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- Title
The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction: study protocol of a multicenter randomized controlled trial.
- Authors
ter Stege, Jacqueline A.; Woerdeman, Leonie A. E.; Hahn, Daniela E. E.; van Huizum, Martine A.; van Duijnhoven, Frederieke H.; Kieffer, Jacobien M.; Retèl, Valesca P.; Sherman, Kerry A.; Witkamp, Arjen J.; Oldenburg, Hester S. A.; Bleiker, Eveline M. A.
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>This study is retrospectively registered at ClinicalTrials.gov ( NCT03791138 ).
- Subjects
MAMMAPLASTY; BREAST cancer; RANDOMIZED controlled trials; PATIENT decision making; BREAST; PLASTIC surgeons
- Publication
BMC Medical Informatics & Decision Making, 2019, Vol 19, Issue 1, pN.PAG
- ISSN
1472-6947
- Publication type
journal article
- DOI
10.1186/s12911-019-0873-1