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Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

18 Years
79 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

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 ΒΌ 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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Decision self-efficacy

Outcome Description:

Decision self-efficacy (DSE) scale is a prospectively designed instrument to evaluate patient self-confidence in decision-making, including shared decision-making. It has been validated among women facing treatment decisions for osteoporosis and used in cancer patients. Psychometric evaluation has shown high levels of internal consistency (Cronbach alpha 0.90). Decision self-efficacy is correlated with decision conflict subscales of feeling informed (r = 0.47) and supported (r = 0.45). This instrument has never been tested in the breast cancer or breast reconstruction population.

Outcome Time Frame:

Change from baseline decision self-efficacy at 1 week after surgical consultation

Safety Issue:


Principal Investigator

Toni Zhong, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:




Start Date:

September 2012

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • breast cancer
  • breast reconstruction
  • shared decision making
  • decision support intervention
  • Breast Neoplasms