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Clinical Trials/NCT04611620
NCT04611620
Completed
Not Applicable

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

Indiana University1 site in 1 country682 target enrollmentNovember 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Survivorship
Sponsor
Indiana University
Enrollment
682
Locations
1
Primary Endpoint
Subjective Cognitive Dysfunction
Status
Completed
Last Updated
3 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
November 16, 2020
End Date
July 27, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Diane Von Ah

Associate Dean of Academic Operations

Indiana University

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria for Breast cancer survivors:
  • ≥ 21 years of age and older
  • Ability to provide written consent and HIPAA authorization
  • ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.
  • Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
  • Identify cognitive concerns (select yes)
  • Inclusion Criteria for Colorectal cancer survivors:
  • Male or female CRC survivors
  • Ability to provide written consent and HIPAA authorization
  • ≥ 21 years of age and older

Exclusion Criteria

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

Outcomes

Primary Outcomes

Subjective Cognitive Dysfunction

Time Frame: greater than or equal to 6 months post cancer treatment

PROMIS - Cognitive Abilities and Concerns

Secondary Outcomes

  • Objective Cognitive Dysfunction(greater than or equal to 6 months post cancer treatment)

Study Sites (1)

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