ACTIVE_NOT_RECRUITING

Firefighter Collaborative Research Project

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Firefighter Collaborative Research Project

Quick Facts

Study Start:2023-06-22
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05869747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Active firefighter (including emergency medical responder and all firefighter subgroups) with either a volunteer or career status
  2. * Individual plans to remain in active service with their current agency for the next 2 years (not planning to retire or resign)
  3. * 18 years of age and older
  4. * Fluently speak and write in English
  5. * All sexes, races, and ethnicities
  6. * Enrolled in the Fire Fighter Cancer Cohort Study (FFCCS) prior to enrolling in the Firefighter Collaborative Research Project (FCRP)
  7. * Complete a signed and dated informed consent document that indicates the participant has been informed of all aspects of the study prior to enrollment
  8. * Agree to avoid participating in FCRP intervention activities outside of their assigned intervention group for the duration of the study
  9. * Able to comply with scheduled visits, laboratory tests and other study procedures
  10. * BMI of 17.5 kg/m2 or greater and be greater than 115 pounds
  11. * Must also be eligible to donate blood and blood-based products if randomized into the blood or plasmapheresis intervention groups
  12. * Not able to fluently speak or write in English
  13. * Less than 18 years of age
  14. * Currently a tobacco smoker or vaping (e.g. \>2 cigarettes or cigars, or incidents of vaping in the past month)
  15. * Those with planned travel or extended leave (e.g. \>6 weeks) that would prevent their ability to participate in other interventions
  16. * Those who are pregnant, breastfeeding, or have given birth within the past year
  17. * Those with a history or diagnosis of any significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurological, immune, hepatic, renal, urological disorders, severe injury or cancer that, in the opinion of the investigator, would potentially put the candidate at risk.
  18. * Those with any medical contraindication (medical condition or medication) to blood donation
  19. * Those that donated blood or plasma in the past three months
  20. * Those knowing they have a condition indicative of levels of hemoglobin, hematocrit, red blood cells, or iron below the lower limit of normal levels
  21. * Those with a history or diagnosis of diabetes, hypoglycemia thyroid disease, and/or an eating disorder
  22. * Those who recently participated in intermittent fasting or Time Restricted Eating
  23. * Those that recently used antidiabetic medication such as Semaglutide (sold as Ozempic, Wegovy, and Rybelsus) or Tirzepatide (sold as Mounjaro) for the treatment of type 2 diabetes or for weight loss will also be excluded from this group.
  24. * Use of drugs that might affect intermittent fasting or eating behaviors
  25. * Those outside of the state of Arizona
  26. * Currently participating in zone 2 physical activity training
  27. * Currently participating in more than 120 minutes per week of aerobic, cardiovascular training (e.g. jogging, cycling, walking, swimming, HIIT) at \>60% of their max heart rate.
  28. * Those outside of the state of Arizona or in cities in Arizona where access to CPET testing is not possible
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Gilbert Fire & Rescue Department
Gilbert, Arizona, 85295
United States
Green Valley Fire
Green Valley, Arizona, 85622
United States
Tucson Fire Department Headquarters
Tucson, Arizona, 85701
United States
Tucson Fire Department Station 9
Tucson, Arizona, 85711
United States
University of Arizona
Tucson, Arizona, 85719
United States
Northwest Fire District
Tucson, Arizona, 85743
United States
Drexel Heights Fire
Tucson, Arizona, 85746
United States

Collaborators and Investigators

Sponsor: University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-22
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-06-22
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Firefighters

Additional Relevant MeSH Terms

  • Exposure
  • Cardiopulmonary