Early Palliative Care Intervention in Malignant Glioma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 16, 2018 |
| End Date: | May 2020 |
| Contact: | Katherine Peters, MD, PhD |
| Email: | dukebrain1@dm.duke.edu |
| Phone: | 9196845301 |
Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study
The purpose of this research study is to determine the feasibility and acceptability of
incorporating palliative care into the clinical care plans of patients newly diagnosed with
malignant brain tumors. Palliative Care is a field of medicine that focuses on providing
relief from symptoms and stress related to serious illnesses. This study will assess the
feasibility of conducting a future study, and will gather data upon which to appropriately
tailor the intervention and the future study design. The statistical analysis of this study
will describe 8 components that encompass each of the 4 areas of focus or "domains":
acceptability, demand, implementation, and integration.
incorporating palliative care into the clinical care plans of patients newly diagnosed with
malignant brain tumors. Palliative Care is a field of medicine that focuses on providing
relief from symptoms and stress related to serious illnesses. This study will assess the
feasibility of conducting a future study, and will gather data upon which to appropriately
tailor the intervention and the future study design. The statistical analysis of this study
will describe 8 components that encompass each of the 4 areas of focus or "domains":
acceptability, demand, implementation, and integration.
Patients who agree to participate at their initial consultation in our clinic will receive a
referral to a Palliative Care (PC) provider who is also located in our clinic and an initial
appointment will be scheduled with the PC provider. The frequency of follow-up visits with
the PC provider will be at the discretion of the PC provider and the patient. Visits with the
PC and neuro-oncology providers will be scheduled on the same day whenever possible. As part
of the study, participants will be asked to complete a number of questionnaires and
assessment forms at different time intervals. These questionnaires and assessments are
intended to track symptoms experienced during the course of treatment. Total study duration
is about nine months.
referral to a Palliative Care (PC) provider who is also located in our clinic and an initial
appointment will be scheduled with the PC provider. The frequency of follow-up visits with
the PC provider will be at the discretion of the PC provider and the patient. Visits with the
PC and neuro-oncology providers will be scheduled on the same day whenever possible. As part
of the study, participants will be asked to complete a number of questionnaires and
assessment forms at different time intervals. These questionnaires and assessments are
intended to track symptoms experienced during the course of treatment. Total study duration
is about nine months.
Inclusion Criteria:
- ≥ 18 years of age
- Patient must have histologically confirmed, newly diagnosed WHO grade IV malignant
glioma (confirmation from biopsy, sub-total, or gross-total resection)
- Tumor must be de novo grade IV malignant glioma (i.e. NOT transformed from a lower
grade)
- Patient should be planning to receive standard chemoradiation (3 or 6 week protocols
are acceptable)
- Treating neuro-oncologist agrees to the patient's participation in this clinical trial
- Patient should be able to read and write English
Exclusion Criteria:
- Patient who currently has a PC provider and/or is receiving hospice care or plans on
initiating hospice at the time of enrollment
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Katherine Peters, MD, PhD
Phone: 919-684-5301
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