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

NCT04611620 | Completed DMC

• 1 other identifier: NURS-IIR-IUSCCC-0748
• Study Type: observational
• Target: 682
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast Cancer and Colorectal Cancer; Co-Occurring Symptoms

Outcome Measures

Primary Outcomes (1)

• Subjective Cognitive Dysfunction

  PROMIS - Cognitive Abilities and Concerns

  greater than or equal to 6 months post cancer treatment

Secondary Outcomes (5)

• Objective Cognitive Dysfunction

  greater than or equal to 6 months post cancer treatment

• Objective Cognitive Dysfunction

  greater than or equal to 6 months post cancer treatment

• Objective Cognitive Dysfunction

  greater than or equal to 6 months post cancer treatment

• Objective Cognitive Dysfunction

  greater than or equal to 6 months post cancer treatment

• Objective Cognitive Dysfunction

  greater than or equal to 6 months post cancer treatment

Study Arms (1)

Breast Cancer and Colorectal Cancer Survivors

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

Interventions

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.

Breast Cancer and Colorectal Cancer Survivors

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)
• 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)

You may not qualify if:

• Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
• Unable to read and understand English to complete survey questionnaires.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (2)

• Goto T, Saligan LN, Li X, Xiang L, Kwiat C, Nguyen C, Crouch A, Von Ah D. Associations of brain-derived neurotrophic factor rs6265 polymorphism and cognitive function in breast cancer survivors from a cross-sectional study. Cancer Med. 2024 Jan;13(2):e6975. doi: 10.1002/cam4.6975.

  PMID: 38379321 DERIVED

• Storey S, Draucker C, Haunert L, Von Ah D. The Experience of Peripheral Neuropathy Symptoms in Breast Cancer Survivors With Diabetes. Cancer Nurs. 2024 Jul-Aug 01;47(4):E279-E286. doi: 10.1097/NCC.0000000000001253. Epub 2023 May 26.

  PMID: 37232534 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The NIH NINR lab will run genome-wide sequencing per an approved and standardized protocol. In this study, we will focus on 3 genetic SNP variants of BDNF, APOE, and COMT (described previously). After final batch analyses, only outcome data with the unique identification numbers will be transferred via secure server to be linked back with the other survey and neuropsychological data.

MeSH Terms

Conditions

Cognitive Dysfunction; Pain; Depression; Anxiety Disorders; Fatigue; Parasomnias; Breast Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Diane Von Ah, PhD

  IU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean of Academic Operations

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: November 2, 2020
• Study Start: November 16, 2020
• Primary Completion: May 12, 2021
• Study Completion: July 27, 2021
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

US (1)