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Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial

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Abstract

Purpose

Breast cancer survivors who make preference-sensitive decisions about postmastectomy breast reconstruction often have large gaps in knowledge and undergo procedures that are misaligned with their treatment goals. We evaluated the feasibility and effect of a pre-consultation educational group intervention on the decision-making process for breast reconstruction.

Methods

We conducted a pilot randomized controlled trial (RCT) where participants were randomly assigned to the intervention with routine education or routine education alone. The outcomes evaluated were decisional conflict, decision self-efficacy, satisfaction with information, perceived involvement in care, and uptake of reconstruction following surgical consultation. Trial feasibility and acceptability were evaluated, and effect sizes were calculated to determine the primary outcome for the full-scale RCT.

Results

Of the 41 patients enrolled, recruitment rate was 72 %, treatment fidelity was 98 %, and retention rate was 95 %. The Cohen’s d effect size in reduction of decisional conflict was moderate to high for the intervention group compared to routine education (0.69, 95 % CI = 0.02–1.42), while the effect sizes of increase in decision self-efficacy (0.05, 95 % CI = −0.60–0.71) and satisfaction with information (0.11, 95 % CI = −0.53–0.76) were small. A higher proportion of patients receiving routine education signed informed consent to undergo breast reconstruction (14/20 or 70 %) compared to the intervention group (8/21 or 38 %) P = 0.06.

Conclusions

A pre-consultation educational group intervention improves patients’ shared decision-making quality compared to routine preoperative patient education. A full-scale definitive RCT is warranted based on high feasibility outcomes, and the primary outcome for the main trial will be decisional conflict.

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Acknowledgments

Funding was received from the Physician Services Incorporated Foundation (Dr. Platt—resident, Dr. Zhong—supervisor).

Ethical standards

This study was approved by the appropriate ethics committee (UHN REB).

Conflict of interest

The authors declare no financial relationship with the Physician Services Incorporated Foundation. The authors have full control of all primary data and agree to allow the journal to review the data if requested.

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Correspondence to Toni Zhong.

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Causarano, N., Platt, J., Baxter, N.N. et al. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer 23, 1365–1375 (2015). https://doi.org/10.1007/s00520-014-2479-6

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