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

Indiana University

Status: Completed

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

Treatments: Behavioral: Cognitive Dysfunction

Study type: Observational

Funder types: Other

Identifiers

NCT04611620

NURS-IIR-IUSCCC-0748

Details and patient eligibility

About

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.

Full 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.

Enrollment: 682 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

682 participants in 1 patient group

Breast Cancer and Colorectal Cancer Survivors

Description:

The purpose of this study is to explore the factors related with cognitive concerns and other symptoms in breast and colorectal cancer survivors.

Treatment:

Behavioral: Cognitive Dysfunction