RECRUITING

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

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Conditions

Neoplasm, ColorectalCognitive ImpairmentCognitive DysfunctionCognitive ChangeChemo-brainChemo FogChemotherapy EffectCognitive DeclinePalliative CarePalliative OncologySupportive CareSupportive OncologyChemo Brain

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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

The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

Official Title

Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Quick Facts

Study Start:2021-09-20
Study Completion:2030-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05014399

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 CriteriaExclusion Criteria
  1. * Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry.
  2. * A histologically-confirmed colorectal tumor
  3. * Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible.
  4. * Patients must not have received cytotoxic chemotherapy previous to enrollment.
  1. * Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
  2. * Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys
  3. * Pregnant or breastfeeding
  4. * Any known brain metastases
  5. * Non-English speaking patients
  6. * Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease.
  7. * Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.

Contacts and Locations

Study Contact

Joseph McCollom, DO
CONTACT
260-266-7100
joseph.mccollom@parkview.com
Emily Powell, PHD
CONTACT
emily.powell@parkview.com

Principal Investigator

Joseph McCollom, DO
PRINCIPAL_INVESTIGATOR
Parkview Health

Study Locations (Sites)

Parkview Cancer Institute
Fort Wayne, Indiana, 46845
United States

Collaborators and Investigators

Sponsor: Joseph McCollom

  • Joseph McCollom, DO, PRINCIPAL_INVESTIGATOR, Parkview Health

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 Date2021-09-20
Study Completion Date2030-10

Study Record Updates

Study Start Date2021-09-20
Study Completion Date2030-10

Terms related to this study

Keywords Provided by Researchers

  • Palliative Care
  • Palliative Oncology
  • Supportive Care
  • Supportive Oncology
  • Cognitive Impairment
  • Chemo Brain

Additional Relevant MeSH Terms

  • Neoplasm, Colorectal
  • Cognitive Impairment
  • Cognitive Dysfunction
  • Cognitive Change
  • Chemo-brain
  • Chemo Fog
  • Chemotherapy Effect
  • Cognitive Decline