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Patient-Reported Outcomes in Head and Neck Cancer (DAHANCA PRO)

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ClinicalTrials.gov Identifier: NCT03918382
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
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
Information provided by (Responsible Party):
Helle Pappot, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Radiotherapy Side Effect Other: Electronic Patient-Reported Outcome Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Management of Side Effects in Head and Neck Cancer by Systematic Use of PRO During Radiotherapy- The National DAHANCA PRO Study
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Quality of life measured by EORTC QLQ C30 [ Time Frame: With in the first 2 months ]
    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.

  2. Quality of life (QOL) measured by EuroQol EQ-5D-5L. [ Time Frame: With in the first 2 months ]
    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.


Secondary Outcome Measures :
  1. DAHANCA toxicity score [ Time Frame: Within the first 4 months ]
    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

  2. Weight loss [ Time Frame: Within the first 4 months ]
    Registration of differences in weight loss in the two groups.

  3. Hospitalization due to toxicity expect tube-feeding and patients reported experience [ Time Frame: Within the first 4 months ]
    Number of hospitalizations reported in the medical record at the control visit 2 months after end af radiotherapy

  4. Compliance to cisplatinum [ Time Frame: Within the first 2 months ]
    Number of participants completing planned Cisplatinum

  5. Time to opioid treatment [ Time Frame: Within the first 3 months ]
    Registration of differences in time to opioid treatment in the two groups

  6. Time to tube-feeding/other feeding [ Time Frame: Within the first 3 months ]
    Registration of differences in time to Time to tube-feeding/other feeding in the two groups



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918382


Contacts
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Contact: Cecilie Holländer-Mieritz, MD +45 35451454 cecilie.hollaender-mieritz@regionh.dk
Contact: Helle Pappot, MD, DMSc +45 35455013 helle.pappot@regionh.dk

Locations
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Denmark
Aalborg University Hospital Not yet recruiting
Aalborg, Denmark
Contact: Maria Andersen, MD         
Herlev Hospital Not yet recruiting
Copenhagen, Denmark
Contact: Elo Andersen, MD         
Rigshoapitalet Not yet recruiting
Copenhagen, Denmark
Contact: Claus A. Kristensen, MD, PhD         
Zealand Hospital Not yet recruiting
Næstved, Denmark
Contact: Mohammad Farhadi, MD         
Odense University Hospital Not yet recruiting
Odense, Denmark
Contact: Jørgen Johansen, MD, PhD         
Aarhus University Hospital Not yet recruiting
Århus, Denmark
Contact: Hanne Primdahl         
Sponsors and Collaborators
Rigshospitalet, Denmark
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
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Principal Investigator: Cecilie Holländer-Mieirtz, MD Rigshospitalet, Denmark

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Responsible Party: Helle Pappot, Clinical Oncologist, Consultant, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03918382     History of Changes
Other Study ID Numbers: DAHANCA PRO
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helle Pappot, Rigshospitalet, Denmark:
Patient-Reported Outcome
Quality of life
Electronic reporting of symptoms
Radiotherapy

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms