Decision Support Workshop for Breast Reconstruction

NCT01857882 | Completed Results

• 1 other identifier: 11-1027-CE
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; breast reconstruction; shared decision making; decision support intervention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (10)

• Decision Conflict Scale

  Change from baseline decision conflict at 1 week after surgical consultation

• Decision Preference and Decision Choice

  baseline

• Patient Involvement in Care Scale (PICS)

  T1 (1 week after surgical consultation)

• Satisfaction With Information (Sub-scale of BREAST-Q)

  T1 (1 week after surgical consultation)

• Qualitative Interview Assessment

  Within three months after initial consultation

Other Outcomes (3)

• Recruitment Rate-feasibility Outcome

  Duration of recruiting, expected on average two months

• Retention After Randomized Treatment Assignment (Workshop and Consultation Attendance)-Feasibility Outcome

  Duration of treatment-8 hours on day of treatment

• Completion of Primary Outcome Measure-feasibility Outcome

  1 week after initial consultation

Study Arms (2)

Decision Support Workshop

EXPERIMENTAL

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.

Other: Decision Support Workshop

Standard Care

NO INTERVENTION

Routine pre-consultation education

Interventions

Decision Support Workshop 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

Decision Support Workshop

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (2)

• 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.

  PMID: 25351455 RESULT

• 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.

  PMID: 23829442 DERIVED

Related Links

• E-publication link

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Toni Zhong
• Organization: University Health Network

toni.zhong@uhn.ca

416-340-3858

Study Officials

• Toni Zhong, MD, MHS

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 20, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 17, 2015
• Results First Posted: June 17, 2015

Record last verified: 2015-06

Locations

CA (1)