NCT02734121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

3.3 years

First QC Date

April 6, 2016

Last Update Submit

September 25, 2018

Conditions

Breast Cancer

Keywords

breast cancerbreast reconstructionshared decision makingdecision support intervention

Outcome Measures

Primary Outcomes (1)

  • Decisional 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

Study Arms (2)

Educational group intervention

EXPERIMENTAL

The pre-consultation educational group intervention will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.

Behavioral: pre-consultation educational group intervention

Standard Care

NO INTERVENTION

Routine pre-consultation education

Interventions

pre-consultation educational group interventionBEHAVIORAL

Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients. * Surgeon (40 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities * Registered nurse (20 mins): preparing for surgery, postoperative recovery and how to navigate the health care system * Social worker (30 mins): values clarification exercise * Breast reconstruction patient volunteers (30 mins) questions and answers about their personal experience

Educational group intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \> 18 years of age.
  • Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention.

You may not qualify if:

  • Chest wall or atypical breast malignancy that require chest wall reconstruction.
  • Active invasive or in situ breast cancer.
  • Consultation for breast revision or nipple reconstruction only.
  • Patient cannot read or write in English.
  • Cognitive impairment or uncontrolled psychiatric diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Related 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 randomized controlled trial. Support Care Cancer. 2015 May;23(5):1365-75. doi: 10.1007/s00520-014-2479-6. Epub 2014 Oct 29.

    PMID: 25351455RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Toni Zhong, MD, MHS

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

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

April 6, 2016

First Posted

April 12, 2016

Study Start

February 15, 2015

Primary Completion

June 15, 2018

Study Completion

September 15, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)