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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age60-80
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Per medical record and/or self-report, identifies as female

Per medical record and/or self-report, currently age 60-80

Per self-report, has access to a computer and internet connectivity

Score of <11 on Blessed Orientation-Memory-Concentration Test (BOMC)

Disqualifiers

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)

Trial population

Survivors will be recruited in Breast Medicine Service clinics at the Breast and Imaging Center (BAIC) after having been identified via a Dataline query and/or weekly clinic schedules or through direct referrals from a member of the patient's treatment team.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Assessments

    Other intervention

    Sociodemographics, Deficit Accumulation Questionnaires, Remote Cognitive Assessment, Deficit Accumulation Questionnaires,Remote Cognitive Assessment

  • Assessment (Survivors Only)

    Other intervention

    \*Tumor/Treatment Variables (Survivors Only)

  • APOE and DNA Isolation

    Other intervention

    Biospecimens procurement and processing

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: Breast Cancer Survivor (BCS)3 interventions
Group B: Non-cancer Control (NCC)2 interventions

Trial outcomes

Primary outcomes

1

examine cognitive effects

of remote cancer diagnosis and treatment and potential association with increased/accelerated deficit accumulation in older survivors.The primary outcome is cognitive performance, as measured by CogSuite aggregate intra-individual variability, the average intra-individual variability across the subtests. Cognition will be assessed using the CogSuite battery of five subtests: 1) Attention Network Test; 2) Mental Rotation; 3) Stop Signal Delay; 4) N-back; and 5) Psychomotor Speed measures.

Time frame
within 45 days of participant consent

Secondary outcomes

1

measure levels of smoking exposure

by testing cotinine (an important metabolite of nicotine) in urine samples to examine possible interactions of smoking history with genetic variants, e.g., APOE ε4+, on cognition

Time frame
within 45 days of participant consent

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.