Early Palliative Care Intervention in Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT03471546|
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Behavioral: Palliative Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients newly diagnosed with World Health Organization (WHO) Grade IV malignant glioma will be referred to a Palliative Care provider in the clinic, in order to assess the impact of early palliative care intervention.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study|
|Actual Study Start Date :||May 16, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: Palliative care
Newly diagnosed patients will be referred to a palliative care provider in the clinic for initial consultation and follow-up during their initial treatment for WHO Grade IV malignant glioma. Patients will be asked to complete a number of questionnaires and assessment forms at different time intervals during the course of their initial treatment. In addition, we will ask patients' neuro-oncology providers for feedback regarding their satisfaction with the Palliative Care services provided to the patient.
Behavioral: Palliative Care
Initial consultation and follow-up with a palliative care provider
- Acceptability: Patient satisfaction [ Time Frame: 8 months ]Mean scores obtained from patient-completed FAMCARE-P16 questionnaires. The FAMCARE-P16 measures patient satisfaction using 16 items on a Likert scale which are summed together to produce an aggregate score of satisfaction. It will be administered at study completion or when a patient is discharged to hospice or withdraws study participation.
- Acceptability: Provider satisfaction [ Time Frame: 8 months ]The percentage of providers who respond "Always" or "Most of the time" to the question "Were you satisfied with your patient's care are the palliative care clinic?" among those providers who complete the Palliative Care Clinic (PCC) Referring Provider Satisfaction Survey upon each patient's study completion.
- Acceptability: Continuation of follow-up with palliative care provider after initial consultation [ Time Frame: 8 months ]The percentage of patients who continue to follow up with their palliative care provider after initial consultation among those who receive initial consultation.
- Acceptability: Continuation of follow-up with palliative care provider beyond study period [ Time Frame: 8 months ]The percentage of patients who respond "Yes" to the question "Do you plan to continue to see a palliative care provider after your participation on the study is complete?" among those who complete the end of study questionnaires. This question will be included in the questionnaires administered at study completion.
- Demand: Time to enroll 50 patients [ Time Frame: 2 years ]The difference in months between the date the first patient is enrolled and the date the 50th patient is enrolled.
- Demand: Enrollment percentage [ Time Frame: 2 years ]The percentage of patients who choose to enroll in the study among those to which the study is offered.
- Implementation: Study completion percentage [ Time Frame: 2 years ]The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.
- Integration: Provider perception of feasibility [ Time Frame: 2 years ]The percentage of providers who respond "Yes" or "Yes with modification" to the question "Do you think that this model of early palliative care referral is feasible to integrate into the existing clinical infrastructure in your outpatient oncology clinic?" among those providers who complete the PCC Referring Provider Satisfaction Survey upon each patient's study completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471546
|Contact: Katherine Peters, MD, PhDfirstname.lastname@example.org|
|United States, North Carolina|
|The Preston Robert Tisch Brain Tumor Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: Katherine Peters, MD, PhD 919-684-5301 email@example.com|
|Principal Investigator: Katherine Peters, MD, PhD|
|Principal Investigator: David Casarett, MD, MA|
|Principal Investigator:||Katherine Peters, MD, PhD||The Preston Robert Tisch Brain Tumor Center|
|Principal Investigator:||David Casarett, MD, MA||Palliative Care|