Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers
Pilot Study of Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers
2 other identifiers
interventional
16
1 country
1
Brief Summary
This trial assesses the quality of life in patients with high grade glioma and their caregivers using a questionnaire called the Beacon Patient Related Outcomes Quality of Life (PROQOL). Knowledge gained from this trial may help researchers find out if early integration of palliative care will lead to improvement in quality of life for both patients and caregivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedFirst Submitted
Initial submission to the registry
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 16, 2020
CompletedMarch 20, 2023
March 1, 2023
1 year
November 10, 2020
March 16, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change in feasibility of using the Beacon Patient Reported Outcomes Quality of Life Scale (PROQOL)
Patients will be randomized to 3 groups - Control (standard of care); Arm A (PROQOL + standard of care); Arm B (early palliative care + Arm A). Feasibility of conducting the assessment at monthly visits for each patient/caregiver cluster, along with early involvement of palliative care, will be assessed.
monthly for six months
Change in feasibility of using a single question to assess prognostic understanding in patients, caregivers, and clinicians
At each visit, patients, their caregivers, and the clinicians will be asked to estimate survival time left with options being weeks, weeks to months, several months to years, indefinite number of years, or they may choose not to answer.
monthly for 6 months
Secondary Outcomes (2)
Quality of life of patients and caregivers
Up to 6 months
Discordance in prognostic understanding over time
Up to 6 months.
Study Arms (3)
Group A (visit with neuro-oncologist)
EXPERIMENTALPatients and primary caregiver complete the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months to address concerns that are identified via the survey and the domain of concern identified by patient and caregiver.
Group B (visit with neuro-oncologist and palliative care team)
EXPERIMENTALPatients and primary caregiver complete the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist and palliative care team monthly for 6 months to address concerns that are identified by the survey and domains of concerns. Caregivers also attend support sessions led by a social worker monthly for 6 months.
Group C (visit with neuro-oncologist, palliative care team)
ACTIVE COMPARATORPatients and primary caregiver complete quality of life portion of the BEACON PROQOL survey before each visit. Patients then receive standard of care for high grade glioma consisting of visits with neuro-oncologist monthly for 6 months and address important concerns that come up on the survey. Patients may also receive palliative care consultation as deemed appropriate by the neuro-oncologist.
Interventions
Visit with palliative care team
Ancillary studies
Visit with neuro-oncologist
Complete survey
Eligibility Criteria
You may qualify if:
- Adults with pathology confirmed high grade glioma, graded as World Health Organization (WHO) grade III and IV
- Ability to use a tablet
- Able to adhere to completing surveys at study visits
- English speaking
- Has a caregiver that has provided oral consent to participate in this study
- Insurance accepted at Mayo Clinic Arizona
You may not qualify if:
- Inability to use a tablet
- Inability to adhere to completing surveys at monthly visits
- Unable to speak English
- Lack of a caregiver
- Insurance not accepted at Mayo Clinic Arizona
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Related Publications (1)
Sharma A, Fruth B, Barrera C, Farfour HN, Mrugala MM, Edwin MK, Sloan JA, Porter AB. How much time do we have? Longitudinal perception of prognosis in newly-diagnosed high grade glioma patients and caregivers compared to clinicians. J Neurooncol. 2021 Apr;152(2):313-323. doi: 10.1007/s11060-021-03700-2. Epub 2021 Jan 23.
PMID: 33486637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alyx B Porter Umphrey
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2020
First Posted
November 16, 2020
Study Start
June 13, 2018
Primary Completion
June 13, 2019
Study Completion
August 31, 2020
Last Updated
March 20, 2023
Record last verified: 2023-03