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Behavioral Measures for Cancer-Related Fatigue
N/A
Waitlist Available
Led By Robert Dantzer, DMV,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day
Awards & highlights
Study Summary
This trial is testing if a new way to measure and track fatigue could help people with MS manage their symptoms.
Who is the study for?
This trial is for English-speaking male adults who have completed treatment for head and neck cancer within the last 10 years. They must be able to consent, follow study procedures, and not suffer from severe pain, depression, or diseases causing breathing issues. Those on certain stimulants or in other symptom intervention trials are excluded.Check my eligibility
What is being tested?
The study aims to understand cancer-related fatigue by having participants engage in computerized tasks and fill out questionnaires. It explores how fatigue influences behavior and learning new behaviors after cancer treatment.See study design
What are the potential side effects?
Since this trial involves behavioral measures like computer tasks and questionnaires rather than medication or invasive procedures, significant side effects are not expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fatigue Comparison in Male Head and Neck Cancer Survivors
Secondary outcome measures
Markers of Inflammation and Fatigue
Trial Design
2Treatment groups
Experimental Treatment
Group I: Low-Fatigue Head and Neck (HNC) Cancer SurvivorsExperimental Treatment2 Interventions
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.
Group II: High-Fatigue Head and Neck (HNC) Cancer SurvivorsExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computerized Tasks
2014
N/A
~20
Questionnaires
2013
Completed Phase 2
~3330
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,790 Total Patients Enrolled
Robert Dantzer, DMV,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have moderate to severe pain (rated 4 or higher on a scale of 0 to 10) during the screening process.You have a heart or lung condition that causes difficulty breathing, low oxygen levels, or high carbon dioxide levels.You have an underlying medical condition that could cause fatigue, as determined by your doctor or the study leader.
Research Study Groups:
This trial has the following groups:- Group 1: High-Fatigue Head and Neck (HNC) Cancer Survivors
- Group 2: Low-Fatigue Head and Neck (HNC) Cancer Survivors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions in the trial for new participants?
"This clinical trial, which was first advertised in November 2014 and modified most recently on August 18th 2022, is not actively recruiting patients. Consequentially, interested participants must look to other medical trials for opportunities; 692 such studies are open for enrollment currently."
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