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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04630379
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Alyx B Porter Umphrey
Principal Investigator Affiliation Mayo Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma, Malignant Glioma, WHO Grade III Glioma
Additional Details

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.

Arms & Interventions

Arms

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.

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.

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.

Interventions

Other: - Palliative Therapy

Visit with palliative care team

Other: - Quality-of-Life Assessment

Ancillary studies

Other: - Supportive Care

Visit with neuro-oncologist

Other: - Survey Administration

Complete survey

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Arizona, Scottsdale, Arizona

Status

Address

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259

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