Exploring the Neuro-Immune Basis of Cancer-Related Fatigue Using Behavioral Measures

NCT02255773 | Completed

• 2 other identifiers: 2014-0511NCI-2015-00012
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research study is to learn more about fatigue and how it affects your behavior as well as your willingness to learn new behaviors.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; HNC; Moderate to severe fatigue; Computerized tasks; Questionnaires; Surveys; Disease-free adult males; Cancer survivors

Outcome Measures

Primary Outcomes (1)

• Fatigue Comparison in Male Head and Neck Cancer Survivors

  Endpoint for Effort Expenditure for Rewards Task (EEfRT) is ratio of hard task choices (number of hard task choices/total choices) across levels of probability. Endpoints for associative learning task are number of trials until reaching the a priori defined learning criterion (three consecutive correct responses for each association), indicating goal-directed learning, and number of trials between reaching this criterion and reaching asymptote in the reaction times, indicating establishment of habitual behavior. Set-switching task primary endpoints is difference in reaction times and number of errors between "no-switch" and "switch" trials.

  1 day

Secondary Outcomes (1)

• Markers of Inflammation and Fatigue

  1 day

Study Arms (2)

High-Fatigue Head and Neck (HNC) Cancer Survivors

OTHER

Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.

Behavioral: Computerized Tasks; Behavioral: Questionnaires

Low-Fatigue Head and Neck (HNC) Cancer Survivors

OTHER

Participants undergo assessment with three validated computerized tasks designed to measure the neurobehavioral domains of interest: the Effort Expenditure for Rewards Task (EEfRT), an associative learning task, and a set-switch task. Participants complete questionnaires assessing mood, somatic symptoms, and sleep quality, including the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), the Checklist Individual Strength (CIS), and others. A 10-mL blood sample drawn for assessment of inflammatory markers and COMT and DAT1 genotype.

Behavioral: Computerized Tasks; Behavioral: Questionnaires

Interventions

Computerized Tasks BEHAVIORAL

3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks.

High-Fatigue Head and Neck (HNC) Cancer Survivors; Low-Fatigue Head and Neck (HNC) Cancer Survivors

Questionnaires BEHAVIORAL

Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.

Also known as: Surveys

High-Fatigue Head and Neck (HNC) Cancer Survivors; Low-Fatigue Head and Neck (HNC) Cancer Survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patients at least 18 years old.
• Patients who completed either definitive or postoperative radiation or chemoradiation therapy for head and neck cancer within the past 6 weeks to 120 months.
• Patients who speak English.
• Patients who are willing and able to review, understand, and provide written consent.
• Patients who agree to comply with all study procedures.

You may not qualify if:

• Patients with clinical evidence of active persistent cancer or progressive disease after completing planned cancer therapy, or with active recurrent cancer.
• Patients with potential medical or other underlying causes of fatigue, as determined by the treating physician or Principal Investigator.
• Patients with underlying cardiac or pulmonary disease resulting in dyspnea, hypoxia, or hypercapnia.
• Patients with major depressive disorder or severe depression (a score of 22 or greater on the Center for Epidemiologic Studies Depression (CES-D)); for scores of 16 or higher, we will notify the patient's treating physician within 1 working day of the screening to allow for appropriate management or referral.
• Patients currently taking, or having taken within the previous 1 month, armodafinil, modafinil, amphetamine, or methylphenidate.
• Patients who are enrolled and receiving active treatment in a symptom intervention trial or who are in the treatment phase of a clinical trial.
• Patients experiencing moderate to severe pain (4 or higher on a 0 to 10 scale) at the time of screening.
• Patients who cannot distinguish between the red and blue stimuli of the set-switch task.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Robert Dantzer, DMV,PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 3, 2014
• Study Start: November 4, 2014
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

US (1)