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Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial

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Abstract

Background

Patients with breast cancer encounter difficulties in making surgical treatment decisions. Shared decision-making (SDM) with patient decision aids (PDAs) can minimize patients’ decisional conflicts. However, the effect of PDAs in Asia remains inconclusive. This study investigated the effect of SDM assisted by PDAs on the decisional conflict of patients with breast cancer.

Methods

In this two-group, outcome assessor-blind, randomized controlled trial, 151 patients diagnosed as having breast cancer were assigned to the PDA (SDM with PDA) group or the standard (SDM without PDA) group. Demographic and clinical variables were analyzed to identify variables affecting the treatment choice. The patients’ decision-making difficulties were evaluated using the four-item SURE scale during preoperative hospitalization, and decisional conflicts were examined using the five-item Decision Regret scale and Hospital Anxiety and Depression Scale (HADS) 1 month after surgery.

Results

The choice of breast conservation therapy and mastectomy did not significantly differ between the PDA and standard groups. The PDA group had a higher level of depression after making decisions (P = 0.029) than did the standard group. No significant difference in the total scores of the SURE scale and Decision Regret scale were noted between the groups.

Conclusion

PDAs did not assist the patients with breast cancer in making breast surgery-related decisions. Clinicians should focus on SDM grounded in evidence-based medicine with care and help patients consider their individual preferences.

Trial registration

ClinicalTrial.gov, NCT03105076; April 7, 2017 (http://www.clinicaltrials.gov).

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Acknowledgements

We thank Miss Kai-Ling Tan for assistance with the English translation of the PDA and Wallace Academic Editing for the editing of the manuscript.

Author information

Author notes

  1. Shi-Qian Lin and Chih-Ming Su have contributed equally to this work.

Authors and Affiliations

  1. School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan

    Shi-Qian Lin

  2. Division of General Surgery, Department of Surgery, Shuang Ho Hospital, Taipei Medical University, New Taipei, Taiwan

    Chih-Ming Su, Hsueh-Chi Wu & Ka-Wai Tam

  3. Division of General Surgery, Department of Surgery, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan

    Chih-Ming Su & Ka-Wai Tam

  4. Shared Decision Making Resource Center, Shuang Ho Hospital, Taipei Medical University, 291, Zhongzheng Road, Zhonghe District, New Taipei City, 23561, Taiwan

    Yun-Yun Chou & Ka-Wai Tam

  5. Biostatistics and Research Consultation Center, Taipei Medical University, Taipei, Taiwan

    Yu-Chun Yen

  6. Cochrane Taiwan, Taipei Medical University, Taipei, Taiwan

    Ka-Wai Tam

Authors
  1. Shi-Qian Lin
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  4. Yun-Yun Chou
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  5. Yu-Chun Yen
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Contributions

Conception and design: KWT, Collection and assembly of data: SQL, CMS, HCW, YYC, and KWT. Data analysis and interpretation: SQL, CMS, HCW, YYC, YCY, and KWT, Manuscript writing: SQL, CMS, and KWT. Final proof reading and revision of manuscript: SQL, CMS, HCW, YYC, YCY, and KWT.

Corresponding author

Correspondence to Ka-Wai Tam.

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Conflict of interest

All authors have no conflict of interest or financial ties to disclose.

Ethical approval

The RCT was approved by the Joint Institutional Review Board of Taipei Medical University (Approval Number: N201702073).

Trial registration

ClinicalTrial.gov, NCT03105076; April 7, 2017.

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Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 Appendix. Breast cancer patient decision aid (PDF 533 kb)

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Lin, SQ., Su, CM., Wu, HC. et al. Effect of patient decision aids on decisional conflict and regret associated with breast cancer surgery: a randomized controlled trial. Breast Cancer 29, 880–888 (2022). https://doi.org/10.1007/s12282-022-01370-0

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  • DOI: https://doi.org/10.1007/s12282-022-01370-0

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