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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04611620
Other study ID # NURS-IIR-IUSCCC-0748
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2020
Est. completion date July 27, 2021

Study information

Verified date February 2023
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 682
Est. completion date July 27, 2021
Est. primary completion date May 12, 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
United States Indiana University Indianapolis Indiana

Sponsors (1)

Lead Sponsor Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective Cognitive Dysfunction PROMIS - Cognitive Abilities and Concerns greater than or equal to 6 months post cancer treatment
Secondary Objective Cognitive Dysfunction Visual Episodic Memory greater than or equal to 6 months post cancer treatment
Secondary Objective Cognitive Dysfunction Working Memory greater than or equal to 6 months post cancer treatment
Secondary Objective Cognitive Dysfunction Executive Functioning greater than or equal to 6 months post cancer treatment
Secondary Objective Cognitive Dysfunction Sustained Attention greater than or equal to 6 months post cancer treatment
Secondary Objective Cognitive Dysfunction Visuospatial Working Memory greater than or equal to 6 months post cancer treatment
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