NCT00582478

Brief Summary

The purpose of this study is to look at how breast cancer treatment affects quality of life in women of different ages. The U.S. Army Breast Cancer Research Program funds this study. In this research project, we wish to study a woman's quality of life after breast cancer treatment as related to her health. We want to know how you feel about your quality of life.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Oct 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress98%
Oct 2001Dec 2026

Study Start

First participant enrolled

October 1, 2001

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
18.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

25.2 years

First QC Date

December 21, 2007

Last Update Submit

January 5, 2026

Conditions

Breast Cancer

Keywords

Breast cancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • The study measurements are quality of life questionnaires

    7 years 2 months

Study Arms (1)

1

women with breast cancer

Behavioral: questionnaires

Interventions

questionnairesBEHAVIORAL

Participants will be followed regularly at 3, 6, 12, and 18-month intervals

Also known as: Functional Assessment of Cancer Therapy - Fact B, 2. Beck Depression Inventory, 3. MOS Sexual Functioning, Questionnaire, 4. Body Appearance Scale, 5. SF-36 Health Status Questionnaire, 6., Global Quality of Life, 7. Interval Medical and Reproductive History, 8. Physical, Symptoms Checklist, 9. RAND Social Support Scale, 10. Funtional Assessment of, Chronic Illness Therapy-Spiritual Well Being (FACIT-Sp) 11.Optimisim, 12 Brief COPE, Scale, 13. Illness Intrusive Scale, 14. Posttraumatic Growth Inventory (PTGI), 15., Quality of Life in Adult Cancer Survivors (QLACS).
1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

First time breast cancer patients

You may qualify if:

  • Female
  • Aged 18 or older at the time of breast cancer diagnosis
  • English-speaking
  • Community dwelling (i.e. not living in a residential care or correctional facility)
  • Diagnosed with invasive breast cancer Stage I, II, or III within the previous 6 months
  • First time diagnosis
  • Have physician agreement for participation
  • Provide informed consent

You may not qualify if:

  • Psychiatric or psychological abnormality precluding informed consent or ability to complete questionnaires
  • Previous or concurrent malignancy (except basal and squamous skin cancer and stage 0 cervical cancer)
  • Stage IV breast malignancy
  • Residency outside of the United States
  • For women ages 45 years and younger only: Those participants \< 45 years who were having regular menstrual cycles at the time of diagnosis will be excluded from this protocol. This study will only be enrolling women in this age category who have had a prior hysterectomy or were having irregular menstrual cycles at the time of diagnosis. Women with regular menstrual cycles will be enrolled into a companion project (i.e., Menstrual Cycle Maintenance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and QuestionnairesReproductive HistoryWeights and Measuresprostacyclin synthetaseQuality of Life

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthMedical History TakingDiagnostic Techniques and ProceduresDiagnosisEpidemiologic FactorsHealth StatusDemographyEpidemiologic Measurements

Study Officials

  • Tracy-Ann Moo, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 28, 2007

Study Start

October 1, 2001

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations

US(1)