Clinical trial NCT06625047: Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
Official title: Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Astrocytoma, IDH-Mutant
Glioblastoma
Glioma
Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 while on study 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.

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

Primary outcomes:
measure: Patient satisfaction with care delivered
timeFrame: Up to 6 months
Secondary outcomes:
measure: Completion rate of planned oral chemotherapy
timeFrame: Within 28 days of telehealth or in-person visits and up to 6 months
measure: Preference for telehealth vs. in-person neuro-oncologic evaluations
timeFrame: Up to 6 months
measure: Acute care utilization days
timeFrame: Within 28 days of telehealth or in-person visits, up to 6 months
measure: Neurologic impairment - NANO
timeFrame: Up to 6 months
measure: Change in quality of life - EORTC QLQ-C30
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ugur T. Sener, MD
role: PRINCIPAL_INVESTIGATOR
References: