Clinical trial NCT04611620: Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
Official title: Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survivorship
Cognitive Dysfunction
Pain
Depression
Anxiety
Fatigue
Sleep Disturbance
Keywords: Breast Cancer and Colorectal Cancer
Co-Occurring Symptoms
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 682
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
Secondary outcomes:
measure: Objective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
measure: Objective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
measure: Objective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
measure: Objective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
measure: Objective Cognitive Dysfunction
timeFrame: greater than or equal to 6 months post cancer treatment
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: IU
name: Diane Von Ah, PhD
role: PRINCIPAL_INVESTIGATOR
References: