Shared Decision Making with breast cancer patients - does it work? The randomized DBCG RT SDM trial
Stine Rauff Søndergaard,
Denmark
OC-0759
Abstract
Shared Decision Making with breast cancer patients - does it work? The randomized DBCG RT SDM trial
Authors: Stine Rauff Søndergaard1, Troels Bechmann2, Birgitte Vrou Offersen3, Anders WM Nielsen3, Mette Holck Nielsen4, Mette Møller5, Leonard L. Berry6, Robert Zachariaee7, Karina Dahl Steffensen8
1Lillebaelt Hospital – University Hospital of Southern Denmark, Department of Oncology, Vejle, Denmark; 2Regional Hospital West, Department of Oncology, Herning, Denmark; 3Aarhus University Hospital, Department of Experimental Clinical Oncology & Department of Oncology, Aarhus, Denmark; 4Odense University Hospital, Department of Oncology, Odense, Denmark; 5Aalborg University Hospital, Department of Oncology, Aalborg, Denmark; 6College Station, Texas A&M University, Texas, USA; 7Aarhus University, Department of Psychology and Behavioral sciences, Aarhus, Denmark; 8Lillebaelt Hospital – University Hospital of Southern Denmark, Center for Shared Decision Making, Vejle, Denmark
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Purpose or Objective
Shared decision making (SDM) is a patient-engaging process and is especially advocated for preference-sensitive decisions, such as adjuvant treatment for early breast cancer. The Danish Breast Cancer Group Radiotherapy (DBCG RT) Committee has completed a randomized multicenter trial to provide evidence in the implementation of SDM for Danish breast cancer patients. A generic, in-consult patient decision aid template (PtDA) has previously been developed. The PtDA was adjusted to support SDM on adjuvant whole-breast irradiation. The primary objective was to investigate whether the adjusted in-consult PtDA affects patient-reported SDM on adjuvant radiotherapy. NCT04177628.
Material and Methods
Doctors at four radiotherapy departments were randomized to either continue usual practice or receive a 30-minutes introduction to SDM and use an in-consult PtDA. Eligible patients were candidates for adjuvant whole-breast irradiation after breast-conserving surgery. The primary endpoint was patient-reported SDM in clinical encounters measured by the SDM-Q-9 questionnaire. Other endpoints were patient-reported SDM measured by the SDMP4 questionnaire and the CollaboRATE questionnaire, doctor-reported SDM, patient-reported decisional conflict, decision regret after 6 months, fear of cancer recurrence, patient knowledge about RT, and health-related quality of life. Inclusion of 662 patients were required to ensure a statistical power of 80 % and to account for 10 % dropout.
Results
The inclusion ended on the 31st of December 2022. Of the 678 included patients, 633 responded to SDM-Q-9. A Generalized Estimating Equation (GEE) population-averaged model with the departments as clusters were performed. For the SDM-Q-9 questionnaire (range 0-100), the PtDA cohort reported significantly more SDM compared to the control cohort with a β 9.49 (95% CI 8.92-10.06, p<0.0001). The SDM-Q-9 average in the control cohort (intercept) was 59.72 (95% CI 54.24-65.21, p<0.0001). For the SDMP4 questionnaire (range 0-4), the PtDA cohort reported more SDM with a β 0.48 (95% CI 0.33-0.63, p<0.0001), intercept at 1.65 (95% CI 1.14-2.16, p<0.0001). For the CollaboRATE questionnaire (range 0- 9), the PtDA cohort reported more SDM with a β 0.62 (95% CI 0.38-0.86, p<0.0001), intercept at 6.70 (95% CI 5.90-7.43, p<0.0001). In the PtDA cohort, 33% of the patients reported the maximum score for all three questions in the CollaboRATE questionnaire compared to only 17% in the control cohort.
Conclusion
In-consult use of a PtDA increases patient-reported SDM. The present trial provides evidence on the impact of an in-consult PtDA and may thus pave the way for future implementation of SDM in oncology and beyond. The adjusted PtDA about adjuvant whole-breast radiotherapy decision making may be recommended as standard care.