Serial Testing To Assess Cognitive Function In Patients With Cancer Being Treated With Immunotherapy

N
Nasser Hanna, MD

Primary Investigator

Overview

The purpose of this study is to find out if using the Montreal Cognitive Assessment can help doctors detect potential cognitive decline in people being treated for lung cancer with immunotherapy. 

Description

Who is Eligible:
Inclusion Criteria for immunotherapy only group:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with any type or stage of cancer eligible to begin treatment with immunotherapy alone. 
 
Inclusion Criteria for chemotherapy plus immunotherapy control arm:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with any stage of cancer eligible to begin treatment with chemo-immunotherapy 
 
Inclusion Criteria for patients not on active treatment control arm:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with a prior history of cancer treated with surgery alone at least 1 year out of treatment  surgery and neo-adjuvant/adjuvant                  chemotherapy who are at least 2 years out from treatment. If patients underwent any other form of treatment for their current malignancy,          they will be excluded. 
 
Exclusion Criteria for all arms:
1. Patients who screen positive for depression (by PHQ-2 test) will be excluded.
2. Patients with history of prior malignancy, brain radiation and brain metastasis will also be excluded. 
3. Patients with a history of previous malignancy diagnosis. 
4. Patients with a known prior diagnosis of cognitive dysfunction, dementia from either Alzheimer’s, vascular or any other etiology like                      Parkinson’s, mental retardation, head injury, bipolar disorder, schizophrenia and hypothyroidism will be excluded.
 
What is Involved:
Will first answer some demographic questions questions (i.e. age, gender, education level, etc.) and questions about how you have been feeling.(this will take about 5 minutes)
You will then be asked to complete a questionnaire called the Montreal Cognitive Assessment Method (MoCA) at the following timepoints: before you start treatment, after 3 months of treatment, and after 6 months of treatment. The MoCA has questions regarding your ability to process and understand visual information about where objects are, language, short term memory recall, concentration, working memory and awareness of time and place. (this will take about 15 minutes) 
We expect your overall participation in this study to last up to seven months.
 
Compensation:
You will be given a one-time $25 Target gift card when you are enrolled into this study. 

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria:
Inclusion Criteria for immunotherapy only group:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with any type or stage of cancer eligible to begin treatment with immunotherapy alone. 
 
Inclusion Criteria for chemotherapy plus immunotherapy control arm:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with any stage of cancer eligible to begin treatment with chemo-immunotherapy 
 
Inclusion Criteria for patients not on active treatment control arm:
1. Age ≥ 18 years old 
2. Ability to provide written informed consent and HIPAA authorization. 
3. Patients with a prior history of cancer treated with surgery alone at least 1 year out of treatment  surgery and neo-adjuvant/adjuvant                  chemotherapy who are at least 2 years out from treatment. If patients underwent any other form of treatment for their current malignancy,          they will be excluded. 
 
Exclusion Criteria:
Exclusion Criteria for all arms:
1. Patients who screen positive for depression (by PHQ-2 test) will be excluded.
2. Patients with history of prior malignancy, brain radiation and brain metastasis will also be excluded. 
3. Patients with a history of previous malignancy diagnosis. 
4. Patients with a known prior diagnosis of cognitive dysfunction, dementia from either Alzheimer’s, vascular or any other etiology like                      Parkinson’s, mental retardation, head injury, bipolar disorder, schizophrenia and hypothyroidism will be excluded.
 
 

Updated on 08 Feb 2024. Study ID: 14071

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