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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00582478
Collaborator
University of Texas Southwestern Medical Center (Other), Wake Forest University (Other)
650
Enrollment
1
Location
254
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: questionnaires

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 Design

Study Type:
Observational
Anticipated Enrollment :
650 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
Study Start Date :
Oct 1, 2001
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm 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).

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The study measurements are quality of life questionnaires [7 years 2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center
    • University of Texas Southwestern Medical Center
    • Wake Forest University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00582478
    Other Study ID Numbers:
    • 01-120
    First Posted:
    Dec 28, 2007
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Keywords provided by Memorial Sloan Kettering Cancer Center
    Breast cancer
    Quality of Life
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 6, 2021