Palliative Care Clinical Trial
— EPIICCOfficial title:
Early Palliative Care Integration in Interventional Cancer Care
Verified date | April 2018 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team. Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Caregiver Well-being Scale | The caregiver well-being Scale will measure the Caregiver Well-Being. | 1, 2 and 3 months | |
Other | Caregiver Quality of Life-Cancer Scale | The caregiver Quality of Life-Cancer Scale will measure the quality of life of subjects with cancer. | 1, 2 and 3 months | |
Other | Measure the decrease in the score of the Center for Epidemiologic Studies Depression Scale (CES-D). | It is anticipated that the CES-D score will be decreased from baseline as a result of the proposed intervention. | 1, 2 and 3 months | |
Other | Health services utilization | Subsequent to the integration of palliative care resulting in improved patient outcomes, the frequency of ED visits, ICU visits, and hospital stays will decrease. | 1, 2 and 3 months | |
Other | Health services costs | Subsequent to the integration of palliative care resulting in improved patient outcomes, the frequency of ED visits, ICU visits, and hospital stays will decrease and therefore reduce costs. | 1, 2 and 3 months | |
Primary | Changes in Edmonton Symptom Assessment Score (ESAS-R) | Measure the impact of an early palliative care intervention on patient physical and psychosocial outcomes. The early integration of palliative care at diagnosis or immediately post- procedure, will improve patients' physical and psychosocial symptoms. The score of such assessment should decrease from baseline as the result of the intervention. | 1, 2 and 3 months | |
Secondary | Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status | Measure the decrease of the ECOG status as a result of the proposed intervention. | 1, 2 and 3 months |
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