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Questionnaire Development for Breast Reconstruction Expectations in Breast Cancer Patients

N/A

Waitlist Available

Led By Colleen McCarthy, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is developing a questionnaire to help doctors better understand patient expectations for breast reconstruction surgery. The hope is that this will help improve patient education and satisfaction with the surgery.

Who is the study for?

This trial is for women aged 18 to 75 who are considering breast reconstruction due to breast cancer or other conditions. Participants must be able to speak and understand English and provide informed consent. Women who've had prior breast reconstruction or have disabilities affecting consent are excluded.Check my eligibility

What is being tested?

The study is developing a questionnaire designed to gauge women's expectations regarding breast reconstruction surgery. The goal is to enhance patient education before the procedure and improve satisfaction afterwards through counseling, psychosocial care, and quality-of-life assessments.See study design

What are the potential side effects?

Since this trial involves non-medical interventions like questionnaires and counseling, there are no direct medical side effects associated with it. However, participants may experience emotional or psychological responses when discussing their expectations and experiences.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Item reduction

Psychometric evaluation

Side effects data

From 2017 Phase 2 trial • 14 Patients • NCT01732445

86%

Platelet count decreased

64%

Anemia

36%

White blood cell decreased

29%

Neutrophil count decreased

21%

Nausea

21%

Diarrhea

14%

Edema limbs

14%

Alanine aminotransferase increased

14%

Pain in extremity

14%

Hyperkalemia

14%

Hyponatremia

Upper respiratory infection

Anorexia

Urinary tract infection

Irregular menstruation

Myocardial infarction

General disorders and administration site conditions - Other, specify

Sudden death NOS

Lung infection

Intracranial hemorrhage

Transient ischemic attacks

Premature menopause

Periorbital edema

Photosensitivity

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Supportive Care (Ruxolitinib Phosphate and Danazol)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interviews/QuestionnairesExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

counseling intervention

2007

Completed Phase 3

~6710

questionnaire administration

2014

Completed Phase 2

~2700

psychosocial assessment and care

2003

Completed Phase 4

~9920

quality-of-life assessment

2012

Completed Phase 3

~2780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,265 Total Patients Enrolled

202 Trials studying Breast Cancer

80,780 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,310 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,003 Patients Enrolled for Breast Cancer

McMaster UniversityOTHER

880 Previous Clinical Trials

2,597,471 Total Patients Enrolled

13 Trials studying Breast Cancer

2,232 Patients Enrolled for Breast Cancer

Media Library

questionnaire administration Clinical Trial Eligibility Overview. Trial Name: NCT00471601 — N/A

Breast Cancer Research Study Groups: Interviews/Questionnaires

Breast Cancer Clinical Trial 2023: questionnaire administration Highlights & Side Effects. Trial Name: NCT00471601 — N/A

questionnaire administration 2023 Treatment Timeline for Medical Study. Trial Name: NCT00471601 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts still underway for this research project?

"The data displayed on clinicaltrials.gov states that this trail is not actively recruiting, with the initial posting occurring in March 2007 and a last update taking place in October of 2022. Unfortunately, no participants are being accepted at present time; yet 2602 other trials currently have vacancies available for prospective patients."

Answered by AI

Does this research accept elderly participants?

"This medical investigation is seeking participants in the 18-75 age range. There are 74 trials for minors and 2507 clinical trials designed with senior citizens in mind."

Answered by AI

Could I potentially qualify to become involved in this experiment?

"This clinical research is seeking 357 participants who are female and aged between 18-75, all of whom have been diagnosed with breast cancer. Furthermore, the recruited patients must be consulting for a potential reconstruction process."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2007. "Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00471601.