Clinical trial NCT01857882: Decision Support Workshop for Breast Reconstruction
Official title: Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
breast reconstruction
shared decision making
decision support intervention
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Physicians' Services Incorporated Foundation
First posted: 2013-05-20
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decision Self-efficacy Scale
timeFrame: Change from baseline decision self-efficacy at 1 week after surgical consultation
Secondary outcomes:
measure: Decision Conflict Scale
timeFrame: Change from baseline decision conflict at 1 week after surgical consultation
measure: Decision Preference and Decision Choice
timeFrame: baseline
measure: Patient Involvement in Care Scale (PICS)
timeFrame: T1 (1 week after surgical consultation)
measure: Satisfaction With Information (Sub-scale of BREAST-Q)
timeFrame: T1 (1 week after surgical consultation)
measure: Qualitative Interview Assessment
timeFrame: Within three months after initial consultation
measure: Uptake Rate of Breast Reconstruction-Service Outcome
timeFrame: Six months after initial consultation
measure: Length of Consultation-service Outcome
timeFrame: Duration of initial consultation
measure: Number of Consultations-service Outcomes
timeFrame: Six months after initial consultation
measure: Breast Reconstruction Knowledge Test
timeFrame: Change in baseline breast reconstruction knowledge at 1 week after initial consultation
measure: Medical Outcomes Study Social Support Survey
timeFrame: baseline
Other outcomes:
measure: Recruitment Rate-feasibility Outcome
timeFrame: Duration of recruiting, expected on average two months
measure: Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome
timeFrame: Duration of treatment-8 hours on day of treatment
measure: Completion of Primary Outcome Measure-feasibility Outcome
timeFrame: 1 week after initial consultation
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Toni Zhong, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Causarano N, Platt J, Baxter NN, Bagher S, Jones JM, Metcalfe KA, Hofer SO, O'Neill AC, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making for postmastectomy breast reconstruction: a pilot randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.
citation: Platt J, Baxter N, Jones J, Metcalfe K, Causarano N, Hofer SO, O'Neill A, Cheng T, Starenkyj E, Zhong T. Pre-consultation educational group intervention to improve shared decision-making in postmastectomy breast reconstruction: study protocol for a pilot randomized controlled trial. Trials. 2013 Jul 6;14:199. doi: 10.1186/1745-6215-14-199.