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

Completed

• Conditions: Survivorship; Sleep Disturbance; Depression; Cognitive Dysfunction; Pain; Anxiety; Fatigue
• Interventions: Behavioral: Cognitive Dysfunction

• Registration Number: NCT04611620
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2020-10-12
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2020-11-16
• Primary Completion: 2021-05-12
• Study Completion: 2021-07-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast Cancer and Colorectal Cancer Survivors	Cognitive Dysfunction	The purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors.

Primary Outcome Measures

Name	Time	Method
Subjective Cognitive Dysfunction	greater than or equal to 6 months post cancer treatment	PROMIS - Cognitive Abilities and Concerns

Secondary Outcome Measures

Name	Time	Method
Objective Cognitive Dysfunction	greater than or equal to 6 months post cancer treatment	Visuospatial Working Memory

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States