Burn Pit Exposure in Veterans: A Cancer Screening Pilot Study at the Inova Saville Cancer Screening & Prevention Center
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rebecca Kaltman, MD · PRINCIPAL_INVESTIGATOR · Inova Health Care Services
- Stephanie VanBebber · STUDY_DIRECTOR · Inova Health Care Services
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- STAI Questionnaire3.5 years
Participant Satisfaction and psychosocial impact of cancer screening will be measured by the Anxiety and Satisfaction Survey. The STAI is a validated anxiety tool that has been used in a variety of research and clinical settings, including studies of cancer screening. The survey will be administered at the following timepoints: After enrollment, before each of the up to 8 screening procedures, after each screening procedure, and after the 1 year screening period. The state component of the questionnaire will be administered at the following timepoints: 12-month study visit, 24-month study visit, before each of the up to 8 screening procedures, after post results review from the previous screening assessment, and follow up (1 year + 2 months following the last screening assessment). STAI scores are computed on a scale from 20-80, with higher scores representing a higher degree of anxiety.
- Burn Pit Exposure Questionnaire1 day
This questionnaire will determine the demographic, clinical, lifestyle, and burn pit exposure characteristics of participants in the intensive cancer screening regimen. This questionnaire administered during baseline will assess the position, branch, and dates of military service for each participant and whether they were stationed, worked, and/or lived near a burn pit during those dates of service. The questionnaire will also include an assessment of the specific types of duties that the participant performed if working near the burn pit and how many hours they were exposed to smoke or fumes from the burn pit on a typical day. Participants' demographic, lifestyle and clinical, and burn pit exposure characteristics will be summarized using descriptive statistics
- Cancer Outcomes Follow up Questionnaire1 day
This questionnaire will describe the number, proportion, and stage of confirmed pre-malignant and malignant findings in veterans exposed to burn pits during each annual screening period and during follow-up for the intensive cancer screening protocol. This questionnaire is completed at 12 (+ 2) months following the 24-month screening assessment by phone or electronically. This questionnaire will assess information on any new diagnoses of cancer since the last screening visit. This information can also be collected from medical records without direct participant contact instead of questionnaire if available within the timeframe. The number, proportion, and type and stage of confirmed cancers, and participant demographic, lifestyle, and clinical characteristics will be summarized using descriptive statistics.
- Intensive Cancer Screening Feasibility2 years
Feasibility will be defined as 75% of enrolled participants completing at least 80% of the cancer screening assessments for which they are eligible during each screening period. Any adverse events resulting from the study procedures will be monitored by the research and clinical team during the study visits and will also be assessed during follow-up with participants when the results of screening examinations are provided. The assessments include: * Laboratory assessments (CBC, CMP, TSH, LDH, PSA, urinalysis) * ENT, skin (with Vectra), breast, and neurological exams * Pulmonary function test (PFT) * Flexible Laryngoscopy * Stool-based colon cancer screening (age 35-44 years) * Mammogram (women age 35-39) * Low-dose CT scan of the chest * Brain MRI with contrast (only for those with abnormal neuro exam) * Testicular ultrasound