Development of a Patient Decision Aid for Women Considering Breast Reconstruction

Completed

Conditions studied: Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT04817709

Run by

M.D. Anderson Cancer Center

People needed

126

Starts

2017-03-20

Expected to finish

2021-05-20

Last updated by the study team

2021-05-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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