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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06625047.
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.
Trial PhasePhase IV
Trial Typehealth services research
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorUgur Sener
