Early Integration of Palliative Care Using the BEACON PROQOL in Patients With High Grade Glioma and Their Caregivers
NCT ID: NCT04630379
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-06-13
2020-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Quality-of-Life Assessment
Ancillary studies
Supportive Care
Visit with neuro-oncologist
Survey Administration
Complete survey
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.
Palliative Therapy
Visit with palliative care team
Quality-of-Life Assessment
Ancillary studies
Supportive Care
Visit with neuro-oncologist
Survey Administration
Complete survey
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.
Palliative Therapy
Visit with palliative care team
Quality-of-Life Assessment
Ancillary studies
Supportive Care
Visit with neuro-oncologist
Survey Administration
Complete survey
Interventions
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Palliative Therapy
Visit with palliative care team
Quality-of-Life Assessment
Ancillary studies
Supportive Care
Visit with neuro-oncologist
Survey Administration
Complete survey
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 adhere to completing surveys at monthly visits
* Unable to speak English
* Lack of a caregiver
* Insurance not accepted at Mayo Clinic Arizona
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Alyx Porter, M.D.
Principal Investigator
Principal Investigators
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Alyx B Porter Umphrey
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Countries
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References
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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.
Other Identifiers
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NCI-2020-07998
Identifier Type: REGISTRY
Identifier Source: secondary_id
17-011342
Identifier Type: OTHER
Identifier Source: secondary_id
17-011342
Identifier Type: -
Identifier Source: org_study_id
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