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OpenTrials
Completed

NCT Number: NCT04611620

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Dysfunction

Behavioral

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.

Primary outcomes

  1. Subjective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    PROMIS - Cognitive Abilities and Concerns

Secondary outcomes

  1. Objective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    Visual Episodic Memory

  2. Objective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    Working Memory

  3. Objective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    Executive Functioning

  4. Objective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    Sustained Attention

  5. Objective Cognitive Dysfunction

    Time frame: greater than or equal to 6 months post cancer treatment

    Visuospatial Working Memory

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2020
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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