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

February 21, 2023 updated by: Diane Von Ah, Indiana University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

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.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 465 breast and colorectal cancer patients will be recruited for this study. Breast and colorectal cancer survivors.

The eligibility checklist is a self-report questionnaire. Participants will be asked to self-identify that they are 21 years of age or older, had been diagnosed with breast or colorectal cancer excluding Stage IV (those without distant metastasis) and have completed treatment (adjuvant or neo-adjuvant) at least 6 months prior to completing the survey. In addition, as part of the eligibility checklist, participants will need to self-rate that they have cognitive concerns (select yes).

Description

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 (Stage I-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:

  1. Male or female CRC survivors
  2. Ability to provide written consent and HIPAA authorization
  3. ≥ 21 years of age and older
  4. ≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC
  5. Identify cognitive concerns (select yes)

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer and Colorectal Cancer Survivors
The purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors.
Behavioral: Cognitive Dysfunction
To fully characterize factors associated with cognitive dysfunction in BCS and CRC survivors that have cognitive concerns and (2) to fully characterize factors associated with psychoneurological symptom cluster in BCS and CRC survivors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
PROMIS - Cognitive Abilities and Concerns
greater than or equal to 6 months post cancer treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
Visual Episodic Memory
greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
Working Memory
greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
Executive Functioning
greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
Sustained Attention
greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Time Frame: greater than or equal to 6 months post cancer treatment
Visuospatial Working Memory
greater than or equal to 6 months post cancer treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Diane Von Ah, PhD, IU

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 Major Dates

Study Start (Actual)

November 16, 2020

Primary Completion (Actual)

May 12, 2021

Study Completion (Actual)

July 27, 2021

Study Registration Dates

First Submitted

October 12, 2020

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NURS-IIR-IUSCCC-0748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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