Decision Support Workshop for Breast Reconstruction

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Other: Decision Support Workshop

Registration Number: NCT01857882

Lead Sponsor: University Health Network, Toronto

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 41

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision Support Workshop	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.

Primary Outcome Measures

Name	Time	Method
Decision Self-efficacy Scale	Change from baseline decision self-efficacy at 1 week after surgical consultation	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. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (extremely low self-efficacy) to 100 (extremely high self-efficacy). The mean and standard deviation (SD) were calculated at baseline and after the initial consultation. Change in score was defined as the difference in total score between baseline and after consultation.

Secondary Outcome Measures

Name	Time	Method
Breast Reconstruction Knowledge Test	Change in baseline breast reconstruction knowledge at 1 week after initial consultation	This breast reconstruction knowledge test is a 12-item 3-response questionnaire that records the score on a continuous integer scale, and measured patient's knowledge regarding breast reconstruction.
Medical Outcomes Study Social Support Survey	baseline	Medical Outcomes Study Social Support Survey has a series of 18 questions that measure 4 domains of social support (emotional, tangible, affectionate, and social interactions). Responses range from 1 (none of the time) to 5 (all the time). The items in each domain were summed and then transformed to yield scores ranging from 0 to 100. Higher scores indicate more support.
Patient Involvement in Care Scale (PICS)	T1 (1 week after surgical consultation)	PICS is a measure of patient perception of involvement with her care, and has seven 5-point Likert scale items that assess the extent to which the patient asked questions, offered opinions, and expressed concerns when meeting with the surgeon.
Satisfaction With Information (Sub-scale of BREAST-Q)	T1 (1 week after surgical consultation)	The BREAST-Q is a procedure-specific and validated PRO that measures Hr-QOL and patient satisfaction with breast reconstruction. The "Satisfaction with Information" Subscale specifically measures patient satisfaction with the preoperative information and care provided by the plastic surgeon and other members of the medical team. There are 15 items that use a four-level Likert scale response format, the score is transformed on a scale of 0 to 100 with higher scores indicating greater satisfaction.
Qualitative Interview Assessment	Within three months after initial consultation	A subgroup of participants allocated to both the experimental and usual care groups will be asked to participate in a brief qualitative telephone interview. Purposeful sampling will be used to recruit 5 patients from each group to achieve data saturation and variability. Telephone interviews will be conducted by a social worker trained in qualitative methods. All participants randomized to the workshop will additionally be asked to complete a written survey for evaluation of the intervention immediately after participation in the workshop.
Decision Conflict Scale	Change from baseline decision conflict at 1 week after surgical consultation	Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).
Uptake Rate of Breast Reconstruction-Service Outcome	Six months after initial consultation	The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)
Decision Preference and Decision Choice	baseline	Decision Preference and Decision Choice has been used as a primary and secondary outcome in studies of decision support interventions in cancer patients. It demonstrates good test-retest reliability (test-retest coefficient \> 0.90) and is sensitive to change when measured before and after an intervention.
Length of Consultation-service Outcome	Duration of initial consultation	The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.
Number of Consultations-service Outcomes	Six months after initial consultation	The number of consultations with the plastic surgeon until the patient has made a reconstruction choice (defined as signing a surgical consent form) will be recorded. Patients can spend months considering their choices, so it is appropriate to follow them for a period of at least six months after their initial consultation.