Skip to content

Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions

Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00471601
Enrollment
357
Registered
2007-05-10
Start date
2007-03-13
Completion date
2023-12-22
Last updated
2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

recurrent breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

Brief summary

RATIONALE: A questionnaire that evaluates a patient's expectations about breast reconstruction surgery may help doctors improve patient education before surgery and increase patient satisfaction after surgery. PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions.

Detailed description

OBJECTIVES: * Develop and validate a questionnaire to evaluate preoperative expectations about breast reconstruction in women with breast cancer or other conditions. * Determine variations in expectations related to patient characteristics. * Develop educational modules to help patients understand realistic outcomes. * Identify patient groups at risk for dissatisfaction. OUTLINE: This is a 3-part study. * Part 1 (first 80 patients): Both preoperative and postoperative patients (50 patients total) undergo an interview by a research study assistant about their expectations for breast reconstructive surgery. Some of these patients will also complete a pilot version of a questionnaire about their expectations for breast reconstructive surgery (30 patients total). * Part 2 (next 200 patients): Preoperative patients complete questionnaires (the preliminary questionnaire developed after part 1 and the MSKCC BREAST-Q \[Reconstruction Module\]) about their expectations for breast reconstructive surgery after patient education about breast reconstructive surgery. Some of these patients (100 patients) also complete the Brief Cope addressing emotional expression and emotional processing styles of coping, Impact of Events Scale, and Life Orientation Test-Revised (LOT-R) questionnaires. * Part 3 (final 200 patients): Preoperative patients complete a questionnaire (final questionnaire developed after part 2) about their expectations for breast reconstructive surgery after patient education about breast reconstruction and once after surgery. Patients also complete the Breast Reconstruction Outcomes Questionnaire (MSKCC BREAST-Q) once before surgery (after patient education) and once after surgery measuring patient satisfaction and quality of life. A small group of patients complete the Body Image Scale (BIS) and the LOT-R addressing body image, sexuality, personal well-being, and lifestyle.

Interventions

BEHAVIORALcounseling intervention
BEHAVIORALquestionnaire administration
BEHAVIORALpsychosocial assessment and care
BEHAVIORALquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
McMaster University
CollaboratorOTHER
University College, London
CollaboratorOTHER
The New School for Social Research
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Female. * Age \> or = to 18 to 75 years. * Patients who are presenting for consultation about breast reconstruction

Exclusion criteria

* Inability to speak or understanding English * Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability. * Prior breast reconstruction surgery.

Design outcomes

Primary

MeasureTime frame
Item reduction2 years
Psychometric evaluation2 years

Countries

Canada, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026