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RecruitingPhase not listed

Impact of Targeted Therapy on Cancer-Related Cognitive Impairment

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "GROUP I: TKI recipients complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study."
  • "GROUP II: Cancer-free individuals complete surveys, undergo cognitive assessments, undergo saliva sample collection, and have their medical records reviewed on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares brain health and well-being in adults taking targeted cancer drugs called TKIs with adults who are cancer-free. It is for adults starting TKI treatment for CML or CLL, two types of blood cancer, and cancer-free adults of a similar age and the same sex.

This study examines whether there are differences in brain health or well-being in patients receiving TKI therapy for leukemia compared to individuals who do not receive TKI therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Everyone must be age 18 or older.
  • Everyone must be able to speak and read English.
  • Everyone must understand and be willing to sign a form agreeing to join the study.
  • People in the TKI group must have CML or CLL.
  • People in the TKI group must be due to take their first dose within 30 days or have taken their first dose in the past 30 days.
  • People in the comparison group must be cancer-free and matched to someone in the TKI group by sex and age, within 5 years.

Who can't join

  • A history of cancer that spread to other parts of the body, a tumor that started in the brain, or radiation treatment to the brain.
  • A history of TKI treatment.
  • In the past 5 years: cell-killing chemotherapy, immune checkpoint drugs (which help the immune system fight cancer), hormone therapy, biologic therapy (treatments using substances from living things), or radiation. Exceptions are prior hydroxyurea for CML or CLL, and obinutuzumab or rituximab given with TKIs for CLL.
  • A stroke in the past year, lasting thinking problems from an earlier stroke, or a head injury that caused passing out in the year before signing the consent form.
  • Dementia or a severe disease that damages the brain or nerves and makes daily tasks difficult.
  • A mental health condition that required a hospital stay in the past year.
  • Being pregnant now or reporting that you are colorblind.
  • Being a study staff member who has already seen or given the study's thinking and memory tests.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * TKI RECIPIENTS: Participants must have a diagnosis of CML or CLL * TKI RECIPIENTS: Participants must be scheduled to receive their first dose of TKI therapy for CML or CLL within 30 days or have received their first dose of TKI therapy for CML or CLL within the previous 30 days * TKI RECIPIENTS: Participants must be ≥ 18 years of age * TKI RECIPIENTS: Participants must be able to speak and read English * TKI RECIPIENTS: Participants must be able to understand and willing to sign an informed consent document * CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be ≥ 18 years of age * CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to speak and read English * CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Participants must be able to understand and willing to sign an informed consent document * CANCER-FREE INDIVIDUALS SERVING AS CONTROLS: Each participant must be matched to a TKI recipient participant based on sex and age ±5 years (i.e., must be no more than 5 years older or younger than the TKI recipient participant) Exclusion Criteria: * Participants must have no history of metastatic cancer, primary brain tumor, or brain irradiation * Participants must have no history of TKI therapy * Participants must have no history of cytotoxic chemotherapy, immune checkpoint inhibitor therapy, hormonal therapy, biologic therapy, radiotherapy within the past 5 years. However, permitted treatments include prior use of hydroxyurea for the treatment of CML or CLL as well as treatment with obinutuzumab or rituximab concurrent with TKI therapy for CLL * Participants must have no history of stroke within the past year and no remaining cognitive symptoms from any stroke prior to the past year * Participants must have no history of head trauma with loss of consciousness within the year prior to consent * Participants must have no diagnosis of dementia or severe neurodegenerative disease impairing daily functioning * Participants must have no psychiatric condition that led to hospitalization within the past year * Participants must not be currently pregnant * Participants must not be colorblind based on self-report * Participants must not be study staff who have previously viewed or administered the objective cognitive function measures (e.g., CANTAB)

Study sites (1)

NY