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

March 16, 2023 updated by: Alyx Porter, M.D., Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (visit with neuro-oncologist)
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
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Complete survey
Other: Supportive Care
Visit with neuro-oncologist
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Experimental: Group B (visit with neuro-oncologist and palliative care team)
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Complete survey
Other: Supportive Care
Visit with neuro-oncologist
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Palliative Therapy
Visit with palliative care team
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management
Active Comparator: Group C (visit with neuro-oncologist, palliative care team)
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: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Survey Administration
Complete survey
Other: Supportive Care
Visit with neuro-oncologist
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Other: Palliative Therapy
Visit with palliative care team
Other Names:
  • Symptom Management
  • Comfort Care
  • Palliative Care
  • Palliative Treatment
  • PA-Palliative Therapy
  • palliation
  • Palliative
  • Symptoms Management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in feasibility of using the Beacon Patient Reported Outcomes Quality of Life Scale (PROQOL)
Time Frame: monthly for six months
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
Time Frame: monthly for 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months.
We will assess how patients, caregivers, and their clinicians differently understand prognosis of the patient in a longitudinal fashion.
Up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Alyx B Porter Umphrey, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2018

Primary Completion (Actual)

June 13, 2019

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

November 10, 2020

First Submitted That Met QC Criteria

November 10, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-011342 (Other Identifier: Mayo Clinic in Arizona)
  • NCI-2020-07998 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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