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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Other: Electronic Patient-Reported Outcome

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 291
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helle Pappot, MD, DMSc; Phone Number: +45 35455013; Email: helle.pappot@regionh.dk
• Study Contact Backup: Name: Cecilie Holländer-Mieritz, MD; Phone Number: +45 35451454; Email: cecilie.hollaender-mieritz@regionh.dk

Study Locations

• Denmark
  • Aalborg, Denmark
    • Recruiting
    • Aalborg University Hospital
    • Contact: Maria Andersen, MD
  • Copenhagen, Denmark
    • Recruiting
    • Herlev Hospital
    • Contact: Elo Andersen, MD
  • Copenhagen, Denmark
    • Recruiting
    • Rigshoapitalet
    • Contact: Claus A. Kristensen, MD, PhD
  • Næstved, Denmark
    • Completed
    • Zealand Hospital
  • Odense, Denmark
    • Recruiting
    • Odense University Hospital
    • Contact: Jørgen Johansen, MD, PhD
  • Århus, Denmark
    • Recruiting
    • Aarhus University Hospital
    • Contact: Hanne Primdahl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; First 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.
Experimental: PRO group; Second 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.	Other: Electronic Patient-Reported Outcome; Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.; Other Names: Real-time guidance of patients when symptom reporting; Patient Self-Reporting of Symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Weight loss	Registration of differences in weight loss in the two groups.	Within the first 4 months
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
Compliance to cisplatinum	Number of participants completing planned Cisplatinum	Within the first 2 months
Time to opioid treatment	Registration of differences in time to opioid treatment in the two groups	Within the first 3 months
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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Odense University Hospital; Zealand University Hospital; Aarhus University Hospital; University of Copenhagen; Danish Cancer Society; Herlev Hospital; Aalborg University Hospital; Danish Head and Neck Cancer Group; Danish Comprehensive Cancer Center
• Investigators: Principal Investigator: Cecilie Holländer-Mieirtz, MD, Rigshospitalet, Denmark

Publications and helpful links

Helpful Links

• Study protocol article

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: April 10, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Quality of life; Radiotherapy; Patient-Reported Outcome; Electronic reporting of symptoms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: DAHANCA PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No