TY - JOUR
T1 - The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction
T2 - Study protocol of a multicenter randomized controlled trial
AU - Ter Stege, Jacqueline A.
AU - Woerdeman, Leonie A.E.
AU - Hahn, Daniela E.E.
AU - Van Huizum, Martine A.
AU - Van Duijnhoven, Frederieke H.
AU - Kieffer, Jacobien M.
AU - Retèl, Valesca P.
AU - Sherman, Kerry A.
AU - Witkamp, Arjen J.
AU - Oldenburg, Hester S.A.
AU - Bleiker, Eveline M.A.
N1 - Funding Information:
This trial is funded by the Dutch Cancer Society (Delflandlaan 17, 1062 EA, Amsterdam, The Netherlands) (grant number A6C/NKI 2014–7031). The funding body had, and will have, no role in the design of the study, the collection, analysis and interpretation of the data and in writing the manuscript.
Publisher Copyright:
© 2019 The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2019/8/19
Y1 - 2019/8/19
N2 - Background: Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness. Methods: A multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs. Discussion: This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision. Trial registration: This study is retrospectively registered at ClinicalTrials.gov (NCT03791138).
AB - Background: Most breast cancer patients undergoing mastectomy are candidates for breast reconstruction. Deciding about breast reconstruction is complex and the preference-sensitive nature of this decision requires an approach of shared decision making between patient and doctor. Women considering breast reconstruction have expressed a need for decision support. We developed an online patient decision aid (pDA) to support decision making in women considering immediate breast reconstruction. The primary aim of this study is to assess the impact of the pDA in reducing decisional conflict, and more generally, on the decision-making process and the decision quality. Additionally, we will investigate the pDA's impact on health outcomes, explore predictors, and assess its cost-effectiveness. Methods: A multicenter, two-armed randomized controlled trial (1:1) will be conducted. Women with breast cancer or ductal carcinoma in situ who will undergo a mastectomy and are eligible for immediate breast reconstruction will be invited to participate. The intervention group will receive access to the online pDA, whereas the control group will receive a widely available free information leaflet on breast reconstruction. Participants will complete online questionnaires at: baseline (T0), 1 week after consultation with a plastic surgeon (T1), and 3 (T2) and 12 months (T3) after surgery. The primary outcome is decisional conflict. Secondary outcomes include other measures reflecting the decision-making process and decision quality (e.g., decision regret), patient-reported health outcomes (e.g., satisfaction with the breasts) and costs. Discussion: This study will provide evidence about the impact of an online pDA for women who will undergo mastectomy and are deciding about breast reconstruction. It will contribute to the knowledge on how to optimally support women in making this difficult decision. Trial registration: This study is retrospectively registered at ClinicalTrials.gov (NCT03791138).
KW - Breast cancer
KW - Breast reconstruction
KW - Decisional conflict
KW - Patient decision aid
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85070869083&partnerID=8YFLogxK
U2 - 10.1186/s12911-019-0873-1
DO - 10.1186/s12911-019-0873-1
M3 - Article
C2 - 31426772
AN - SCOPUS:85070869083
SN - 1472-6947
VL - 19
JO - BMC Medical Informatics and Decision Making
JF - BMC Medical Informatics and Decision Making
IS - 1
M1 - 165
ER -