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Trial record 1 of 198 for:    "Virginia Cancer Specialists" | United States
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Older Breast Cancer Patients: Risk for Cognitive Decline (TLC)

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ClinicalTrials.gov Identifier: NCT03451383
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
Memorial Sloan Kettering Cancer Center
Indiana University
H. Lee Moffitt Cancer Center and Research Institute
City of Hope Medical Center
Hackensack Meridian Health
Information provided by (Responsible Party):
Jeanne Mandelblatt, Georgetown University

Brief Summary:
The goal of this study is to evaluate the impact of systemic therapy on cognition in older breast cancer patients, explore which domains are most affected, measure associations between cognitive decline and QOL, and describe how APOE and COMT polymorphisms, inflammatory biomarkers and physical activity moderate cognitive outcomes. This study is being done nationally, with recruiting sites at Georgetown University, Montgomery General Hospital, Virginia Cancer Specialists, Memorial Sloan-Kettering, Moffitt Cancer Center, City of Hope National Medical Center, Hackensack University Medical Center, Indiana University and University of California, Los Angeles.

Condition or disease
Cancer, Breast Age-related Cognitive Decline Cognitive Decline

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Older Breast Cancer Patients: Risk for Cognitive Decline. The Thinking and Living With Cancer (TLC) Study
Actual Study Start Date : August 1, 2010
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Breast Cancer Case
Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3.
Non-Cancer Controls
Women age 60+ with no diagnosis of breast cancer.



Primary Outcome Measures :
  1. Change in Attention [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: NAB Digits Forward and Backward

  2. Change in Processing Speed [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Trailmaking A and B

  3. Change in Processing Speed [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Digit Symbol Subtest - Wechsler Adult Intelligence Test-III

  4. Change in Processing Speed [ Time Frame: Baseline and annually up to 5 years ]
    Using assessment: The Timed Instrumental Activities of Daily Living

  5. Change in Executive Function [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Trailmaking A and B

  6. Change in Executive Function [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Digit Symbol Subtest - Wechsler Adult Intelligence Test-III

  7. Change in Executive Function [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Controlled Oral Word Association Test

  8. Change in Executive Function [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: NAB Driving Scenes

  9. Change in Executive Function [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: NAB Figure Drawing

  10. Change in Learning [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: Logical Memory I and II (Wechsler Memory Scale)

  11. Change in Learning [ Time Frame: Baseline and annually up to 5 years ]
    Using neuropsychological test: NAB List Learning


Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: Baseline and annually up to 5 years ]
    Using Functional Assessment of Cancer Therapy-Breast quality of life measure (FACT-B)

  2. Change in Quality of Life [ Time Frame: Baseline and annually up to 5 years ]
    Using Medical Outcome Study measure (MOS)

  3. Change in Quality of Life [ Time Frame: Baseline and annually up to 5 years ]
    Using Short Form Health Survey measure (SF-12)

  4. Change in cancer-related symptoms (including fatigue, sleep, pain, anxiety and depression) [ Time Frame: Baseline and annually up to 5 years ]
    Using survey data

  5. Biomarkers of aging (genotype, inflammatory biomarkers, telomere length, p16, miRNA) [ Time Frame: Baseline and annually up to 5 years ]
    Using annual biospecimen collection of blood or saliva

  6. Change in physical activity [ Time Frame: Baseline and annually up to 5 years ]
    Using self-report

  7. Change in physical activity [ Time Frame: Baseline and annually up to 5 years ]
    Using actigraphy


Biospecimen Retention:   Samples With DNA
A total of up to 27ml of blood or up to 2ml of saliva will be collected at each time point by trained staff for APOE and COMT DNA testing, inflammatory biomarkers and for storage of DNA for future tests. 2-3 6mL lavender top vacutainer tubes containing ethylenediamine tetraaceticacid (EDTA) will be used for DNA extraction, biobanking and inflammatory biomarkers. 1 4ml CPT tube will be collected for biobanking. Up to 2 2.5ml PAXgene tubes will be collected for future DNA and RNA research.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female breast cancer cases and female matched non-cancer controls
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women age 60+ with a newly diagnosed breast adenocarcinoma staged 0-3 and matched controls.
Criteria

Inclusion Criteria:

For cancer patients, eligibility includes:

  • being female
  • Age 60+ at diagnosis of a new primary histological confirmed adenocarcinoma breast cancer
  • AJCC stages 0-3 or planning neoadjuvant therapy
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.
  • Participant report of no previous or current chemotherapy or hormonal treatment use (anastrazole, exemestane, etc.) This does not include hormonal replacement therapy, synthetic thyroid hormones, etc.

For controls, eligibility includes:

  • being female
  • Age 60+
  • In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
  • If currently taking psychoactive medications (including, but not limited to anticonvulsants, antidepressants, and anxiolytics), dose must have been stable at least two months prior to enrollment.

Exclusion:

We apply the same exclusion criteria for patients and controls.

  • Participant report of a history of formal diagnosis of neurological problems (i.e. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, brain tumors, etc.)
  • Participant report of surgery on the brain for any reason (cancerous or non-cancerous tumors, subdural hematomas, AV malformations, increased intracranial pressure, etc.)
  • Participant report of a history of stroke (with the exception of TIA if ≥1 year ago)
  • Participant report of HIV/AIDS
  • Participant report of moderate to severe head trauma (loss of consciousness > 60 min or with evidence of structural brain changes on imaging)
  • History of major psychiatric disorder (DSM-IV Axis 1) (i.e. major depressive disorder (untreated or poorly treated), bipolar disorders, schizophrenia, or substance abuse disorders (self-reported and/or stated in medical record).
  • Participant report of a history of prior breast or other cancer with the exception of non-melanoma skin cancer. An exception for cases only: women who completed treatment for a previous cancer at least 5 years ago and have not undergone any chemotherapy or hormonal therapy. This previous cancer cannot be breast cancer.
  • Participant report of previous or current chemotherapy or hormonal therapy use
  • Participant use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for Lupus.
  • Visual or hearing impairment that would preclude ability to complete interviews or neuropsychological testing, such as significant macular degeneration or being unable to correct hearing with hearing aides
  • Non-English speaking
  • To participate in the optional neuroimaging portion of the study:

Participant cannot be claustrophobic Participant cannot have a pacemaker, aneurysm clip or other implants that are not MRI safe Participant cannot have any type of implanted electrical device


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451383


Contacts
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Contact: Jeanne Mandelblatt 2026870801 mandelbj@georgetown.edu
Contact: Meghan Mihalache 2026878247 mem323@georgetown.edu

Locations
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United States, District of Columbia
Georgetown University Recruiting
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Memorial Sloan Kettering Cancer Center
Indiana University
H. Lee Moffitt Cancer Center and Research Institute
City of Hope Medical Center
Hackensack Meridian Health
  Study Documents (Full-Text)

Documents provided by Jeanne Mandelblatt, Georgetown University:

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Responsible Party: Jeanne Mandelblatt, Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT03451383     History of Changes
Other Study ID Numbers: 2008-363
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeanne Mandelblatt, Georgetown University:
breast cancer
cognitive decline

Additional relevant MeSH terms:
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Breast Neoplasms
Cognitive Dysfunction
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders