Decision Support Workshop for Breast Reconstruction

Breast Cancer Clinical Trial

— DSW  

Official title:

Breast Reconstruction Decision Workshop Pilot RCT (Randomized Controlled Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01857882
• Other study ID #: 11-1027-CE
• Status: Completed
• Phase: N/A
• First received: May 6, 2013
• Last updated: June 16, 2015
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• 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

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 rand — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Recruitment Rate-feasibility Outcome	As this is a pilot study, the feasibility of conducting the study is highly important. The recruitment rate of participants will be measured, during the recruiting period which is expected to be on average two months.	Duration of recruiting, expected on average two months	No
Other	Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome	The number of participants who completed their assigned treatment (workshop and consultation vs. consultation alone) will be recorded. This will be recorded directly after each day the treatment is delivered.	Duration of treatment-8 hours on day of treatment	No
Other	Completion of Primary Outcome Measure-feasibility Outcome	Patients are to complete the primary outcome one week after initial consultation. However, it is expected that some patients may take longer to complete this intervention (on average 1 month after consultation), and will require reminder telephone calls.	1 week after initial consultation	No
Primary	Decision Self-efficacy Scale	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.	Change from baseline decision self-efficacy at 1 week after surgical consultation	No
Secondary	Decision Conflict Scale	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).	Change from baseline decision conflict at 1 week after surgical consultation	No
Secondary	Decision Preference and Decision Choice	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.	baseline	No
Secondary	Patient Involvement in Care Scale (PICS)	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.	T1 (1 week after surgical consultation)	No
Secondary	Satisfaction With Information (Sub-scale of BREAST-Q)	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.	T1 (1 week after surgical consultation)	No
Secondary	Qualitative Interview Assessment	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.	Within three months after initial consultation	No
Secondary	Uptake Rate of Breast Reconstruction-Service Outcome	The uptake rate of breast reconstruction (if patients chose breast reconstruction or no reconstruction)	Six months after initial consultation	No
Secondary	Length of Consultation-service Outcome	The length of the initial consultation with the plastic surgeon, measured in minutes. Consultations are expected to be between 20-60 mins.	Duration of initial consultation	No
Secondary	Number of Consultations-service Outcomes	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.	Six months after initial consultation	No
Secondary	Breast Reconstruction Knowledge Test	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.	Change in baseline breast reconstruction knowledge at 1 week after initial consultation	No
Secondary	Medical Outcomes Study Social Support Survey	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.	baseline	No

External Links

•   E-publication link