Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625047
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neuro-Oncology Anywhere 242 Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None