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Head and Neck CancerDAHANCA PRONCT03918382

Patient-Reported Outcomes in Head and Neck Cancer

A study testing Electronic Patient-Reported Outcome in people with Head and Neck Cancer and Radiotherapy Side Effect, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Electronic Patient-Reported Outcome
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
6 sitesDenmark
Study dates
13 Jun 2019to 1 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • •Prior radiotherapy in the same area (head and neck)

Trial locations and contacts

6 sites in 1 country.

Cecilie Holländer-Mieritz, MD contact

+45 35451454

cecilie.hollaender-mieritz@regionh.dk

Helle Pappot, MD, DMSc contact

+45 35455013

helle.pappot@regionh.dk

6 sites in 1 country

Denmark6 sites, 5 recruiting

  • Aalborg University Hospital

    Aalborg

    Maria Andersen, MD

    Recruiting

  • Aarhus University Hospital

    Aarhus

    Hanne Primdahl

    Recruiting

  • Herlev Hospital

    Copenhagen

    Elo Andersen, MD

    Recruiting

  • Rigshoapitalet

    Copenhagen

    Claus A. Kristensen, MD, PhD

    Recruiting

  • Zealand Hospital

    Næstved

    Completed

  • Odense University Hospital

    Odense

    Jørgen Johansen, MD, PhD

    Recruiting

Other trials in Denmark

About this study

Official title: 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
Read the 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.

Being tested
Electronic Patient-Reported Outcome
Keywords
Patient-Reported Outcome, Quality of life, Electronic reporting of symptoms, Radiotherapy
Medical subject headings
Head and Neck Neoplasms, Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electronic Patient-Reported OutcomeOther

    Also called Real-time guidance of patients when symptom reporting, Patient Self-Reporting of Symptoms

    Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.

Study groups in NCT03918382
Study groupRoleWhat they receive
Control groupNo interventionFirst 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.
PRO groupExperimentalSecond 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.
Receives: Other: Electronic Patient-Reported Outcome

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: With in the first 2 months

  2. 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.

    Measured: With in the first 2 months

Secondary outcomes (6)

  1. 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

    Measured: Within the first 4 months

  2. Weight loss

    Registration of differences in weight loss in the two groups.

    Measured: Within the first 4 months

  3. 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

    Measured: Within the first 4 months

  4. Compliance to cisplatinum

    Number of participants completing planned Cisplatinum

    Measured: Within the first 2 months

  5. Time to opioid treatment

    Registration of differences in time to opioid treatment in the two groups

    Measured: Within the first 3 months

  6. Time to tube-feeding/other feeding

    Registration of differences in time to Time to tube-feeding/other feeding in the two groups

    Measured: Within the first 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2019
  2. Study start13 Jun 2019
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion1 Aug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
291 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03918382
Sponsor's protocol ID
DAHANCA PRO
Acronym
DAHANCA PRO
Status last verified
Oct 2023
First submitted
10 Apr 2019
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Electronic Patient-Reported Outcome in people with Head and Neck Cancer and Radiotherapy Side Effect, run by Copenhagen University Hospital, Rigshospitalet at 6 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Cecilie Holländer-Mieritz, MD (+45 35451454, cecilie.hollaender-mieritz@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life measured by EORTC QLQ C30 (time frame: With in the first 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03918382.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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