Development of a Patient Decision Aid for Women Considering Breast Reconstruction

M.D. Anderson Cancer Center

Status: Completed

Conditions: Breast Carcinoma

Treatments: Other: Usual Care; Other: Educational Intervention; Other: Medical Chart Review; Other: Media Intervention; Other: Questionnaire Administration

Study type: Observational

Funder types: Other

Identifiers

NCT04817709

PA17-0002 (Other Identifier)

NCI-2020-07838 (Registry Identifier)

Details and patient eligibility

About

This study engages cancer survivors who have considered breast reconstruction after mastectomy in developing and pilot testing an up-to-date, understandable, meaningful patient decision aid video and workbook. Once the video and workbook are pilot-tested, a field test with new patients will then compare whether it is more feasible and useful for women considering breast reconstruction after mastectomy to view a video and workbook before their appointment or an educational booklet during their appointment. The video explains the process and types of reconstruction, the timeline for how breast reconstruction is done, and how the cost of this surgery is covered. The workbook helps patients compare your options and prepare for the appointment. The educational booklet explains the same process, types, timeline and costs, and is designed to help the patient and their surgeon compare and discuss the options together during the appointment. By comparing these two methods, researchers may learn which of these is more effective in helping patients make a decision about breast reconstruction.

Full description

PRIMARY OBJECTIVES:

I. To design a patient decision aid video about breast reconstruction. II. To pilot test its acceptability with women. III. To field test the feasibility of delivery pre-consultation and efficacy at preparing women for their discussion with their plastic surgeon.

OUTLINE:

FOCUS GROUP: Survivors who previously considered breast reconstruction participate in a 40 to 60-minute focus group to gather feedback on currently-available patient decision aids and educational materials. The research team uses their feedback to create an initial prototype of a patient decision aid video

PILOT TEST: Survivors who previously considered breast reconstruction review the initial prototype of the patient decision aid video, then complete a questionnaire providing their feedback about the video's strengths and areas that could be improved. The research team then incorporates their feedback into the video."

FIELD TEST: Patients are randomized to 1 of 2 arms.

ARM I: Before their appointment, patients spend up to 30 minutes viewing a video and workbook. They also spend 5 to 10 minutes completing a questionnaire before and after the video and workbook, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.

ARM II: During their appointment, patients spend up to 30 minutes reviewing the standard educational booklet about breast reconstruction. They also spend 5 to 10 minutes completing a questionnaire before and after the booklet, and again after their appointment. After their appointment, the research assistant reviews their medical record to confirm what decisions the patient and doctor made about breast reconstruction.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aims 1 and 2: Patients who are 6 months to 3 years post-mastectomy surgery
• Aim 3: Patients who are scheduled for their first breast reconstruction consultation with plastic surgery
• Able to speak, read, and write English

Exclusion criteria

• Women with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in their medical record)
• Women for whom the video and workbook would not be appropriate due to clinical characteristics or contraindications (as determined by a provider)

Trial design

126 participants in 2 patient groups

Arm 1

Description:

Patients view a video and read a workbook over 30 minutes about breast reconstruction surgery before their appointment. Patients also complete a questionnaire over 5-10 minutes before and after the video and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any).

Treatment:

Other: Media Intervention

Other: Questionnaire Administration

Other: Medical Chart Review

Other: Educational Intervention

Arm 2

Description:

Patents receive an educational booklet about breast reconstruction surgery during appointment. Patients also complete a questionnaire over 5-10 minutes before and after talking with the plastic surgeon. Patients' medical records are reviewed once they have made a decision about the type of reconstruction (if any).

Treatment:

Other: Questionnaire Administration

Other: Medical Chart Review

Other: Usual Care