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This is a research study to evaluate change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30), from baseline to 1 month post treatment in two patient cohorts receiving Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Radiology Liver Directed Therapies (ILDT) | Active Comparator | ILDT includes ablations such as microwave ablation and percutaneous local ablation and embolotherapies including bland embolization, chemoembolization and radioembolization. |
|
| Hypofractionated Image-Guided Radiation Therapy (HIGRT) | Active Comparator | HIGRT is a non-invasive, outpatient procedure typically delivered in 3-10 fractions of radiation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quality of life questionnaires | Other | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) |
| Measure | Description | Time Frame |
|---|---|---|
| change in quality of life in patient cohorts receiving either Interventional Radiology Liver Directed Therapies or Hypofractionated Image-Guided Radiation Therapy | as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC C-30) measured from not at all (better) to very much (worse) | baseline, 1 month, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in quality of life in patients receiving Interventional Radiology Liver Directed Therapies or HIGRT | as measured by the FACT-Hep survey questionnaire from not at all (better) to very much (worse) | baseline, 1 month, 3 months, 6 months |
| number of patients with grade ≥2 acute toxicity that received Interventional Liver Directed Therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather Franklin | Contact | (919) 668-3726 | heather.mccullough@duke.edu | |
| Linda Kaltenbach, PhD | Contact | Linda.Kaltenbach@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Manisha Palta, MD | Duke Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Durham Veterans Administration Health Care System (DVAHCS) | Recruiting | Durham | North Carolina | 27705 | United States |
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| 90 days |
| number of patients with grade ≥2 acute toxicity that received Hypofractionated Image Guided Radiation Therapy | 90 days |
| total healthcare system cost associated with Interventional Radiology Liver Directed Therapies | 90 days |
| total healthcare system cost associated with Hypofractionated Liver Directed Therapy | 90 days |
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
|
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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