Clinical trial NCT03918382: Patient-Reported Outcomes in Head and Neck Cancer
Official title: Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Radiotherapy Side Effect
Keywords: Patient-Reported Outcome
Quality of life
Electronic reporting of symptoms
Radiotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Comprehensive Cancer Center
name: Danish Cancer Society
name: University of Copenhagen
name: Danish Head and Neck Cancer Group
name: Herlev Hospital
name: Zealand University Hospital
name: Odense University Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
First posted: 2019-04-17
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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)

Primary outcomes:
measure: Quality of life measured by EORTC QLQ C30
timeFrame: With in the first 2 months
measure: Quality of life (QOL) measured by EuroQol EQ-5D-5L.
timeFrame: With in the first 2 months
Secondary outcomes:
measure: DAHANCA toxicity score
timeFrame: Within the first 4 months
measure: Weight loss
timeFrame: Within the first 4 months
measure: Hospitalization due to toxicity expect tube-feeding and patients reported experience
timeFrame: Within the first 4 months
measure: Compliance to cisplatinum
timeFrame: Within the first 2 months
measure: Time to opioid treatment
timeFrame: Within the first 3 months
measure: Time to tube-feeding/other feeding
timeFrame: Within the first 3 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Herlev Hospital
city: Copenhagen
country: Denmark
facility: Rigshoapitalet
city: Næstved
country: Denmark
facility: Zealand Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Århus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Cecilie Holländer-Mieirtz, MD
role: PRINCIPAL_INVESTIGATOR
References: