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Completed

NCT Number: NCT00471601

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster Children's Hospital at Hamilton Health Sciences, Hamilton, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counseling Intervention

Behavioral

Questionnaire Administration

Behavioral

psychosocial assessment and care

Behavioral

Quality-of-Life Assessment

Behavioral

Primary outcomes

  1. Item reduction

    Time frame: 2 years

  2. Psychometric evaluation

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • McMaster University
  • National Cancer Institute (NCI)
  • The New School for Social Research
  • University College, London

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2023
Study completion
2023
First posted
May 10, 2007
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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