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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00582478
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : October 4, 2019
Sponsor:
Collaborators:
University of Texas Southwestern Medical Center
Wake Forest University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date December 21, 2007
First Posted Date December 28, 2007
Last Update Posted Date October 4, 2019
Study Start Date October 2001
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2007)
The study measurements are quality of life questionnaires [ Time Frame: 7 years 2 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
Official Title Investigating Mechanisms to Explain Age Associated Differences in Quality of Life Among Breast Cancer Patients
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population First time breast cancer patients
Condition Breast Cancer
Intervention 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).
Study Groups/Cohorts 1
women with breast cancer
Intervention: Behavioral: questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: December 21, 2007)
650
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00582478
Other Study ID Numbers 01-120
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
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
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date October 2019