Lung Cancer Stage IVNCT03529851
Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients
A study testing Weekly questionnaires in people with Lung Cancer Stage IV, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial summary
The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Stage IV
- What is being tested?
- Weekly questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 1 Aug 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks.
- Access to internet connection
- Performance status ≤ 2
- Patient has given his/her written informed consent
Who cannot join
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of oncology, Regional Hospital West Jutland
Herning, 7400
About this study
Official title: Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.
Read the detailed description
This pilot study will test if the use of AmbuFlex (a generic on-line system for self-recorded patient reported outcomes) is feasible for a following randomized trial (PRO-WIDE trial - Patient Reported Outcomes used for Weekly Internet-based DEtection of progressive disease in lung cancer; a randomized controlled trial). The RCT (randomized controlled trial) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming symptoms and the patient will be contacted by the clinicians.
In the pilot study, initial interviews with 7-10 patients will explore possible missing items and conceptual issues in the questionnaire. Based on the results an adjustment of the questionnaire will be considered.
Then the system including the alert trigger mechanism will be tested on 20 patients in medical antineoplastic treatment for three consecutive weeks. Acceptability, usability and relevance will be evaluated by a questionnaire at the end of the study period. Inclusion-rate, number of alerts per completed questionnaire and time usage of alert-management will be registered. For final evaluation, interviews with two nurses and two doctors will be made at the end of the study.
- Conditions
- Lung Cancer Stage IV
- Being tested
- Weekly questionnaires
- Keywords
- Patient reported outcomes, Symptom monitoring, Follow-up
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly questionnairesOther
In case of alarming symptoms reported in the questionnaire, an alert is automatically sent to the hospital. The clinicians will contact the patient, confirm the symptoms and intervene according to standard practice.
| Study group | Role | What they receive |
|---|---|---|
| PRO intervention | Experimental | Patients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period. Receives: Other: Weekly questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Techincal feasibility, acceptability and usability of the PRO system for patients
Measured by an evaluation questionnaire at the end of the pilot study categorized according to the specified topics with 5 response items for each question. All responses will be presented in a comprehensive chart.
Measured: 3 weeks
Inclusion rate
Number of included patients per screened patients Reasons for non-participation
Measured: 3 weeks
Time usage per day on approval and handling alerts
Minutes spent per alert Minutes spent per telephone call
Measured: 3 weeks
Barriers for implementation of the PRO system according to the clinical staff
Identified through interviews with 2 nurses and 2 MDs after the study period
Measured: 3 weeks
Exploration of possible missing items and conceptual issues in the questionnaire.
Identified through interviews with 7-10 patients prior to the pilot study.
Measured: 3 weeks
Alert-rate
Number of alerts sent to the hospital per questionnaires completed
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 May 2018
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer Stage IVStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regional Hospital West Jutland
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society, Danish Lung Cancer Group
- Responsible party
- Principal investigator, Rasmus Blechingberg Friis, Regional Hospital West Jutland
- Investigators
- Rasmus Friis, MD, Principal investigator, Department of Oncology, Regional Hospital West Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529851
- Sponsor's protocol ID
- RHWJutland
- Status last verified
- Aug 2018
- First submitted
- 24 Apr 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friis RB, Hjollund NH, Mejdahl CT, Pappot H, Skuladottir H. Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study. BMJ Open. 2020 Jun 17;10(6):e035673. doi: 10.1136/bmjopen-2019-035673.
PubMed 32554725
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Web-based Patient Reported Outcome Symptom Monitoring Application in Danish Lung Cancer Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT03529851
- Acronym / sponsor ID
- RHWJutland
- Conditions
- Lung Cancer Stage IV
- Keywords
- Patient reported outcomes, Symptom monitoring, Follow-up
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Danish Lung Cancer Group
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 May 2018 (actual)
- 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.
The trial is a pilot study prior to a following phase III trial and is designed to test the feasibility, acceptability and technical usability of supplementary web-based follow-up in lung cancer via a patient-reported outcome application.
Detailed description
This pilot study will test if the use of AmbuFlex (a generic on-line system for self-recorded patient reported outcomes) is feasible for a following randomized trial (PRO-WIDE trial - Patient Reported Outcomes used for Weekly Internet-based DEtection of progressive disease in lung cancer; a randomized controlled trial). The RCT (randomized controlled trial) will test if weekly supplementary internet-based self-monitoring of 12 core symptoms can increase survival in Danish lung cancer patients during follow-up or maintenance treatment. A threshold mechanism will automatically send an alert to the hospital in case of alarming symptoms and the patient will be contacted by the clinicians.
In the pilot study, initial interviews with 7-10 patients will explore possible missing items and conceptual issues in the questionnaire. Based on the results an adjustment of the questionnaire will be considered.
Then the system including the alert trigger mechanism will be tested on 20 patients in medical antineoplastic treatment for three consecutive weeks. Acceptability, usability and relevance will be evaluated by a questionnaire at the end of the study period. Inclusion-rate, number of alerts per completed questionnaire and time usage of alert-management will be registered. For final evaluation, interviews with two nurses and two doctors will be made at the end of the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility pilot study
| Arm | Type | Receives |
|---|---|---|
| PRO intervention | Experimental | Other: Weekly questionnairesPatients included will weekly fill in a 12 item questionaire via the internet during the 3 week study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage IV lung cancer in palliative treatment with 3 weeks treatment intervals and next planned attendance at the hospital after 3 weeks.
- Access to internet connection
- Performance status ≤ 2
- Patient has given his/her written informed consent
Key exclusion criteria (2 listed)
- Persons deprived of liberty or under guardianship or curators
- Dementia, mental alteration or psychiatric disease that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial.
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 |
|---|---|---|
| Weekly questionnairesIn case of alarming symptoms reported in the questionnaire, an alert is automatically sent to the hospital. The clinicians will contact the patient, confirm the symptoms and intervene according to standard practice. | Other | PRO intervention |
Primary outcome
Techincal feasibility, acceptability and usability of the PRO system for patients
Time frame: 3 weeks
Measured by an evaluation questionnaire at the end of the pilot study categorized according to the specified topics with 5 response items for each question. All responses will be presented in a comprehensive chart.
Inclusion rate
Time frame: 3 weeks
Number of included patients per screened patients Reasons for non-participation
Time usage per day on approval and handling alerts
Time frame: 3 weeks
Minutes spent per alert Minutes spent per telephone call
Barriers for implementation of the PRO system according to the clinical staff
Time frame: 3 weeks
Identified through interviews with 2 nurses and 2 MDs after the study period
Exploration of possible missing items and conceptual issues in the questionnaire.
Time frame: 3 weeks
Identified through interviews with 7-10 patients prior to the pilot study.
Alert-rate
Time frame: 3 weeks
Number of alerts sent to the hospital per questionnaires completed
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 29 Aug 2018.
- Derived from this study: PubMed 32554725Friis RB, Hjollund NH, Mejdahl CT, Pappot H, Skuladottir H. Electronic symptom monitoring in patients with metastatic lung cancer: a feasibility study. BMJ Open. 2020 Jun 17;10(6):e035673. doi: 10.1136/bmjopen-2019-035673.
- Individual participant dataSharing planned: No
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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.
Rasmus Friis, MD principal investigator
Department of Oncology, Regional Hospital West Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly questionnaires in people with Lung Cancer Stage IV, run by Regional Hospital West Jutland at 1 site 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 4 inclusion and 2 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Techincal feasibility, acceptability and usability of the PRO system for patients (time frame: 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03529851, which also lists 1 linked publication.
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 29 Aug 2018.