NCT04817709

Development of a Patient Decision Aid for Women Considering Breast Reconstruction

Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 126 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Educational Intervention	Review workbook
OTHER	Usual Care	Receive educational materials
OTHER	Media Intervention	Watch video
OTHER	Medical Chart Review	Review of medical records
OTHER	Questionnaire Administration	Complete questionnaires

Timeline

• Start date: 2017-03-20
• Primary completion: 2021-05-20
• Completion: 2021-05-20
• First posted: 2021-03-26
• Last updated: 2021-05-24

Locations

1 site across 1 country: United States