Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: I. Assess feasibility of intra-office Beacon Patient Related Outcomes Quality of Life Scale (PROQOL) assessment of patient and caregiver. II. Assess feasibility of routine (monthly) visits with palliative care specialists. III. Evaluate if overall quality of life of patients with high grade glioma and their caregivers improves with identifying and addressing symptoms and psychosocial concerns identified through the PROQOL tool. IV. Evaluate if overall quality of life of patients with high grade glioma improves further with early integration of palliative care. V. Evaluate if overall quality of life of primary caregivers improves with early integration of palliative care. VI. Compare patient's perception and understanding of disease severity and prognosis with that of the caregivers, and with that of the clinicians. VII. Evaluate variance in prognosis between the neurooncologist and palliative care specialist. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP A: Patients 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: Patients 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: Patients 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.

Official Title
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Pilot Study of Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers

Conditions
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Glioblastoma, Malignant Glioma, WHO Grade III Glioma

Intervention / Treatment
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* Other: Palliative Therapy
* Other: Quality-of-Life Assessment
* Other: Supportive Care
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (visit with neuro-oncologist)<br>Patients 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. | Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Supportive Care<br>* Visit with neuro-oncologist<br>* Other names: Therapy, Supportive;Other: Survey Administration<br>* Complete survey<br>|
| Experimental: Group B (visit with neuro-oncologist and palliative care team)<br>Patients 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. | Other: Palliative Therapy<br>* Visit with palliative care team<br>* Other names: Symptoms Management;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Supportive Care<br>* Visit with neuro-oncologist<br>* Other names: Therapy, Supportive;Other: Survey Administration<br>* Complete survey<br>|
| Active Comparator: Group C (visit with neuro-oncologist, palliative care team)<br>Patients 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. | Other: Palliative Therapy<br>* Visit with palliative care team<br>* Other names: Symptoms Management;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Supportive Care<br>* Visit with neuro-oncologist<br>* Other names: Therapy, Supportive;Other: Survey Administration<br>* Complete survey<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of patients and caregivers | Quality of life is being assessed with a 10 question survey that inquires about overall well being, physical and emotional health, stressors, interaction, and mood. Depending on the question, a higher score may be worse (for example - how would you score your anxiety where 10 is worst; versus how would you score your emotional well being where 10 is worst). The minimum value for each question is 0 and the maximum is 10. This scale has been used in other studies with Beacon. A summary statistic for each patient will be developed depending on the individual responses. Full survey can be reviewed upon request. | Up to 6 months | 
| Discordance in prognostic understanding over time | We will assess how patients, caregivers, and their clinicians differently understand prognosis of the patient in a longitudinal fashion. | Up to 6 months. |