Treatment Trials

50 Clinical Trials for Various Conditions

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ENROLLING_BY_INVITATION
Glucose Levels as a Biomarker for Stress in Firefighters
Description

Stress is known to cause physical structures in the brain to dysregulate, resulting in health problems like cancer, cardiac disease, metabolic disorders (obesity), and depression. Firefighters experience many of these diseases at higher rates than other occupations while also experiencing highly unique stress loads. When the body's nervous system responds to stress, blood glucose levels increase. This study will equip firefighters with continuous glucometers to observe glucose levels during emergency response and other stressful events. The immediate goal of this study is to determine whether the physiological stress response of on-shift firefighters can be quantified with glucose monitoring. The long-term goal is to identify occupational firefighter stress as a health risk exposure.

RECRUITING
"F!reF!ghterF!t": a Randomized Controlled Trial of Lifestyle Coaching Interventions for Obese Firefighters
Description

Our goal is to explore the effectiveness of 9- month lifestyle medicine based coaching intervention (individual and group coaching) versus control (usual care/ written health instructions). The primary study outcomes will be mean changes in body composition metrics . Secondary outcomes will be the prevalence of metabolic abnormities, progression/regression of Metabolic Syndrome, push-up \& sit/stand capacity, self-reported physical activity, and quality of life/diet/sleep measures.

RECRUITING
Pre-malignant States to Hematologic Malignancies in Firefighters
Description

The purpose of the study is to evaluate if firefighter exposure to hazardous compounds will increase the incidence of premalignant hematological states which subsequently increases the risk of the development of hematologic malignancies, and potentially other pathophysiological consequences.

ENROLLING_BY_INVITATION
Evaluating Worksite Sleep Health Coaching in Firefighters: The Sleep Assistance for Firefighters Study
Description

Insufficient sleep is a significant public health issue, particularly affecting shift workers like firefighters, nearly half of whom report short or poor-quality sleep, with 35-40% screening positive for sleep disorders. Cognitive Behavioral Therapy for Insomnia (CBTi) is a recommended and effective treatment, but access to such interventions remains low. This study will recruit 20 fire agencies in Arizona (400 firefighters) to test if a CBTi-informed intervention, including sleep health coaching and agency-wide promotion, improves sleep more effectively than usual care. The trial will also explore factors that influence successful implementation across agencies.

RECRUITING
Effect of Rapid Heat Stress on Firefighters Musculoskeletal Injury Risk
Description

This study will examine the effect of heat stress on factors that influence musculoskeletal injury risk in firefighters. Participants will attend 4 data collection sessions. 1: informed consent, screening, and familiarization. 2: pre-tests (strength, balance, and movement quality). 3: heat stress (rapid or gradual) followed by post-tests (strength, balance, and movement quality). 4: heat stress (rapid or gradual) followed by post-tests.

ACTIVE_NOT_RECRUITING
Firefighter Collaborative Research Project
Description

The goal of this research is to test interventions to reduce firefighter cardiovascular, cognitive, and overall disease risks, including but not limited to risks associated with Per- and Polyfluorinated Substances (PFAS) exposure. Approximately 1,500 - 2,000 firefighters will be enrolled in the Fire Fighter Cancer Cohort Study (FFCCS). Among these individuals, those that express interest will then be screened for eligibility for the Firefighter Collaborative Research Project (FCRP) using information they provided for the Fire Fighter Cancer Cohort Study. Firefighters enrolled in the study will provide an initial blood sample and urine sample. The blood sample will be analyzed to determine the participant's PFAS levels. Based upon serum PFAS levels and responses from the screening survey, eligible participants will be randomly assigned into one of the following interventions: 1. Blood Donation, or Plasma Donation or Blood/Plasma Control Group; 2. Zone 2 Training or Zone 2 Control; 3. Intermittent Fasting or Intermittent Fasting Control. Individuals participating in the blood donation, plasma donation or blood/plasma control group would donate blood every 12 weeks, plasma every 6 weeks, or not donate blood or plasma. Participants in this intervention arm would continue this for a 12-month period. Individuals in the zone 2 training, zone 2 training control, intermittent fasting or intermittent fasting control group would participate in their intervention or control for a 4-month period. After 4 to 12 months participating in an intervention or control group, participants will be asked to provide a final urine sample and blood draw to determine if and to what degree their PFAS levels or other cardiovascular disease and other health risks have changed.

