RECRUITING

A Study of Changes in Thinking Related to Aging and Cancer in Breast Cancer Survivors (TRAC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to look at how differences in cognitive (mental) function develop over time in breast cancer survivors compared to volunteers without a history of cancer (healthy volunteers). Both cancer survivors and healthy volunteers (who are the same age as the cancer survivors) will participate in this study so the researchers can compare the results of neurocognitive testing (which looks at memory, attention, and information processing) on each group of participants.

Official Title

Cognitive Aging in Older Long-term Breast Cancer Survivors

Quick Facts

Study Start:2024-05-10

Study Completion:2028-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06334354

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.

Ages Eligible for Study:65 Years to 80 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Per medical record and/or self-report, identifies as female * Per medical record and/or self-report, currently age 65-80 * Per self-report, has access to a computer and internet connectivity * Score of \<11 on Blessed Orientation-Memory-Concentration Test (BOMC) * As per medical record or self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment. * English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)\\ * Per medical record and/or self-report, history of stage 0-3 breast cancer diagnosed between 50-60 years of age * Per medical record and/or self-report, no evidence of disease (NED) * Per self-report, no history of breast cancer * Language verification: For both survivors and controls, prior to enrollment, all will be asked the following two questions by a CRC to verify English fluency necessary for participation in the study: 1. How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) 2. What is your preferred language for healthcare? (must respond English)	* As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.) * As per medical record or self-report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation * As per medical record or self-report, a diagnosis of a major Axis I psychiatric disorder including Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder. * As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids) * As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for lupus. * As per medical record or self-report, participation in a conflicting (overlapping neurocognitive assessments) research study (i.e. MSK 18-294) * As per medical record or self-report, history of cancer recurrence * As per medical record or self-report, any history of another cancer except nonmelanoma skin cancer or first breast cancer (a secondary breast cancer is exclusionary) * As per medical record or self-report, breast cancer only treated with surgery * As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors * As per medical record or self-report, any history of cancer except non-melanoma skin cancer

Inclusion Criteria

Exclusion Criteria

* Per medical record and/or self-report, identifies as female
* Per medical record and/or self-report, currently age 65-80
* Per self-report, has access to a computer and internet connectivity
* Score of \<11 on Blessed Orientation-Memory-Concentration Test (BOMC)
* As per medical record or self-report, if currently taking psychoactive medications (including but not limited to antidepressants and anxiolytics), dose must have been stable at least two months prior to enrollment.
* English fluent (as per self-report, fluency of "well" or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff)\*\*
* Per medical record and/or self-report, history of stage 0-3 breast cancer diagnosed between 50-60 years of age
* Per medical record and/or self-report, no evidence of disease (NED)
* Per self-report, no history of breast cancer
* Language verification: For both survivors and controls, prior to enrollment, all will be asked the following two questions by a CRC to verify English fluency necessary for participation in the study:
1. How well do you speak English? (must respond "Well" or "Very well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused)
2. What is your preferred language for healthcare? (must respond English)

* As per medical record or self-report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)
* As per medical record or self-report, history of stroke or head injury resulting in a structural lesion on neuropsych imaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation
* As per medical record or self-report, a diagnosis of a major Axis I psychiatric disorder including Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
* As per medical record or self-report, visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
* As per medical record or self-report, use of methotrexate (Amethopterin, Rhematrex, Trexall) or rituximab (Rituxin) for rheumatoid arthritis, psoriasis or Crohn's disease, or cyclophosphamide (Cytoxan, Neosar) for lupus.
* As per medical record or self-report, participation in a conflicting (overlapping neurocognitive assessments) research study (i.e. MSK 18-294)
* As per medical record or self-report, history of cancer recurrence
* As per medical record or self-report, any history of another cancer except nonmelanoma skin cancer or first breast cancer (a secondary breast cancer is exclusionary)
* As per medical record or self-report, breast cancer only treated with surgery
* As per medical record or self-report, history of treatment using radiation, chemotherapy, and/or Tamoxifen or Aromatase-inhibitors
* As per medical record or self-report, any history of cancer except non-melanoma skin cancer

Contacts and Locations

Study Contact

James Root, PhD

CONTACT

646-888-0035

rootj@mskcc.org

Tim Ahles, PhD

CONTACT

646-888-0048

Principal Investigator

James Root, PhD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

James Root, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

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 Registration Dates

Study Start Date2024-05-10

Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-05-10

Study Completion Date2028-08-31

Terms related to this study

Keywords Provided by Researchers

Cognitive aging

Additional Relevant MeSH Terms

Breast Cancer Survivors