An observational study in Survivorship, Cognitive Dysfunction and Pain, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-02-22.
Sponsored by Indiana University · Observational
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.
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 682 is above the median of 150 across 950 observational studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 465 breast and colorectal cancer patients will be recruited for this study. Breast and colorectal cancer survivors.
The eligibility checklist is a self-report questionnaire. Participants will be asked to self-identify that they are 21 years of age or older, had been diagnosed with breast or colorectal cancer excluding Stage IV (those without distant metastasis) and have completed treatment (adjuvant or neo-adjuvant) at least 6 months prior to completing the survey. In addition, as part of the eligibility checklist, participants will need to self-rate that they have cognitive concerns (select yes).
Inclusion Criteria:
Inclusion Criteria for Breast cancer survivors:
≥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.
Inclusion Criteria for Colorectal cancer survivors:
Exclusion Criteria:
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.
Subjective Cognitive Dysfunction
PROMIS - Cognitive Abilities and Concerns
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Visual Episodic Memory
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Working Memory
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Executive Functioning
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Sustained Attention
Time frame: greater than or equal to 6 months post cancer treatment
Objective Cognitive Dysfunction
Visuospatial Working Memory
Time frame: greater than or equal to 6 months post cancer treatment
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Indiana University