Skip to main content
OpenTrials
Completed

NCT Number: NCT04630379

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Glioblastoma Astrocytoma Glioma Malignant Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors WHO Grade III Glioma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Palliative Therapy

Other

Visit with palliative care team

Other names: Comfort Care, PA-Palliative Therapy, palliation, Palliative, Palliative Care, Palliative Treatment, Symptom Management, Symptoms Management

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Supportive Care

Other

Visit with neuro-oncologist

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Survey Administration

Other

Complete survey

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 16, 2020
Registry last updated
Mar 20, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.