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




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Trials

, 14:199

First Online: 06 July 2013Received: 18 May 2013Accepted: 26 June 2013DOI: 10.1186-1745-6215-14-199

Cite this article as: Platt, J., Baxter, N., Jones, J. et al. Trials 2013 14: 199. doi:10.1186-1745-6215-14-199

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

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-14-199 contains supplementary material, which is available to authorized users.

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Autor: Jennica Platt - Nancy Baxter - Jennifer Jones - Kelly Metcalfe - Natalie Causarano - Stefan OP Hofer - Anne ONeill - Terry

Fuente: https://link.springer.com/







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