Decision Support Workshop for Breast Reconstruction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

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Detailed Description

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Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This pilot study will be the first step in the evaluation of the educational group intervention and the results will be used to determine the feasibility and inform the optimal design for a definitive randomized controlled trial. This study will first examine the feasibility and acceptability of the intervention through implementation in a pilot, mixed-methods, 1:1 allocation parallel-arm randomized controlled trial.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Decision Support Workshop

The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.

Group Type EXPERIMENTAL

Decision Support Workshop

Intervention Type OTHER

Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

* Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
* Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
* Social worker (30 mins): values clarification exercise
* Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience

Standard Care

Routine pre-consultation education

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Decision Support Workshop

Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

* Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
* Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
* Social worker (30 mins): values clarification exercise
* Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient age: 18 - 79 years at the time of consultation
* In situ or invasive biopsy confirmed breast adenocarcinoma
* Considered for immediate or delayed breast reconstruction
* First consultation for breast reconstruction

Exclusion Criteria

* Chest wall or atypical breast malignancy (ex: angiosarcoma) or inflammatory adenocarcinoma of the breast
* Completion any phase of reconstruction, or for revision reconstruction
* Patient cannot read or write in English.
* Cognitive impairment or uncontrolled psychiatric diagnosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No