Optimizing Decision Making About Breast Reconstruction After Mastectomy: A Patient-Centered Approach

The Washington University

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"; Other: Decision tool; Other: Demographic and Background Questions; Other: Usual Care Group - Outcome Measures; Other: Decision Group - Outcome Measures

Study type: Interventional

Funder types: Other

Identifiers

NCT03346161

201701045

Details and patient eligibility

About

Although clinical decision tools (CDTs) exist for a variety of treatments, CDTs designed to support personalized breast reconstruction decisions, particularly about type and timing of reconstruction, are lacking. The objective of this proposal is to develop and pilot test a clinical decision tool that provides personalized risk information and reflects patients' preferences and clinical needs.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Newly diagnosed or recurrent breast cancer
• Considering a referral or already referred to a plastic surgeon by their surgical oncologist for possible reconstruction
• Considering or completing a mastectomy.
• Does not have known distant metastatic disease (stage IV disease) at the time of recruitment
• Female.
• English-speaking.
• At least 18 years of age.
• Able to understand and willing to sign an IRB-approved written informed consent document.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Arm 1: BREASTChoice (Decision Tool)

Experimental group

Description:

Investigators recruited patients scheduled for a plastic/reconstruction consult. Investigators identified patients who completed a mastectomy, or were scheduled for one, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or offered them the option to complete pre-appointment procedures at home. Patients randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with the decision tool. They were asked to answer a survey. After the appointment, the team collected information consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

Treatment:

Other: Decision Group - Outcome Measures

Other: Decision tool

Other: Demographic and Background Questions

Arm 2: Enhanced Usual Care (Surgical Care Booklet)

Active Comparator group

Description:

Investigators recruited patients scheduled for plastic/reconstruction consultation. Investigators identified patients who completed or scheduled a mastectomy, and considering reconstruction, but didn't have an appointment with a plastic/reconstructive surgeon. A study team member called the patient to determine their interest and offered for them to come to their scheduled appointment 30 minutes early to meet a coordinator or to complete the pre-appointment procedures at home. Patients were randomized using computer random assignment. If the patient didn't have an appointment, she scheduled a convenient time to complete study procedures with research staff. Patients interacted with American Society of Plastic Surgeons booklet "Breast Reconstruction." They were asked to answer a survey. After the appointment, the team collected information about consult duration, decision process quality, and measures of shared decision making. Patient participation was approximately 30 minutes.

Treatment:

Other: Usual Care Group - Outcome Measures

Other: Usual care American Society of Plastic Surgeons booklet "Breast Reconstruction"

Other: Demographic and Background Questions