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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

Primary Purpose

Head and Neck Cancer Patients, Late Effects

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
WebCan
Sponsored by
Danish Cancer Society
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Head and Neck Cancer Patients focused on measuring Head and neck cancer, Quality of life, Symptom-burden, Late effects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Danish Cancer Society Research Center, Unit of Suvivorship
  • Herlev Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

WebCan

Usual care

Arm Description

Provides computerized PRO to the treating physician at the point of care

Outcomes

Primary Outcome Measures

Prevalence of late effects

Secondary Outcome Measures

Quality of life
Quality of life at baseline and 12 months follow-up

Full Information

First Posted
February 21, 2013
Last Updated
March 5, 2015
Sponsor
Danish Cancer Society
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Sygekassernes Helsefond
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1. Study Identification

Unique Protocol Identification Number
NCT01803061
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Cancer Society
Collaborators
The Ministry of Science, Technology and Innovation, Denmark, Sygekassernes Helsefond

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer Patients, Late Effects
Keywords
Head and neck cancer, Quality of life, Symptom-burden, Late effects

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WebCan
Arm Type
Experimental
Arm Description
Provides computerized PRO to the treating physician at the point of care
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
WebCan
Intervention Description
Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer
Primary Outcome Measure Information:
Title
Prevalence of late effects
Time Frame
baseline, 6 and 12 months follow-up
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life at baseline and 12 months follow-up
Time Frame
baseline, 6 and 12 months follow-up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoffer Johansen, Professor
Organizational Affiliation
Danish Cancer Society Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Cancer Society Research Center, Unit of Suvivorship
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

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

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