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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

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

Authors: Jennica Platt, Nancy Baxter, Jennifer Jones, Kelly Metcalfe, Natalie Causarano, Stefan OP Hofer, Anne ONeill, Terry Cheng, Elizabeth Starenkyj, Toni Zhong

Published in: Trials | Issue 1/2013

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Abstract

Background

The 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/design

This 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.

Discussion

Our 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 registration

NCT01857882
Appendix
Available only for authorised users
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Metadata
Title
Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial
Authors
Jennica Platt
Nancy Baxter
Jennifer Jones
Kelly Metcalfe
Natalie Causarano
Stefan OP Hofer
Anne ONeill
Terry Cheng
Elizabeth Starenkyj
Toni Zhong
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-199

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