Trial Information

A Prospective Study of Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans

Patients diagnosed with cancer are routinely scheduled for staging CT scans. The CT scans
are obtained to stage a new cancer diagnosis, to restage a cancer after treatment initiation
or to evaluate abnormal masses, disease progression or metastasis. The study population will
include outpatients scheduled for routine CT scan of the chest, abdomen and/or pelvis.

While patients are waiting in the Diagnostic Imaging waiting area, they will be invited to
participate in the study. Study eligibility will be determined by administering a screening
questionnaire. Cancer patients who meet the eligibility criteria will be asked to
participate in the study. It is imperative that the patient completes the surveys and not
the caregiver. A caregiver may lend assistance in transcribing the information but may not
complete the instruments independent of the patient.

Many of these tools are brief and the estimated completion time should be approximately 15
to 30 minutes. Additionally completing the instruments will not extend beyond the time the
patient is in the CT scan waiting area prior to the scheduled study.

On the day of study enrollment, patients will be asked to complete Brief Fatigue Inventory
(BFI), MD Anderson Symptom Inventory (MDASI), Dyspnea Numerical Scale (DNS), Cancer Dyspnea
Scale (CDS), ECOG/Zubrod Performance scale, Depression Anxiety Stress Scale (DASS 21), VTE
Symptom Enrollment Questionnaire and Functional Assessment of Cancer Therapy-General
(FACT-G). The patients will also complete a questionnaire on symptoms of VTE such as chest
pain, pain or swelling of the extremities and other common symptoms reported in VTE
patients.

VTE Symptom Follow-up Questionnaire:This instrument was designed for this study. Patients
will be asked at 3 and 6 months the treatments received, recurrence of VTE, incidence of
bleeding episodes and other health related conditions.