Patient-Reported Outcomes in Head and Neck Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Head and Neck Cancer
- Radiotherapy Side Effect
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: A prospective nation-wide, sequential cohort study. First phase control group. 97 participants. No Intervention: Standard of care.This arm will continue standard procedure regarding side effect registration and handling. Second phase. PRO group. 194 participants. Intervention: Active use of electronic patient-reported outcomes.This arm will be assigned to intervention by weekly electronic reporting of side effects and quality of life. Masking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
There is a high level of evidence for improved disease control in head and neck cancer (HNC) using regimens with accelerated radiotherapy and concomitant chemotherapy. These intense regimens can result in severe acute and late side effect. The standard approach for documenting symptomatic adverse ev...
There is a high level of evidence for improved disease control in head and neck cancer (HNC) using regimens with accelerated radiotherapy and concomitant chemotherapy. These intense regimens can result in severe acute and late side effect. The standard approach for documenting symptomatic adverse events (AEs) in cancer clinical trials involves investigator reporting using the National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE). In Denmark, the Danish Head and Neck Cancer Group (DAHANCA) toxicity score has been used as an instrument in assessing objective treatment induced toxicity. New research in other cancer treatments indicate, that systematic patient assessment of side effects may improve treatment outcome. Patient Reported Outcomes (PROs) can be used for symptom monitoring. Interactive use of PRO may secure early recognition of specific symptoms in the individual patient and timely management of side effects. This trial it is a prospective nationwide, single armed sequential cohort study will investigate the effects of active use of PROs in clinical counselling and decision making during primary or post-operative curative radiotherapy for squamous-cell carcinoma of the head and neck (HNSCC). It will investigate quality of life and the management of side effects in standard clinical counselling (control group) versus standard clinical counselling plus the PRO (PRO group). The EORTC QLQ-C30 (quality of life questionnaire) and EQ-D5-L5 will be answered in both groups. In the PRO group the participants will be asked to complete the electronic PRO (PRO CTCAE™ HNC relevant items supplemented by HNC specific items fra the EORTC library) weekly. The electronic PRO questionnaire is designed to give feedback to treating physician and nurses at visits during and shortly after radiotherapy.
Tracking Information
- NCT #
- NCT03918382
- Collaborators
- Danish Comprehensive Cancer Center
- Danish Cancer Society
- University of Copenhagen
- Danish Head and Neck Cancer Group
- Herlev Hospital
- Zealand University Hospital
- Odense University Hospital
- Aalborg University Hospital
- Aarhus University Hospital
- Investigators
- Principal Investigator: Cecilie Holländer-Mieirtz, MD Rigshospitalet, Denmark
Get Well Soon