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

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04611620

Collaborator

(none)

465

Enrollment

Location

35.5

Anticipated Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Survivorship Cognitive Dysfunction Pain Depression Anxiety Fatigue Sleep Disturbance	Behavioral: Cognitive Dysfunction

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 Design

Study Type:

Observational

Anticipated Enrollment :

465 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Subjective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
PROMIS - Cognitive Abilities and Concerns

Secondary Outcome Measures

Objective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
Visual Episodic Memory
Objective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
Working Memory
Objective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
Executive Functioning
Objective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
Sustained Attention
Objective Cognitive Dysfunction [greater than or equal to 6 months post cancer treatment]
Visuospatial Working Memory

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Inclusion Criteria for Breast cancer survivors:

Female BCS
≥ 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
≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC
Identify cognitive concerns (select yes)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University

Investigators

Principal Investigator: Diane Von Ah, PhD, IU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Diane Von Ah, Associate Dean of Academic Operations, Indiana University

ClinicalTrials.gov Identifier:

NCT04611620

Other Study ID Numbers:

NURS-IIR-IUSCCC-0748

First Posted:

Nov 2, 2020

Last Update Posted:

Dec 10, 2020

Last Verified:

Dec 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Diane Von Ah, Associate Dean of Academic Operations, Indiana University

Breast Cancer and Colorectal Cancer

Co-Occurring Symptoms

Additional relevant MeSH terms:

Dyssomnias

Parasomnias

Cognitive Dysfunction

Study Results

No Results Posted as of Dec 10, 2020