Monitoring patient-reported outcomes in head and neck cancer treatment
Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study
This study is testing if weekly check-ins about side effects from patients with head and neck cancer can help doctors manage their treatment better and improve their quality of life during radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 291 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Aalborg and 5 other locations) |
| Trial ID | NCT03918382 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of weekly electronic reporting of patient-reported outcomes (PROs) on the management of side effects and quality of life in patients undergoing radiotherapy for head and neck cancer. Conducted across six centers in Denmark, it compares standard clinical counseling with and without the integration of PROs to enhance symptom monitoring and treatment decision-making. The study aims to improve the recognition of symptoms and timely management of side effects during treatment for squamous-cell carcinoma of the head and neck.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck who can read and understand Danish.
Not a fit: Patients with serious cognitive deficits or those who have received prior radiotherapy in the same area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life and better management of treatment side effects for patients with head and neck cancer.
How similar studies have performed: Previous studies have indicated that systematic patient assessment of side effects can improve treatment outcomes, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: •Prior radiotherapy in the same area (head and neck)
Where this trial is running
Aalborg and 5 other locations
- Aalborg University Hospital — Aalborg, Denmark (Recruiting)
- Herlev Hospital — Copenhagen, Denmark (Recruiting)
- Rigshoapitalet — Copenhagen, Denmark (Recruiting)
- Zealand Hospital — Næstved, Denmark (Completed)
- Odense University Hospital — Odense, Denmark (Recruiting)
- Aarhus University Hospital — Århus, Denmark (Recruiting)
Study contacts
- Principal investigator: Cecilie Holländer-Mieirtz, MD — Rigshospitalet, Denmark
- Study coordinator: Cecilie Holländer-Mieritz, MD
- Email: cecilie.hollaender-mieritz@regionh.dk
- Phone: +45 35451454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.