COMPLETED
Total Worker Health for Wildland Firefighters
Description

The overarching goal is to develop, refine and disseminate a comprehensive, easily accessible and effective Total Worker Health (TWH) program for wildland firefighters (WFF). The term Total Worker Health® (TWH) (NIOSH) refers to the synergistic combination of 1) health promotion (e.g., healthy nutrition, exercise, restorative sleep), 2) worker safety issues, such as protective equipment and hazard control, merged with 3) work organization change to support and promote TWH.

ENROLLING_BY_INVITATION
Feasibility of a Train-the-Trainer Delivered Exercise Intervention in Firefighters
Description

Purpose: To collect and report feasibility data for conducting a future cluster randomized trial to evaluate the efficacy of a TRAINER delivered integrated exercise program in career firefighters, and to determine intervention fidelity and preliminary effects of a TRAINER delivered integrated exercise program in career firefighters. Participants: 52 career firefighters 18 - 60 years old (40 trainees, 6 trainers, 6 administrators). Procedures (methods): Enrolled fire stations will be randomly assigned (3:2 allocation ratio) to a TRAINER or wait-list control (CON) group, stratified by city, using computer-generated random numbers. All enrolled firefighters will undergo a series of assessments at baseline (week 0) and post-testing (week 7) following the TRAINER delivered 6-week intervention.

COMPLETED
Smokeless Tobacco Cessation Intervention for Firefighters
Description

The investigators are asking professional firefighters across North Carolina to take part in focus groups to discuss the specific needs of firefighters in smokeless tobacco cessation. About 40 firefighters will take part in the focus groups. The purpose of the focus groups is to learn how firefighting and shift work impact smokeless tobacco use and risk perceptions related to chew or dip. Using their feedback, the study team will then develop a cessation program specifically geared towards firefighters and first responders. The cessation program will be a mobile text / chat intervention specifically tailored to needs of firefighters and first responders who wish to stop using smokeless tobacco. About 50 firefighters and first responders will take part in this program, while being randomized into either the intervention group or the control group.

COMPLETED
A Pilot Study of Cognitive Behavioral Therapy - Insomnia (CBT-I) Among Professional Firefighters
Description

The primary aim of this study is to investigate the feasibility, acceptability, and preliminary efficacy of an adapted Cognitive Behavioral Therapy - Insomnia (CBT-I) intervention in improving sleep in a firefighter population.

COMPLETED
Mindful Attention Training Workshop for Firefighters
Description

The overarching goal of this study is to demonstrate the efficacy, feasibility, and acceptability of Mindful Attention Training (MAT), a novel mindfulness-based intervention that is specifically developed for firefighters. This project is designed to improve the health of firefighters, an integral, essential component of our national and international communities. Moreover, the study aims to promote health service psychologists by enhancing our contributions to the mental healthcare of firefighters, an understudied and underserved segment of the population by virtue of their service to our communities. This study therefore has significant potential to identify, develop, and promote an effective model of quality, evidence-based mental health promotion and illness prevention by integrating health service psychology into the fire service.

COMPLETED
The Influence of Cardiorespiratory Fitness on Firefighter Cardiovascular Health Under Exercise Conditions
Description

Sudden cardiac death (SCD) is the number one cause of on-duty firefighter death. It is most likely to occur in adults who are not physically fit that engage in sudden vigorous exercise. Cardiorespiratory physical fitness (also known as aerobic fitness) is a major heart disease risk factor. In FIT and FIRED UP, the study investigators looked at the influence of cardiorespiratory fitness on blood pressure, heart rate, and other heart markers taken from the blood before and after a vigorous exercise test to maximal effort among firefighters from a local fire department in Connecticut. In addition, the investigators also looked at how lifestyle habits including physical activity, nutrition, stress, and sleep may influence our findings. It was hypothesized that aerobically fit firefighters would show less stress on their heart than unfit firefighters.

COMPLETED
Evaluation of Post-Exposure Sauna Treatment of Firefighters - A Pilot Study
Description

Firefighters are at increased risk of cancer, and both inhalation and dermal routes contribute to overall exposure to carcinogens, including polycyclic aromatic hydrocarbons (PAHs). The purpose of the current study is to determine if post-fire firefighter rehabilitation in an infrared sauna: a) affects absorption of PAHs as measured by urinary metabolites; and b) changes core body temperature and heart rate.

