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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611620
• Other study ID #: NURS-IIR-IUSCCC-0748
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Cognitive Dysfunction
• Depression
• Dyssomnias
• Fatigue
• Pain
• Parasomnias
• Sleep Disturbance
• Survivorship

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