Clinical trial NCT04817709: Development of a Patient Decision Aid for Women Considering Breast Reconstruction
Official title: Development of a Patient Decision Aid for Women Considering Breast Reconstruction: User-Centered Design and Field-Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are considering breast reconstruction surgery after mastectomy

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Delivery Rate
timeFrame: Up to 3 months prior to plastic surgery consultation
Secondary outcomes:
measure: Breast Reconstruction Knowledge Questionnaire
timeFrame: Up to 3 months prior to plastic surgery consultation
measure: Preparation for Decision Making Scale
timeFrame: Immediately after intervention
measure: Decisional Conflict Scale
timeFrame: Immediately before intervention, immediately after intervention, immediately after consultation
measure: BREAST-Questionnaire (Q)
timeFrame: Up to 1 year prior to surgery, up to 1 year after surgery
measure: Type of surgery completed
timeFrame: Up to 1 year after surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Gregory Reece
role: PRINCIPAL_INVESTIGATOR
References: