Telemedicine Rash Evaluation and Assessment of Toxicity in Skin in Acute Oncology and Haematology Care: A Pilot Study (TREATS)
TREATS: Telemedicine Rash Evaluation and Assessment of Toxicity in Skin in Acute Oncology and Haematology Care: A Pilot Study
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Margaret Burke
- Phone Number: 00353 (0)87 0479985
- Email: margaret1.burke@hse.ie
Study Locations
-
-
Sligo
-
Sligo, Sligo, Ireland, f91h684
- Sligo University Hospital
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Participants must meet all of the following criteria:
- Adult oncology or haematology patients currently receiving systemic anti-cancer therapy (SACT).
- New-onset dermatologic toxicity consistent with a recognised adverse effect of the administered SACT.
- Skin toxicity severity graded ≤ Grade 2 in accordance with UKONS assessment criteria.
- Clinically stable condition not requiring urgent in-person evaluation.
- Access to, and ability to use, a smartphone or computer with adequate internet connectivity to participate in telemedicine consultations.
Exclusion Criteria: Participants will be excluded if any of the following criteria apply:
- Skin toxicity graded ≥ Grade 3 according to UKONS assessment criteria.
- Clinical status requiring urgent or immediate face-to-face medical assessment.
- Dermatologic toxicity that is atypical, unexpected, or not consistent with known SACT-related adverse effects.
- Inability to access or effectively use the required telemedicine technology.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Remote tele medicine assessment
use of telemedicine
|
SOC is face to face assessment-this study aims to use telemedecine toassess Treatment related skin disorders
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time to clinical resolution
Time Frame: 6 weeks
|
Number of days from first AHOS contact to documented resolution (Grade 0-1).
|
6 weeks
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Escalation in person review
Time Frame: 6 weeks
|
Proportion of telemedicine patients requiring:
|
6 weeks
|
|
treatment modification reat
Time Frame: 6 weeks
|
Proportion of telemedicine patients requiring:
|
6 weeks
|
|
unscheduled acute contact
Time Frame: 6 weeks
|
Number of unplanned re-contacts with AHOS
|
6 weeks
|
|
Patient-Reported Endpoints -Quality of Life (QoL) and patient satisfaction
Time Frame: 6 weeks
|
Instrument: QLQ administered:
|
6 weeks
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 1067SUHREC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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