RECRUITING

Cognitive Dysfunction in Chronic and Persistent Immune Thrombocytopenia

Conditions

Immune Thrombocytopenia Cognitive impairment ITP Quality of life Cognitive dysfunction Cognition

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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

Individuals with immune thrombocytopenia (ITP) frequently report difficulties with attention and memory. The main question this study seeks to answer is: Do patients with ITP have evidence of cognitive impairment as detected by a cognitive function test battery? To address this issue, participants will take a cognitive function test and complete surveys on quality of life, fatigue, depression, and cognitive symptoms. The primary aim of the study is to evaluate for the presence and extent of cognitive impairment in patients with ITP. The study will also assess whether cognitive impairment in ITP is associated with patient-reported impacts on quality of life, fatigue, mood, and cognitive symptoms as well as clinical characteristics such as ITP disease and treatment history.

Official Title

Prevalence, Reproducibility, and Feasibility of Longitudinal Assessment of Neurocognitive Dysfunction in Adults with Chronic and Persistent Immune Thrombocytopenia (COGFIT)

Quick Facts

Study Start:2024-09-15

Study Completion:2028-09-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06817395

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:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Adults aged ≥ 18 years * A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \<50 x 109/L on two occasions in the preceding 3 to 12 months or \>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator. * Ability to follow instructions in English.	* Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease. * Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse. * Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer. * Brain tumor or cranial surgery within the past year. * Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.

Inclusion Criteria

Exclusion Criteria

* Adults aged ≥ 18 years
* A clinical diagnosis of persistent or chronic ITP, as defined by a history of platelet counts \<50 x 109/L on two occasions in the preceding 3 to 12 months or \>12 months, respectively, and documented response to at least 1 prior ITP-directed therapy. ITP-directed therapies include corticosteroids, intravenous immune globulin, Rho(D) immune globulin, splenectomy, thrombopoietin receptor agonists, and fostamatinib. Other qualifying agents used for the treatment of ITP are permissible with approval of the principal investigator.
* Ability to follow instructions in English.

* Pre-existing diagnosis of cognitive impairment from dementia, stroke, or other neurologic disease.
* Active psychiatric disorder, defined as uncontrolled major depression, schizophrenia, severe anxiety, or active alcohol or drug abuse.
* Active malignancy, requiring or likely to require chemotherapeutic or surgical treatment, except for non-melanoma skin cancer.
* Brain tumor or cranial surgery within the past year.
* Significant hearing or vision impairment that would preclude the ability to complete neurocognitive testing via a virtual platform.

Contacts and Locations

Study Contact

Debbie Jiang, MD

CONTACT

617-724-4000

dcjiang@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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 Date2024-09-15

Study Completion Date2028-09-15

Study Record Updates

Study Start Date2024-09-15

Study Completion Date2028-09-15

Terms related to this study

Keywords Provided by Researchers

Cognitive impairment
Immune thrombocytopenia
ITP
Quality of life
Cognitive dysfunction
Cognition

Additional Relevant MeSH Terms

Immune Thrombocytopenia