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Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803061
First Posted: March 4, 2013
Last Update Posted: March 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Sygekassernes Helsefond
Information provided by (Responsible Party):
Trille Kjær, Danish Cancer Society
  Purpose

Patient-reported information on outcomes such as symptom-burden and health-related quality of life (QoL) is regarded as a useful tool to improve quality of care in clinical cancer research. However, integrating patient-reported information in the routine clinical practice is often difficult due to excessive time use and practical barriers. Electronic data acquisitions, where the treating physician has immediately access to the patient-reported data in the subsequent consultation, have been shown to be beneficial in the everyday clinical decision making.

The aim of this study is to develop and test a computer-based patient-reported assessment tool that will assist the clinicians in tracking long term and late effects in head and neck cancer patients and investigate if the tool leads to improved symptom assessment of a range of head and neck cancer specific symptoms, which again may lead to improved symptom control and enhanced quality of life in the patients.

Patients with a diagnosis of head and neck cancer attending the oncology outpatient clinics at Herlev Hospital and physicians and nurses who work at the clinic will be invited to participate. The assessment tool will be developed with inspiration from prior international studies of symptom assessment in head and neck cancer patients and tailored so that it will fit into a Danish context. The tool will be tested in a controlled intervention study. In the intervention group, patients will complete the assessment tool in the patients waiting area prior to every scheduled consultation. The result will then be printed and provided to the treating physician. In the control group, the patients will complete the assessment tool prior to consultations. However, the data will not be provided to the physicians at any time.

To assess the impact of the tool on number of symptoms addressed during consultations and patients' overall quality of life, medical records will be reviewed for before start of intervention and again at 6 and 12 months follow-up. The patients will also complete the EORTC QLQ-C30 and the EORTC QLQ-H&N35 at baseline and at 6 and 12 months follow-up. Furthermore, we will conduct a qualitative evaluation (semi structured interview and participant observations) of attitudes among clinicians and patients regarding the use of tool at the point of care.


Condition Intervention
Head and Neck Cancer Patients Late Effects Behavioral: WebCan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care

Resource links provided by NLM:


Further study details as provided by Trille Kjær, Danish Cancer Society:

Primary Outcome Measures:
  • Prevalence of late effects [ Time Frame: baseline, 6 and 12 months follow-up ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: baseline, 6 and 12 months follow-up ]
    Quality of life at baseline and 12 months follow-up


Estimated Enrollment: 300
Study Start Date: September 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WebCan
Provides computerized PRO to the treating physician at the point of care
Behavioral: WebCan
Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer
No Intervention: Usual care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prevalent recurrence free patients with cancers in the tongue, oral cavity, pharynx and larynx attending the oncology clinic at Herlev Hospital, Herlev, Denmark. 9 months to 5 years after end of treatment

Exclusion Criteria:

  • Patients with recurrence of their cancers and patients still in treatment.
  Contacts and Locations
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): NCT01803061


Locations
Denmark
Danish Cancer Society Research Center, Unit of Suvivorship
Copenhagen, Denmark, DK-2100
Herlev Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Danish Cancer Society
The Ministry of Science, Technology and Innovation, Denmark
Sygekassernes Helsefond
Investigators
Study Director: Christoffer Johansen, Professor Danish Cancer Society Research Center
  More Information

Responsible Party: Trille Kjær, Phd student, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT01803061     History of Changes
Other Study ID Numbers: WebCan
First Submitted: February 21, 2013
First Posted: March 4, 2013
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Trille Kjær, Danish Cancer Society:
Head and neck cancer
Quality of life
Symptom-burden
Late effects

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