A.M., Stacey D. Decisional conflict scale findings among patients and surrogates making health decisions: Part II of an anniversary review. Med. Decis. Mak. 2019;39:316–327. doi: 10.1177/0272989X19851346. - DOI - PubMed

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