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

Abstract

BackgroundThe Pre-Consultation Educational Group Intervention pilot study seeks to assess the feasibility and inform the optimal design for a definitive randomized controlled trial that aims to improve the quality of decision-making in postmastectomy breast reconstruction patients.Methods/designThis is a mixed-methods pilot feasibility randomized controlled trial that will follow a single-center, 1:1 allocation, two-arm parallel group superiority design.Setting: The University Health Network, a tertiary care cancer center in Toronto, Canada.Participants: Adult women referred to one of three plastic and reconstructive surgeons for delayed breast reconstruction or prophylactic mastectomy with immediate breast reconstruction.Intervention: We designed a multi-disciplinary educational group workshop that incorporates the key components of shared decision-making, decision-support, and psychosocial support for cancer survivors prior to the initial surgical consult. The intervention consists of didactic lectures by a plastic surgeon and nurse specialist on breast reconstruction choices, pre- and postoperative care; a value-clarification exercise led by a social worker; and discussions with a breast reconstruction patient.Control: Usual care includes access to an informational booklet, website, and patient volunteer if desired.Outcomes: Expected pilot outcomes include feasibility, recruitment, and retention targets. Acceptability of intervention and full trial outcomes will be established through qualitative interviews. Trial outcomes will include decision-quality measures, patient-reported outcomes, and service outcomes, and the treatment effect estimate and variability will be used to inform the sample size calculation for a full trial.DiscussionOur pilot study seeks to identify the (1) feasibility, acceptability, and design of a definitive RCT and (2) the optimal content and delivery of our proposed educational group intervention. Thirty patients have been recruited to date (8 April 2013), of whom 15 have been randomized to one of three decision support workshops. The trial will close as planned in May 2013.Trial registrationNCT01857882

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

“…As a result, we developed a pre-consultation educational group intervention delivered in a group setting to women considering breast reconstruction. The pilot randomized controlled trial (RCT) protocol was previously published [15]. The aim of this pilot study was to determine feasibility, treatment effect estimates, and variance to inform the primary and secondary outcomes for a full-scale RCT.…”

Shared medical appointments as a new model for carpal tunnel surgery consultation: A randomized clinical trial

“…A final ethical consideration is that physicians should avoid situations in which an outside observer's presence may negatively influence the medical interaction. Previous studies have found that rather than feeling coerced, patients respond positively to group education (11,14,15,34). Although this was not quantified, many patients in the current study expressed a positive opinion of the process and of the patients screened for the study who declined participation, none stated potential involvement in an SMA as the cause.…”

“…SMAs (11,(14)(15)(16)(17). SMAs are now implemented in internal medicine, neurology and some low-variation surgeries, but there has not yet been an evaluation of whether SMAs impact surgical risk recall (11,12,(17)(18)(19)(20).…”

Impact of the Poly Implant Prosthesis Breast Implants Recall in Women With Breast Reconstruction: A South-Eastern French Cross-Sectional Survey Nested in a Prospective Cohort

“…31,32 Post-decisional regrets were observed more frequently in our study when the decision-making was not felt to be sufficiently proactive and in those who were less satisfied with their Breast Reconstruction. The impact of shared decision-making is certainly worth investigating in this context 34,35 with facilitating interventions. 36,37 The main limitation of our study was that some of the sub-groups, such as the PIP Breast Implant and the autologous Breast reconstruction sub-groups, were very small, which reduced the statistical power of some of the analyses.…”