Patient-Reported Outcomes in Head and Neck Cancer
DAHANCA PRO
Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study
1 other identifier
interventional
291
1 country
6
Brief Summary
Weekly electronic reporting of patient-reported outcomes will be tested in a national trial in participants undergoing radiotherapy for head and neck cancer. The study is a national study under the Danish Head and Neck Cancer Group (DAHANCA) and all 6 centers in Denmark will participate. The clinical endpoints will be:
- Quality of life
- Objective toxicity score (DAHANCA)
- Opioid treatment
- Tube feeding
- Weight loss
- Hospitalization
- Compliance to treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Jun 2019
Longer than P75 for not_applicable head-and-neck-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
June 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2024
CompletedOctober 27, 2023
October 1, 2023
4.7 years
April 10, 2019
October 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Quality of life measured by EORTC QLQ C30
Registration of differences in quality of life between the two groups in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.
With in the first 2 months
Quality of life (QOL) measured by EuroQol EQ-5D-5L.
EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention. The scores will be presented graphically in separate figures. Differences between the groups will be tested using t-test and analysis of covariance.
With in the first 2 months
Secondary Outcomes (6)
DAHANCA toxicity score
Within the first 4 months
Weight loss
Within the first 4 months
Hospitalization due to toxicity expect tube-feeding and patients reported experience
Within the first 4 months
Compliance to cisplatinum
Within the first 2 months
Time to opioid treatment
Within the first 3 months
- +1 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONFirst phase. 97 participants. This group will continue standard procedure regarding side effect registration and handling. When the 97 patients have been included and have finished their radiotherapy the second phase will be initiated.
PRO group
EXPERIMENTALSecond phase. 194 participants. This group will be assigned to the intervention which is weekly electronic Patient-Reported Outcomes. Patients report the symptoms (PRO) on a tablet before each weekly control visit. The clinician will use the patients PRO answers as part of the consultation. The PRO symptoms consist of head and neck relevant items fra PRO-CTCAE™ (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) and EORTC (European Organisation for Research and Treatment of Cancer) item library.
Interventions
Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.
Eligibility Criteria
You may qualify if:
- Primary or post-operative curative radiotherapy (photons) plus/minus concomitant Cisplatinum for squamous-cell carcinoma of the head and neck (HNSCC)
- No serious cognitive deficits
- Read and understand Danish
You may not qualify if:
- Prior radiotherapy in the same area (head and neck)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Danish Comprehensive Cancer Centercollaborator
- Danish Cancer Societycollaborator
- University of Copenhagencollaborator
- Danish Head and Neck Cancer Groupcollaborator
- Herlev Hospitalcollaborator
- Zealand University Hospitalcollaborator
- Odense University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (6)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Herlev Hospital
Copenhagen, Denmark
Rigshoapitalet
Copenhagen, Denmark
Zealand Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cecilie Holländer-Mieirtz, MD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Oncologist, Consultant, DMSc
Study Record Dates
First Submitted
April 10, 2019
First Posted
April 17, 2019
Study Start
June 13, 2019
Primary Completion
March 1, 2024
Study Completion
August 1, 2024
Last Updated
October 27, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share