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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    465
  • sponsor
    Indiana University
Updated on 27 January 2021

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.

Details
Condition Survival Rate, Endogenous depression, Depression, dyssomnia, Survival, Pain, Acute Pain Service, Sleep Disorders, ANXIETY NEUROSIS, Anxiety, Fatigue, Depression (Major/Severe), Anxiety Disorders (Pediatric), Sleep Disorders (Pediatric), Depression (Adolescent), Depression (Pediatric), Depression (Adult and Geriatric), Depression (Treatment-Resistant), Generalized Anxiety Disorder (GAD), Post-Surgical Pain, Cognitive Impairment, Cognitive Dysfunction, Depressed, Generalized Anxiety Disorder (GAD - Pediatric), Cognitive Impairments, Pain (Pediatric), Anxiety Symptoms, tired, Anxiety Disorders, depressive disorder, sleep disorder, sleep disturbances, fatigued, lack of energy, ache, neurocognitive disturbance, anxiety disorder, depressed mood, miserable, sleep problem, depressive disorders, anxious, sleep disturbance, trouble sleeping, sleep dysfunction, difficulty sleeping, problems with sleeping, disturbed sleep
Treatment Cognitive Dysfunction, Cognitive Dysfunction
Clinical Study IdentifierNCT04611620
SponsorIndiana University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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