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213 Results of the randomized Danish breast cancer group radiotherapy shared decision making trial
  1. Stine Rauff Søndergaard1,2,3,
  2. Troels Bechmann4,
  3. Else Maae1,
  4. Anders WM Nielsen5,11,
  5. Mette Holck Nielsen6,
  6. Mette Møller7,
  7. Signe Timm1,3,
  8. Ebbe Laugaard Lorenzen8,
  9. Leonard L Berry9,
  10. Robert Zachariae10,11,
  11. Birgitte Vrou Offersen5,11,
  12. Karina Dahl Steffensen2,3
  1. 1Department of Oncology, Lillebaelt Hospital – University Hospital of Southern Denmark, Vejle, Denmark
  2. 2Center for Shared Decision Making, Lillebaelt Hospital – University Hospital of Southern Denmark, Vejle, Denmark
  3. 3Institute of Regional Health Research, Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark
  4. 4Department of Oncology, Regional Hospital West, Herning, Denmark
  5. 5Department of Experimental Clinical Oncology, Aarhus University Hospital, Aarhus, Denmark
  6. 6Department of Oncology, Odense University Hospital, Odense, Denmark
  7. 7Department of Oncology, Aalborg University Hospital, Aalborg, Denmark
  8. 8Laboratory of Radiation Physics, University of Southern Denmark, Denmark
  9. 9Texas AandM University, College Station, Texas, USA
  10. 10Department of Psychology and Behavioral sciences, Aarhus University, Aarhus, Denmark
  11. 11Department of Oncology, Aarhus University Hospital, Aarhus, Denmark


Introduction Shared decision-making is crucial when facing preference-sensitive options, such as adjuvant treatment after early breast cancer. Often, patients may not recognize they are in a decision making situation, and doctors rely on guidelines with limited room for individual considerations. The primary aim was to assess if a patient decision aid (PtDA) influences patient-reported shared decision making (SDM) in adjuvant radiotherapy and whether this resulted in adverse effects, such as increased fear of cancer recurrence and decision regret.

Methods In a multicenter randomized study initiated in collaboration with the Danish Breast Cancer Group Radiotherapy Committee, doctors at four radiotherapy departments were randomly assigned to either continue their usual practice or receive a 30-minute introduction to Shared Decision Making (SDM) and to use an in-consult PtDA developed from a Danish PtDA generic template, the Decision Helper (DH). Eligible patients were those offered adjuvant whole-breast irradiation after breast-conserving surgery for early, node-negative breast cancer. The primary endpoint was patient-reported SDM, measured by the SDM-Q-9 questionnaire, with secondary endpoints including decision regret and fear of cancer recurrence after 6 months. NCT04177628.

Results Of the 674 enrolled patients, 633 responded to SDM-Q-9. In the DH cohort the median for SDM was significantly higher at 80.0 (68.9–96.4) compared to 71.1 (55.5–82.2) in the control cohort, p<0.01. No significant differences in fear of cancer recurrence or decision regret after six months were found.

Discussion The present trial provides evidence on the impact of an in-consult DH and may thus pave the way for future implementation of SDM in oncology and beyond.

Conclusion In-consult use of a DH increases patient-reported SDM with no sign of increament of fear of cancer recurrence or decision regret. The DH is now recommended in the Danish national guideline on adjuvant whole-breast irradiation after early breast cancer.

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