Development of a Patient Decision Aid for Women Considering Breast Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

126 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-20

Study Completion Date

2021-05-20

Brief Summary

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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.

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Detailed Description

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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

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Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Arm 1

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).

Educational Intervention

Intervention Type OTHER

Review workbook

Media Intervention

Intervention Type OTHER

Watch video

Medical Chart Review

Intervention Type OTHER

Review of medical records

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Arm 2

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).

Usual Care

Intervention Type OTHER

Receive educational materials

Medical Chart Review

Intervention Type OTHER

Review of medical records

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Interventions

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Educational Intervention

Review workbook

Intervention Type OTHER

Usual Care

Receive educational materials

Intervention Type OTHER

Media Intervention

Watch video

Intervention Type OTHER

Medical Chart Review

Review of medical records

Intervention Type OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Chart Review

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No