Patient-Reported Outcomes in Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— DAHANCA PRO  

Official title:

Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03918382
• Other study ID #: DAHANCA PRO
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2019
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: Cecilie Holländer-Mieritz, MD
• Phone: +45 35451454
• Email: cecilie.hollaender-mieritz[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 291
• Est. completion date: August 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Radiotherapy Side Effect

Intervention

Other:
• Electronic Patient-Reported Outcome
Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Aarhus University Hospital	Århus
Denmark	Herlev Hospital	Copenhagen
Denmark	Rigshoapitalet	Copenhagen
Denmark	Zealand Hospital	Næstved
Denmark	Odense University Hospital	Odense

Sponsors (10)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Danish Cancer Society, Danish Comprehensive Cancer Center, Danish Head and Neck Cancer Group, Herlev Hospital, Odense University Hospital, University of Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	DAHANCA toxicity score	DAHANCA toxicity score is an objective grading of the patients symptoms by the clinician. Scale 0-4, where 0 is no/nothing and 4 is severe. Registration of differences in DAHANCA toxicity score and electronic PRO	Within the first 4 months
Secondary	Weight loss	Registration of differences in weight loss in the two groups.	Within the first 4 months
Secondary	Hospitalization due to toxicity expect tube-feeding and patients reported experience	Number of hospitalizations reported in the medical record at the control visit 2 months after end af radiotherapy	Within the first 4 months
Secondary	Compliance to cisplatinum	Number of participants completing planned Cisplatinum	Within the first 2 months
Secondary	Time to opioid treatment	Registration of differences in time to opioid treatment in the two groups	Within the first 3 months
Secondary	Time to tube-feeding/other feeding	Registration of differences in time to Time to tube-feeding/other feeding in the two groups	Within the first 3 months

External Links

•   Study protocol article