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Completed

NCT Number: NCT03471546

Early Palliative Care Intervention in Malignant Glioma

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.

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Preston Robert Tisch Brain Tumor Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palliative Care

Behavioral

Initial consultation and follow-up with a palliative care provider

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Implementation: Study completion percentage

    Time frame: 2 years

    The percentage of patients who complete all study-related questionnaires and procedures among those enrolled.

  8. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Cancer Institute

Registry information

Official study title

Model of Early Palliative Care Intervention in Patients With Newly Diagnosed WHO Grade IV Malignant Glioma, a Single Arm Feasibility Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2018
Registry last updated
Nov 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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