Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Pilot Study of Multi-platform Assessment of Radiation Toxicity M-PART in Head and Neck Cancer Patients Treated With KeraStat Cream for Acute Radiation Dermatitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the ability of a mobile device application MyCap to collect patient information about their radiation skin rash in patients with head and neck cancer being treated with radiation therapy
Detailed Description:
Primary Objective To determine the feasibility of M-PART for the assessment of acute radiation dermatitis in patients treated with radiotherapy for head and neck cancer via MyCap
Secondary Objectives
To assess agreement between site clinician-rated CTCAE G2 radiation dermatitis with moist desquamation and patient-reported moist desquamation a and b above
To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review
To assess agreement between clinician-rated radiation dermatitis grading central review of patient-submitted photographs and central review of standardized clinic photographs methods a c and d above
To measure the level of interval ie optional engagement in between scheduled collection patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology
To measure patient and research staff satisfaction perceptions and preferences with regard to the M-PART data collection framework
Secondary Objectives
To assess agreement between site clinician-rated CTCAE G2 radiation dermatitis with moist desquamation and patient-reported moist desquamation a and b above
To assess the proportion of patient-submitted photographs of skin in the irradiated area that are evaluable for radiation dermatitis assessments by central review
To assess agreement between clinician-rated radiation dermatitis grading central review of patient-submitted photographs and central review of standardized clinic photographs methods a c and d above
To measure the level of interval ie optional engagement in between scheduled collection patient engagement in the collection of radiation toxicity outcomes using the M-PART methodology
To measure patient and research staff satisfaction perceptions and preferences with regard to the M-PART data collection framework
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA012197 | NIH | None | httpsreporternihgovquickSearchP30CA012197 |