- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07426874
eHealth Support Tool to Improve Quality of Life in Head and Neck Cancer Survivors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Head and neck cancer (HNC) survivors experience significant long-term physical, functional, and psychosocial sequelae including dysphagia, speech impairment, fatigue, pain, and psychological distress. Traditional follow-up models rely on periodic clinic visits and may not adequately support self-management.
This study involves three phases:
Development of a co-designed eHealth support platform.
Implementation of the intervention within survivorship care pathways.
Evaluation of clinical effectiveness using patient-reported outcomes and healthcare utilization metrics.
The intervention integrates:
Symptom tracking Educational resources Self-management tools Structured nurse-guided follow-up
The primary hypothesis is that structured digital survivorship support will improve global quality of life compared to usual follow-up care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Beaumont, Ireland, D09V2N0
- Beaumont RCSI Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adults ≥18 years Diagnosed with head and neck cancer Completed primary treatment (surgery, radiotherapy, chemotherapy or combination) Within 12 months post-treatment Access to smartphone/tablet/internet Able to provide informed consent
Exclusion Criteria:
Recurrent or metastatic disease requiring active treatment Significant cognitive impairment Inability to use digital device Non-English speakers (if tool not multilingual)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Intervention Name: eHealth Survivorship Support Tool Description: A digital platform including: Symptom monitoring Educational modules Self-management guidance Nurse-supported remote follow-up |
A digital platform including: Symptom monitoring Educational modules Self-management guidance Nurse-supported remote follow-up |
|
Active Comparator: Control
Participants receive standard survivorship follow-up as per institutional guidelines.
|
Standard follow up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life EORTC QLQ-C30 (Global Health Status scale)
Time Frame: Baseline, 3 months, 6 months
|
Measurement Tool: EORTC QLQ-C30 (Global Health Status scale) Time Frame: Baseline, 3 months, 6 months
|
Baseline, 3 months, 6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BH-REC-eHealth-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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