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

Jacqueline A. Ter Stege, Leonie A. E. Woerdeman, Daniela E. E. Hahn, Martine A. Van Huizum, Frederieke H. Van Duijnhoven, Jacobien M. Kieffer, Valesca P. Retèl, Kerry A. Sherman, Arjen J. Witkamp, Hester S.A. Oldenburg, Eveline M. A. Bleiker

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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).

LanguageEnglish
Article number165
Number of pages12
JournalBMC Medical Informatics and Decision Making
Volume19
Issue number1
DOIs
Publication statusPublished - 19 Aug 2019

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Decision Support Techniques
Mammaplasty
Randomized Controlled Trials
Breast Neoplasms
Decision Making
Mastectomy
Carcinoma, Intraductal, Noninfiltrating
Health
Cost-Benefit Analysis
Emotions
Breast
Referral and Consultation
Costs and Cost Analysis
Control Groups

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • breast cancer
  • breast reconstruction
  • decisional conflict
  • patient decision aid
  • randomized controlled trial

Cite this

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. / 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. In: BMC Medical Informatics and Decision Making. 2019 ; Vol. 19, No. 1.
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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. / 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.

In: BMC Medical Informatics and Decision Making, Vol. 19, No. 1, 165, 19.08.2019.

Research output: Contribution to journalArticleResearchpeer-review

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T1 - The impact of an online patient decision aid for women with breast cancer considering immediate breast reconstruction

T2 - BMC Medical Informatics and Decision Making

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 - Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

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).

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