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Trial Title:
Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
NCT ID:
NCT06625047
Condition:
Astrocytoma, IDH-Mutant
Glioblastoma
Glioma
Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
Conditions: Official terms:
Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Temozolomide
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Assessment
Description:
Complete in-person assessment visits
Arm group label:
Health services research (temozolomide, telehealth, in-person)
Other name:
Assess
Other name:
Study Assessment
Other name:
Study Observation
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Health services research (temozolomide, telehealth, in-person)
Intervention type:
Other
Intervention name:
Telemedicine Visit
Description:
Complete telehealth assessment visits
Arm group label:
Health services research (temozolomide, telehealth, in-person)
Other name:
Telemedicine Encounter
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Given PO
Arm group label:
Health services research (temozolomide, telehealth, in-person)
Other name:
CCRG-81045
Other name:
Gliotem
Other name:
Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-
Other name:
M & B 39831
Other name:
M and B 39831
Other name:
Methazolastone
Other name:
RP-46161
Other name:
SCH 52365
Other name:
Temcad
Other name:
Temizole
Other name:
Temodal
Other name:
Temodar
Other name:
Temomedac
Other name:
TMZ
Summary:
This phase IV trial compares patient satisfaction with telehealth versus in-person
neuro-oncology assessments among glioma patients receiving oral chemotherapy. Gliomas are
the most common primary central nervous system cancer and are associated with a high
symptom burden, such as drowsiness, fatigue, memory difficulty, and difficulty
communicating. Care at a high volume center is associated with an overall survival
benefit, however, many patients may have physical or financial difficulties preventing
access to these centers. Telehealth visits use computers, cameras, videoconferencing, the
internet, satellite, and wireless communications to deliver healthcare, while in-person
visits require the interaction to take place in the physical presence of someone else.
Telehealth neuro-oncology assessments may be preferable compared to in-person assessments
in glioma patients receiving oral chemotherapy.
Detailed description:
PRIMARY OBJECTIVE:
I. Assess patient satisfaction with care delivered as measured by institutional
Press-Ganey survey scores obtained following telehealth and in-person assessments.
SECONDARY OBJECTIVES:
I. Assess completion rate of planned oral chemotherapy among patients with glioma within
28 days of telehealth visits compared to within 28 days of in-person visits.
II. Assess preference for telehealth versus in-person neuro-oncologic evaluations among
patients with glioma receiving oral chemotherapy.
III. Assess acute care utilization days, defined as emergency department evaluations and
days of hospitalization within 28 days of telehealth visits compared to within 28 days of
in-person visits.
IV. Assess neurologic impairment as measured by the Neurologic Assessment in
Neuro-Oncology (NANO) scale will be measured at each visit with rate of neurological
decline within the 28 days following telehealth assessments compared to neurological
decline within the 28 days following in-person assessments.
V. Assess quality of life as measured by the European Organization for the Research and
Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), a 30-item
questionnaire that is used to assess the quality of life of cancer patients, completed at
baseline and at the end of each chemotherapy cycle.
OUTLINE:
Patients receive temozolomide orally (PO) once daily (QD) on days 1-5 of each cycle.
Cycles repeat every 28 days for up to 6 cycles per standard of care in the absence of
disease progression or unacceptable toxicity. Patients complete alternating telehealth
assessment visits and in-person assessment visits after each cycle of treatment.
After completion of study intervention, patients are followed up at 30 days.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma
(GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are
eligible
- Patients eligible to receive temozolomide as standard of care adjuvant therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND
Karnofsky performance status (KPS) of ≥ 60
- Expected survival ≥ 6 months in the opinion of treatment team
- Willing and able to adhere with the protocol for the duration of the study including
undergoing treatment, and attending scheduled visits, and examinations
- Participants who do not have devices that will permit telehealth visits will be
provided such tablet devices to facilitate appointments for the duration of the
study
- Participants who do not have financial resources to travel for in-person visits will
be provided assistance for cost of travel
- Ability to complete patient experience surveys by the participant with or without
assistance from their caregiver
Exclusion Criteria:
- Uncontrolled and/or intercurrent illness or other condition which limits safety of
or compliance with study proceedings
- Pregnant or nursing, imprisoned, or lacking capacity for understanding
- Unable to swallow tablets or at risk for impaired absorption of oral medication
- Known hypersensitivity or allergy to temozolomide
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Ugur T. Sener, MD
Email:
Principal Investigator
Start date:
October 7, 2024
Completion date:
March 31, 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06625047
https://www.mayo.edu/research/clinical-trials
