Late Effects Clinical Trial
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
Verified date | March 2015 |
Source | Danish Cancer Society |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Dataprotection Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Cancer Society Research Center, Unit of Suvivorship | Copenhagen | |
Denmark | Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Danish Cancer Society | Sygekassernes Helsefond, The Ministry of Science, Technology and Innovation, Denmark |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prevalence of late effects | baseline, 6 and 12 months follow-up | No | |
Secondary | Quality of life | Quality of life at baseline and 12 months follow-up | baseline, 6 and 12 months follow-up | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04811794 -
Young Survivors at Kantonsspital Aarau, Switzerland
|
||
Recruiting |
NCT04671693 -
A Post-treatment Program to Identify and Manage Complications Related to Oncology or Hematology Treatments in Cancer Survivors.
|
N/A | |
Completed |
NCT01724333 -
International Validation of the QLQ-OH17 for Oral Health
|
||
Recruiting |
NCT05564026 -
Molecular Epidemiology of Pediatric Germ Cell Tumors
|