GlioblastomaNCT04630379
Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers
A study testing Palliative Therapy, Quality-of-Life Assessment and Supportive Care in people with Glioblastoma and Malignant Glioma, run by Mayo Clinic at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Malignant Glioma, WHO Grade III Glioma
- What is being tested?
- Palliative Therapy, Quality-of-Life Assessment and Supportive Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2018to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- 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.
- Conditions
- Glioblastoma, Malignant Glioma, WHO Grade III Glioma
- Being tested
- Palliative Therapy, Quality-of-Life Assessment, Supportive Care, Survey Administration
- Medical subject headings
- Glioblastoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative TherapyOther
Also called Comfort Care, PA-Palliative Therapy, palliation, Palliative
Visit with palliative care team
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Visit with neuro-oncologist
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Group A (visit with neuro-oncologist) | Experimental | 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. Receives: Other: Quality-of-Life Assessment; Other: Supportive Care; Other: Survey Administration |
| Group B (visit with neuro-oncologist and palliative care team) | Experimental | 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. Receives: Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Supportive Care; Other: Survey Administration |
| Group C (visit with neuro-oncologist, palliative care team) | Active comparator | 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. Receives: Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Supportive Care; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: monthly for 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start13 Jun 2018
- Primary completion13 Jun 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Alyx Porter, M.D., Mayo Clinic
- Investigators
- Alyx B Porter Umphrey, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04630379
- Sponsor's protocol ID
- 17-011342
- Other IDs
- NCI-2020-07998, 17-011342
- Status last verified
- Mar 2023
- First submitted
- 10 Nov 2020
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharma A, Fruth B, Barrera C, Farfour HN, Mrugala MM, Edwin MK, Sloan JA, Porter AB. How much time do we have? Longitudinal perception of prognosis in newly-diagnosed high grade glioma patients and caregivers compared to clinicians. J Neurooncol. 2021 Apr;152(2):313-323. doi: 10.1007/s11060-021-03700-2. Epub 2021 Jan 23.
PubMed 33486637
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers
- ClinicalTrials.gov ID
- NCT04630379
- Acronym / sponsor ID
- 17-011342
- Conditions
- Glioblastoma, Malignant Glioma, WHO Grade III Glioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 16 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (visit with neuro-oncologist) | Experimental | Other: Quality-of-Life Assessment, Other: Supportive Care, Other: Survey AdministrationPatients 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 (visit with neuro-oncologist and palliative care team) | Experimental | Other: Palliative Therapy, Other: Quality-of-Life Assessment, Other: Supportive Care, Other: Survey AdministrationPatients 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 (visit with neuro-oncologist, palliative care team) | Active comparator | Other: Palliative Therapy, Other: Quality-of-Life Assessment, Other: Supportive Care, Other: Survey AdministrationPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative TherapyAlso: Comfort Care, PA-Palliative Therapy, palliation, PalliativeVisit with palliative care team | Other | Group B (visit with neuro-oncologist and palliative care team), Group C (visit with neuro-oncologist, palliative care team) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group A (visit with neuro-oncologist), Group B (visit with neuro-oncologist and palliative care team), Group C (visit with neuro-oncologist, palliative care team) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveVisit with neuro-oncologist | Other | Group A (visit with neuro-oncologist), Group B (visit with neuro-oncologist and palliative care team), Group C (visit with neuro-oncologist, palliative care team) |
| Survey AdministrationComplete survey | Other | Group A (visit with neuro-oncologist), Group B (visit with neuro-oncologist and palliative care team), Group C (visit with neuro-oncologist, palliative care team) |
Primary outcome
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.
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.
2 secondary outcomes
Quality of life of patients and caregivers
Time frame: Up to 6 months
Discordance in prognostic understanding over time
Time frame: Up to 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Derived from this study: PubMed 33486637Sharma A, Fruth B, Barrera C, Farfour HN, Mrugala MM, Edwin MK, Sloan JA, Porter AB. How much time do we have? Longitudinal perception of prognosis in newly-diagnosed high grade glioma patients and caregivers compared to clinicians. J Neurooncol. 2021 Apr;152(2):313-323. doi: 10.1007/s11060-021-03700-2. Epub 2021 Jan 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyx B Porter Umphrey principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palliative Therapy, Quality-of-Life Assessment and Supportive Care in people with Glioblastoma and Malignant Glioma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in feasibility of using the Beacon Patient Reported Outcomes Quality of Life Scale (PROQOL) (time frame: monthly for six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04630379, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.