COMPLETED
The First Twenty for Volunteer Firefighters
Description

The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.

COMPLETED
Feeding America's Bravest: Mediterranean Diet-Based Interventions to Change Firefighters' Eating Habits
Description

The purpose of this study is to modify the food culture of the fire service by motivating firefighters and their families to incorporate Mediterranean diet principles at work and home through behavior change strategies that involve education, participation and incentives. The ultimate purpose is to lower firefighters' risks for CVD and cancer by successfully getting more firefighters and their families to adopt and incorporate the healthy eating principles behind the Mediterranean diet.

COMPLETED
Worksite Exercise Interventions for Low Back Injury Prevention in Firefighters
Description

Purpose and Aims: The purpose of this study is to assess the clinical effectiveness of back and core exercise interventions for low back injury prevention in firefighters. Aim 1. Compare the effectiveness of 2 worksite exercise interventions (supervised, web-based) relative to control to reduce lost work days related to low back injury and illness in firefighters. Relevance: Low back injury is one of the most common and disabling disorders in firefighters. Thus, novel interventions are needed to counteract the adverse consequences of this disorder and its impact on firefighter safety. Methods: A cluster randomized controlled trial will be conducted in career, full active duty firefighters (n = 345) who will be randomly assigned (by fire station) to 1 of 3 intervention groups - 1) supervised exercise (n = 115), 2) web-based exercise (n = 115), or 3) control (n = 115). Participants in the supervised and web-based exercise groups will perform back and core exercises previously tested in our recent FEMA-funded grant (EMW-2009-FP-00418), twice per week for 12 months while on duty, in addition to their usual physical fitness routine - The supervised group will perform exercise under direct supervision of certified exercise specialists, and the web-based group will utilize a web-based exercise system. The control group will not perform back and core exercises, but will continue their usual physical fitness routine and receive brief education on general exercise and physical activity principles. Outcome measures include low back injury and illness data obtained and cross-checked from various sources, other standard clinical outcome measures for low back pain and disability, and validated physical fitness tests. Anticipated Outcomes: We hypothesize that the supervised and web-based interventions will reduce lost work days related to low back injury and illness by 40% compared with control. Assuming positive results, this study will deliver an evidence-based exercise intervention for low back injury prevention specifically designed for firefighters and assessed in a full-scale randomized controlled trial.

Conditions
COMPLETED
Enhanced Firefighter Rehab Trial: The Role of Aspirin in Preventing Heat Stress Induced Platelet Activation
Description

The purpose of this study is to determine if aspirin taken by firefighters prevents platelets from becoming sticky when body temperature rises during work in protective clothing.

RECRUITING
Occupational Cancer Screening in Firefighters: A Pilot Study Within the Inova Health System
Description

The purpose of this study is to further understand the clinical impact and follow-up steps that may be required based on using whole-body Magnetic Resonance Imaging (MRI) or whole-body ultrasound and blood tests to detect multiple cancers in firefighters. This study involves an investigational test (cancer blood test) that has not been approved by the U.S. Food and Drug Administration (FDA). Whole-body MRI and whole-body ultrasound are approved by the U.S. Food and Drug Administration (FDA) to be used in the diagnosis of some cancers and is approved for adults and children who present other signs of potential disease. In this study, however, the whole-body MRI and the whole-body ultrasound are considered investigational devices because they are not yet approved for use in healthy adults with no other cancer indications.

Conditions
NOT_YET_RECRUITING
Lung Cancer Screening CT for Firefighters
Description

Firefighters are at increased risk for cancer due to exposure to carcinogenic substances. Current lung cancer screening guidelines are predominantly based on smoking history and do not take into account high risk occupational exposures such as firefighting. This study aims to provide chest computed tomography (CT) scans to firefighters to determine the prevalence of lung cancer, other cancers detectable on CT chest, and lung diseases associated with increased cancer risk.

RECRUITING
IGNITE Firefighters' Health
Description

Investigators hope to learn about potential dietary intervention strategies (specifically a whole-food, plant-based diet) that may help lower cancer markers in firefighters.

RECRUITING
Meditation to Reduce Firefighter Distress
Description

The more than one million firefighters in the United States provide critical emergency medical services in communities they serve and are on the front lines of healthcare delivery, including in the post-pandemic world. As a result of exposure to occupational stressors, a high proportion of firefighters experience considerable stress-related burden including psychological distress (i.e., increased features of anxiety and depression). To address this need, this project will test the efficacy of a 10-day meditation intervention (i.e., 10 individual prerecorded audio units delivered by smartphone app) among career firefighters to decrease psychological distress (i.e., anxiety and depression).

