Development of a Questionnaire to Evaluate Patient Expect... | NCT00471601

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

NCT00471601

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Jan 2, 2024Actual

Enrollment

357Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

counseling intervention
questionnaire administration
psychosocial assessment and care
quality-of-life assessment

Countries

United States
Canada
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
P30CA008748	U.S. NIH Grant/Contract		View source
MSKCC-07024

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 13, 2007Actual

Primary Completion Date

Dec 22, 2023Actual

Completion Date

Dec 22, 2023Actual

First Submitted Date

May 8, 2007

First Submission Date that Met QC Criteria

May 8, 2007

First Posted Date

May 10, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2023

Last Update Posted Date

Jan 2, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Memorial Sloan Kettering Cancer CenterOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH
McMaster University	OTHER
University College, London	OTHER
The New School for Social Research

Description Module

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.

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

357Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 intervention Behavioral: questionnaire administration Behavioral: psychosocial assessment and care Behavioral: quality-of-life assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
counseling intervention	Behavioral		Interviews/Questionnaires
questionnaire administration

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Item reduction		2 years
Psychometric evaluation		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen McCarthy, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator
Peter G. Cordeiro, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New School for Social Research		New York	New York	10003	United States
Memorial Sloan Kettering Cancer Center

References Module

Citations

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D003376	Counseling
D000067250	Psychiatric Rehabilitation

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D012046	Rehabilitation
D013812	Therapeutics