Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms

Last updated: February 21, 2023
Sponsor: Indiana University
Overall Status: Completed

Phase

N/A

Condition

Narcolepsy

Mental Disability

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT04611620
NURS-IIR-IUSCCC-0748
  • Ages > 21
  • All Genders

Study Summary

This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion Criteria for Breast cancer survivors:

  1. Female BCS
  2. ≥ 21 years of age and older
  3. Ability to provide written consent and HIPAA authorization
  4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (StageI-IIIA) breast cancer. Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
  5. Identify cognitive concerns (select yes) Inclusion Criteria for Colorectal cancer survivors:
  6. Male or female CRC survivors
  7. Ability to provide written consent and HIPAA authorization
  8. ≥ 21 years of age and older
  9. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III)CRC
  10. Identify cognitive concerns (select yes)

Exclusion

Exclusion Criteria:

  1. Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
  2. Unable to read and understand English to complete survey questionnaires.

Study Design

Total Participants: 682
Study Start date:
November 16, 2020
Estimated Completion Date:
July 27, 2021

Study Description

Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.

Secondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.

Connect with a study center

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

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