Development of a Patient Decision Aid for Women Considering Breast Reconstruction

NCT04817709 | Completed

• 2 other identifiers: PA17-0002NCI-2020-07838
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Delivery Rate

  The statistician will calculate how many women to whom the research assistant was able to deliver the video/workbook or educational materials (i.e., by sending them the URL link or scheduling time to show them the video/workbook or educational materials on an iPad at the clinic), out of the total n = 130 eligible women. The statistician will also calculate the rates of women who prefer to view the video and workbook at home or at the clinic; and of women who re-visit the video and workbook after the consultation.

  Up to 3 months prior to plastic surgery consultation

Secondary Outcomes (5)

• Breast Reconstruction Knowledge Questionnaire

  Up to 3 months prior to plastic surgery consultation

• Preparation for Decision Making Scale

  Immediately after intervention

• Decisional Conflict Scale

  Immediately before intervention, immediately after intervention, immediately after consultation

• BREAST-Questionnaire (Q)

  Up to 1 year prior to surgery, up to 1 year after surgery

• Type of surgery completed

  Up to 1 year after surgery

Study Arms (2)

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).

Other: Educational Intervention; Other: Media Intervention; Other: Medical Chart Review; Other: Questionnaire Administration

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).

Other: Usual Care; Other: Medical Chart Review; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Review workbook

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 1

Usual Care OTHER

Receive educational materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 2

Media Intervention OTHER

Watch video

Arm 1

Medical Chart Review OTHER

Review of medical records

Also known as: Chart Review

Arm 1; Arm 2

Questionnaire Administration OTHER

Complete questionnaires

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are considering breast reconstruction surgery after mastectomy

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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Gregory Reece

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: March 26, 2021
• Study Start: March 20, 2017
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

US (1)