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

Mayo Clinic

Status: Completed

Conditions: Glioblastoma; WHO Grade III Glioma; Malignant Glioma

Treatments: Other: Quality-of-Life Assessment; Other: Supportive Care; Other: Survey Administration; Other: Palliative Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04630379

NCI-2020-07998 (Registry Identifier)

17-011342 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Group A (visit with neuro-oncologist)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Supportive Care

Other: Quality-of-Life Assessment

Group B (visit with neuro-oncologist and palliative care team)

Experimental group

Description:

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.

Treatment:

Other: Palliative Therapy

Other: Survey Administration

Other: Supportive Care

Other: Quality-of-Life Assessment

Group C (visit with neuro-oncologist, palliative care team)

Active Comparator group

Description:

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.

Treatment:

Other: Palliative Therapy

Other: Survey Administration

Other: Supportive Care

Other: Quality-of-Life Assessment