Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer, Cardiology, Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/26/2018 |
Start Date: | June 2009 |
End Date: | June 2020 |
A Prospective Study of Cancer Patients Diagnosed With Unsuspected Venous Thromboembolism (VTE) on Routine Computed Tomography (CT) Scans
This is a prospective study with the following objectives:
Primary Objective:
1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT
scans of the thorax, abdomen and pelvis.
Secondary Objectives:
2. To identify symptoms commonly associated with VTE that are present in cancer patients
undergoing routine staging CT scans with findings of unsuspected VTE.
3. To identify the risk factors and demographic characteristics in outpatient cancer
patients associated with the development of unsuspected VTE.
4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at
3 and 6 months of follow-up.
Primary Objective:
1. To estimate the prevalence of unsuspected VTE in oncology patients on routine staging CT
scans of the thorax, abdomen and pelvis.
Secondary Objectives:
2. To identify symptoms commonly associated with VTE that are present in cancer patients
undergoing routine staging CT scans with findings of unsuspected VTE.
3. To identify the risk factors and demographic characteristics in outpatient cancer
patients associated with the development of unsuspected VTE.
4. To determine the incidence of recurrence of new VTE in patients with unsuspected VTE at
3 and 6 months of follow-up.
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.
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.
Inclusion Criteria:
1. Patients with a diagnosis of cancer.
2. Subjects must be 18 years or more.
3. Male and female patients are eligible for enrollment.
4. Patients who are scheduled for routine outpatient cancer staging using CT scans.
5. Patients must be able to complete the required survey tools independently.
6. Patients must be able to speak, read and write English.
Exclusion Criteria:
1. Patients who have a clinically suspected VTE and/or scheduled for CT scans for
suspected VTE.
2. Patients not willing to complete survey tools.
3. Prior history of PE or DVT.
4. Eastern Cooperative Oncology Group (ECOG)/Zubrod Performance Status score of 4.
5. Patients currently on anticoagulation therapy (low molecular weight heparin,
fondaparinux, dalteparin, warfarin or unfractionated heparin). Patients on heparin
flushes for indwelling catheters will not be excluded.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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