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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04611620
Enrollment
682
Registered
2020-11-02
Start date
2020-11-16
Completion date
2021-07-27
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Cognitive Dysfunction, Depression, Fatigue, Pain, Sleep Disturbance, Survivorship

Keywords

Breast Cancer and Colorectal Cancer, Co-Occurring Symptoms

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.

Interventions

BEHAVIORALCognitive 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.

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective Cognitive Dysfunctiongreater than or equal to 6 months post cancer treatmentPROMIS - Cognitive Abilities and Concerns

Secondary

MeasureTime frameDescription
Objective Cognitive Dysfunctiongreater than or equal to 6 months post cancer treatmentVisual Episodic Memory

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026