Serial Testing To Assess Cognitive Function In Cancer

NCT06160700 | Terminated DMC

• 1 other identifier: CTO-IUSCCC-0770
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine the effects of immunotherapy on cognitive function of cancer patients and follow them clinically over a period of six months with the Montreal cognitive assessment (MoCA) to assess changes in cognition.

Conditions

Cancer

Keywords

Cancer; Immunotherapy; Cognitive Assessment; Montreal Cognitive Assessment; Chemo Brain

Outcome Measures

Primary Outcomes (1)

• Rate of Cognitive Function Change

  The changes in MoCA scores over 6 months in patients from each group will be plotted and summarized with mean change, standard deviation of change, and standard errors of mean change. The standardized response mean (SRM), calculated as the mean change from baseline to 6 months, divided by the standard deviation of change, will be reported as the main effect size for evaluating the magnitude of change in cognitive function.

  Baseline and 6 months

Secondary Outcomes (1)

• Changes in MoCA scores

  3 and 6 months

Study Arms (3)

Immunotherapy Only

Subjects who are currently receiving immunotherapy only.

Behavioral: Montreal Cognitive Assessment (MoCA)

Chemo-Immunotherapy Control Arm

Subjects who are receiving chemo-immunotherapy.

Behavioral: Montreal Cognitive Assessment (MoCA)

No Active Therapy Control Arm

Subjects who are no currently receiving active therapy.

Behavioral: Montreal Cognitive Assessment (MoCA)

Interventions

Montreal Cognitive Assessment (MoCA) BEHAVIORAL

MoCA is a method for evaluating cognition. This assessment will be conducted at baseline, month 3, and month 6.

Chemo-Immunotherapy Control Arm; Immunotherapy Only; No Active Therapy Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This will be a prospective single site pilot study enrolling subjects with any stage of cancer who are receiving immunotherapy as part of their treatment. Subjects will be recruited from the clinics of the IUSCCC and Eskenazi Health. Subjects will be matched into three groups based on demographics including age, sex and self-reported educational level.

You may qualify if:

• Age ≥ 18 years old
• Ability to provide written informed consent and HIPAA authorization.
• Patients with any type or stage of cancer eligible to begin treatment with immunotherapy alone.
• Note: Prior radiation therapy if not to the brain is acceptable.
• Age ≥ 18 years old
• Ability to provide written informed consent and HIPAA authorization.
• Patients with any stage of cancer eligible to begin treatment with chemoimmunotherapy.
• Note: Prior radiation therapy if not to the brain is acceptable.
• Note: Patients receiving chemotherapy followed by immunotherapy between baseline and the 3 months MoCA will be eligible.
• Age ≥ 18 years old
• Ability to provide written informed consent and HIPAA authorization.
• Patients with a prior history of cancer treated with surgery alone at least 1 year out of treatment OR 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.
• Note: Prior radiation therapy if not to the brain is acceptable.

You may not qualify if:

• Patients who screen positive for depression by PHQ-2 test defined as a score more than 3 will complete the PHQ-9 questionnaire. If they screen positive for depression on the PHQ-9 questionnaire (score of 10 or more) or refuse to complete it, they will be excluded.
• Patients with a history of prior malignancy (excluding skin squamous cell or basal cell cancers).
• Patients with history of brain radiation and brain metastasis.
• Patients with a known prior diagnosis of cognitive dysfunction such as dementia from either Alzheimer's, vascular dementia, Parkinson's, mental retardation, head injury etc. Or any uncontrolled etiologies that can affect cognitive function such as anxiety, depression, bipolar disorder, schizophrenia and hypo/hyperthyroidism will be excluded.
• Note: patients with controlled anxiety/ depression who don't screen positive on the PHQ-2 scale are eligible.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Nasser Hanna, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Associate Division Director of Oncology

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: April 20, 2022
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

US (2)