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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The study measurements are quality of life questionnaires

Outcome Time Frame:

7 years 2 months

Safety Issue:


Principal Investigator

Kimberly Van Zee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Quality of Life
  • Breast Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021