Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients

November 29, 2023 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This multi-center study will include self-referred. This project is a prospective cohort study of 800 women aged 18 and over who are newly diagnosed with breast cancer. Women will be recruited into the study within 6 months after diagnosis and followed for 18 months. The primary purpose of the proposed study is to examine mechanisms that may explain age differences in the health-related quality of life of women who have been diagnosed with a first-time breast cancer. The studies will examine psychosocial factors such as social support, coping strategies, resiliency, and the impact of cancer on life responsibilities as explanations of age-associated factors affecting HRQL. This project is an observational, longitudinal study of women aged 18 and over who are newly diagnosed with breast cancer. In order to examine both the short- and longer-term impact of breast cancer on HRQL, the study will survey women post diagnosis and follow them at 3, 6, 12, and 18 months. A secondary purpose is to have this large cohort of breast cancer patients serve as a comparison group for other studies in the Behavioral Center of Excellence award given to Wake Forest Medical Center by the Department of Defense. Extensive baseline data will be collected by an in-depth chart review and interview for additional data. Information will be gathered on demographics, clinical and treatment variables. The study intervention consists of collecting data on health-related quality of life through specific questionnaires.

Data collection instruments will be mailed to participants at regularly scheduled intervals accompanied by a stamped,addressed envelope. If the participant does not return study forms within three weeks, the participant will be called.

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

First time breast cancer patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
women with breast cancer
Behavioral: questionnaires
Participants will be followed regularly at 3, 6, 12, and 18-month intervals
Other Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The study measurements are quality of life questionnaires
Time Frame: 7 years 2 months
7 years 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

University of Texas Southwestern Medical Center
Wake Forest University

Investigators

  • Principal Investigator: Kimberly Van Zee, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimated)

December 28, 2007

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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