RECRUITING
Occupational Exposures Among Firefighters
Description

This study aims to understand the effect of occupational exposures, including PFAS exposures, among firefighters.

Conditions
COMPLETED
The Effects of Nutritional Supplementation on Occupational Performance in Firefighters
Description

The purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding. Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. Therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.

Conditions
COMPLETED
Firefighter Thermoregulatory Responses in Active Fire with Betaine Supplementation
Description

The goal of this clinical trial is to compare betaine supplementation to placebo in firefighters undergoing live burn training regarding thermoregulation and inflammation. The main questions it aims to answer are: * Does betaine supplementation mitigate rises in core temperature during firefighter live burn training? * Does betaine supplementation decrease inflammation from firefighter training? * Does betaine supplementation increase total body water stores? Participants will supplement with betaine for 1 month and complete: * Total Body Water measures * Body Composition measures * Live Burn training with Core Temperature Measurements * Provide Salivary samples

SUSPENDED
Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters
Description

This phase II trial tests how well broccoli seed and sprout extract (BSSE) also called Avmacol extra strength (ES) works to help break down (detoxification) some of the cancer-causing chemicals (carcinogens) that firefighters are exposed to in order to help protect cells from damage. Firefighters are routinely exposed to carcinogens during the course of their daily duties particularly from fuel leaks and smoke exposure arising from active fire rescue, structural or incidental firefighting, or burning, as well as flashover training. Fuel leaks and fires release toxic and carcinogenic substances. These substances, many of which are known carcinogens, increase the risk of cancer in firefighters. Several studies to date have demonstrated that firefighters are at an increased risk of developing various malignancies including melanoma, multiple myeloma, acute myeloid leukemia, prostate, kidney, brain, and respiratory tract cancers, among others. Broccoli extract has the potential to effectively enhance detoxification. Since acetaminophen (Tylenol or generic Tylenol) and some cancer-causing chemicals are broken down (metabolized) by the body in similar ways, this trial may help researchers learn if BSSE can help metabolize acetaminophen to understand how the body might break down these cancer-causing chemicals.

COMPLETED
Addressing Colorectal Cancer in South Florida Firefighters
Description

The standard way of screening for colorectal cancer is to have a series of fecal blood tests, where a sample is taken from a participant's stool, or an endoscopic procedure performed by a doctor, where a camera is used to look inside the bowel. This research study will use a test performed by the participant. This test will look for changes in the stool that can identify if participants are at higher risk for cancer. Another aim of this study is to better understand what firefighters and retired firefighters think about colorectal cancer and other health issues. This information will help us develop programs that may improve colorectal cancer outcomes in the firefighter community.

COMPLETED
An Efficient Treatment for Posttraumatic Injury for Firefighters
Description

The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are: * Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares? * What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares? We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will: * Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares * Attend an individual treatment orientation session * Attend a 4-day (\~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N * Attend an individual booster session held approximately one week later * Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.

RECRUITING
Multi-Cancer Early Detection (MCED) of Firefighters
Description

This study is an an observational prospective cohort research study to explore the performance of new blood and urine tests for the early detection of cancer among firefighters.

Conditions
RECRUITING
Observational Study of Exposure to Environmental Toxicants Among Firefighters
Description

Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.

Conditions
COMPLETED
EaseAlert: Tactile Firefighter Alerting System
Description

The purpose of this research is to test a commercially viable Fire Fighter Altering System (FFAS) comprised of proprietary wearables and optional bed shakers called BunkAlerts; collectively "personal alerting devices" as an alternative approach to the traditional fire alarm system used in fire stations. Participants (fire fighters) will be asked to take part in the study to investigate the impact of the new FFAS on cardiovascular response and sleep. This study includes three phases: 1) baseline, 2) implementation of EaseAlert FFAS with traditional alarm, and 3) implementation of EaseAlert FFAS without traditional alarm. Participants will be asked to wear an Actigraph wGT3x-BT and Polar H10 device to record sleep and heart rate data for 12 days at work in addition to EaseAlert FFAS device for 8 out of the 12 days at work. They will also be asked to complete a questionnaire and complete daily journal entries.