Head and Neck Cancer PatientsNCT01803061
Use of Computer-based Patient-reported Data to Assess Long Term and Late Effects of Head and Neck Cancer at the Point-of-care
A study testing WebCan in people with Head and Neck Cancer Patients and Late Effects, run by Danish Cancer Society at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head and Neck Cancer Patients, Late Effects
- What is being tested?
- WebCan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2010to Jul 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with recurrence of their cancers and patients still in treatment.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Danish Cancer Society Research Center, Unit of Suvivorship
Copenhagen, Ø, DK-2100
Herlev Hospital
Herlev, 2730
About this study
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.
Read more
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.
- Conditions
- Head and Neck Cancer Patients, Late Effects
- Being tested
- WebCan
- Keywords
- Head and neck cancer, Quality of life, Symptom-burden, Late effects
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebCanBehavioural
Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer
| Study group | Role | What they receive |
|---|---|---|
| WebCan | Experimental | Provides computerized PRO to the treating physician at the point of care Receives: Behavioral: WebCan |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of late effects
Measured: baseline, 6 and 12 months follow-up
Secondary outcomes (1)
Quality of life
Quality of life at baseline and 12 months follow-up
Measured: baseline, 6 and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startSep 2010
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Cancer Society
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Sygekassernes Helsefond
- Responsible party
- Principal investigator, Trille Kjær, Danish Cancer Society
- Investigators
- Christoffer Johansen, Professor, Study director, Danish Cancer Society Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803061
- Sponsor's protocol ID
- WebCan
- Status last verified
- Mar 2015
- First submitted
- 21 Feb 2013
- Last updated
- 6 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01803061
- Acronym / sponsor ID
- WebCan
- Conditions
- Head and Neck Cancer Patients, Late Effects
- Keywords
- Head and neck cancer, Quality of life, Symptom-burden, Late effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Danish Cancer SocietyUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Sygekassernes Helsefond
- Study start
- Sep 2010
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WebCan | Experimental | Behavioral: WebCanProvides computerized PRO to the treating physician at the point of care |
| Usual care | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with recurrence of their cancers and patients still in treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WebCanProvide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer | Behavioural | WebCan |
Primary outcome
Prevalence of late effects
Time frame: baseline, 6 and 12 months follow-up
1 secondary outcome
Quality of life
Time frame: baseline, 6 and 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoffer Johansen, Professor study director
Danish Cancer Society Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WebCan in people with Head and Neck Cancer Patients and Late Effects, run by Danish Cancer Society at 2 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 1 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: finished, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of late effects (time frame: baseline, 6 and 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015; AzTrials last refreshed its copy on 1 Nov 2026.