NCT00471601

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2007

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2023

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

16.8 years

First QC Date

May 8, 2007

Last Update Submit

December 28, 2023

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (2)

  • Item reduction

    2 years

  • Psychometric evaluation

    2 years

Study Arms (1)

Interviews/Questionnaires

EXPERIMENTAL

The primary intervention in part 1 includes the interview for item generation with 50 women and the pilot-testing with a separate group of n = 30 women. The primary intervention in part 2 and 3 is the administration of the questionnaire. In part 3, along with the questionnaire being developed, the Body Image Scale (BIS), the Life Orientation Test-Revised (LOT-R), and the upcoming MSKCC BREAST-Q will be given to determine convergent and discriminant construct validity. No other therapeutic or diagnostic agents will be administered.

Behavioral: counseling interventionBehavioral: questionnaire administrationBehavioral: psychosocial assessment and careBehavioral: quality-of-life assessment

Interventions

counseling interventionBEHAVIORAL
Interviews/Questionnaires
questionnaire administrationBEHAVIORAL
Interviews/Questionnaires
psychosocial assessment and careBEHAVIORAL
Interviews/Questionnaires
quality-of-life assessmentBEHAVIORAL
Interviews/Questionnaires

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

New School for Social Research

New York, New York, 10003, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Colleen McCarthy, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

  • Peter G. Cordeiro, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2007

First Posted

May 10, 2007

Study Start

March 13, 2007

Primary Completion

December 22, 2023

Study Completion

December 22, 2023

Last Updated

January 2, 2024

Record last verified: 2023-12

Locations

GB(1)US(2)CA(1)