Lung CancerProWideNCT03608410
Intensified Follow-up of Lung Cancer Using Weekly Questionnaires Via the Internet
A study testing Weekly Internet based PRO questionnaires in people with Lung Cancer, run by Regional Hospital West Jutland at 1 site in Denmark.
Trial summary
This randomized controlled trial (RCT) 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Weekly Internet based PRO questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Sep 2018to 1 Nov 2022
- 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
- Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction treatment* for lung cancer and have no sign of progressive disease at first evaluation CT scan.
- Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.
- Diagnosis proven by cytology or histology
- Age ≥ 18 years
- Performance status (PS) ≤ 2 within 15 days before enrolment
- First evaluation CT scan performed within four weeks from enrolment
Show all 15Show fewer
- Patient with acess to internet, Mobile phone and E-boks (Danish digital secure mail system)
- Patient has given his/her written informed consent before any specific procedure from protocol
- Induction treatment includes:
- Standard doublet chemotherapy
- Immunotherapy
- Targeted therapy
- Palliative radiotherapy
- Local treatment of oligometastatic disease, including surgery and stereotactic radiotherapy
- Any combination of the above-mentioned treatment modalities Patients are eligible regardless of whether they at the time of inclusion continue maintenance treatment or not
Who cannot join
- Progressive disease at first evaluation scan
- 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
- Pregnant or breastfeeding women
- Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol committee.
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: ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial
This randomized controlled trial (RCT) 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 or worsening symptoms and the patient will be contacted by the treating clinicians.
Read the detailed description
This multicenter RCT study enrolls patients diagnosed with stage IV og incurable stage III lung cancer who has non-progressive disease at first evaluation scan. Patients in follow-up or maintenance therapy are eligible.
492 patients will be included in the study with 246 patients in each group.
Intervention In the experimental arm, patients will be asked to fill in a web-based Patient Reported Outcome (PRO) questionnaire every week. If one of the reported symptoms worsens and exceed a predefined threshold of severity, a notification is automatically sent to the hospital. A nurse will review til questionnaire and contact the patient for verification of symptoms. If progression of disease is suspected, a CT scan will be made. Otherwise, the nurse will schedule a visit at the clinic for physical examination and evaluation by a clinician. If progressive disease is not suspected, supportive care will be adjusted and the patient will continue follow up according to the usual schedule.
The interventions ends in case of progressive disease.
Evaluation Baseline CT-scan of thorax and upper abdomen is performed prior to initial treatment and an evaluation CT scan at the time of enrolment. CT scans will be repeated for assessing signs of progression due to standard follow-up procedures in both groups. If progressive disease is suspected based on symptom development, the following scan will be rescheduled to as soon as possible.
Quality of life (QoL) will be measured in both groups using EORTC (European Organisation for Research and Treatment of Cancer) QOL-C30 / LC13 and HADS (Hospital Anxiety And Depression Scale) quality of life questionnaires every 2 month during the study period.
Objectives The primary objective is to test if supplementary weekly PRO monitoring increases overall survival in a Danish Lung Cancer population
Monitoring Clinical decisions taken on the basis of PRO notifications will daily be registered in the software system by the clinicians. Patient responses to questionnaires and PRO-notification handling by the clinical staff will be monitored by Primary Investigator.
End points will be entered by local site investigators.
- Conditions
- Lung Cancer
- Being tested
- Weekly Internet based PRO questionnaires
- Keywords
- Patient reported outcomes, Internet, TelePRO
- 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 Internet based PRO questionnairesOther
If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital.
| Study group | Role | What they receive |
|---|---|---|
| PRO intervention | Experimental | Weekly PRO questionnaires Quality of life every 2 months Receives: Other: Weekly Internet based PRO questionnaires |
| Standard of care | No intervention | Quality of life every 2 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 2 years
Secondary outcomes (8)
ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression
(0-5) 0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction)
- - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work)
- - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours)
- - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours)
- - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
- - Death
Measured: 2 years
Progression free survival
Measured: 2 years
Type of treatment at time of progression
Number of patients who are candidates for 2nd line medical antineoplastic treatment
Measured: 2 years
Quality of life (QOL) measured by EuroQol EQ-5D-5L.
EQ-5D-5L measures individual generic health status using 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and each dimension has 5 levels depending on severity of symptoms (1 no problems, 5 extreme problems) and a VAS (visual analogue scale). The scores can then be converted into a single index number. The index value will be used for calculation of quality-adjusted life years (QALYs) for a health economic analysis of the intervention.
Measured: 2 years
Quality of life measured by EORTC QLQ C30/LC13.
The EORTC QLQ-C30 questionnaire consists of 30 questions with five functional scores (physical, role, cognitive, emotional and social); a global health status score three symptom scale score (fatigue, pain, nausea and vomiting); and six independent one-item scores describing additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation and diarrhea) and financial burden.
The EORTC QLQ-LC13 is a supplementary module to the C30 questionnaire and generates a multiple-item scale score of dyspnea and a number of single-item scores that assesses chest pain, arm / shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia and hemoptysis.
All scales and single-item scores can be linearly transformed to a score ranged from 0 to 100. A higher score of global health and functional subscriptions indicates better functioning.
Measured: 2 years
HADS score (Hospital Anxiety And Depression Scale)
The HADS (The hospital anxiety and depression scale) is a fourteen-item scale. Seven items relate to depression and seven to anxiety. The tool has been developed for detection of anxiety and depression in patients with physical health problems. All items are scored from 0-3 with a possible total score between 0 and 21 for anxiety and depression respectably.
A cut-off point of >7 for anxiety or depression is considered significant.
Measured: 2 years
Qualitative interviews
Qualitative interviews with members of the clinical staff and a group of patients in the intervention arm will be conducted during the study period. The purpose is to identify barriers, advantages and possible reasons for the outcomes of the study.
Measured: 2 years
Baseline questionnaires of non-participants
All patients who met the inclusion criteria but declined to participate in the trial will be asked to fill in a questionnaire. The questionnaire will include information on socioeconomics, reasons for non-participation and the same HRQoL questionnaires that are filled in by the participants in the trial (EORTC QLQ-C30/LC13, HADS, EQ-5D-5L).
The purpose is to identify baseline differences between participants and non-participants and thereby testing the PRO system for generalizability.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start18 Sep 2018
- Primary completion1 Sep 2021
- Study completion1 Nov 2022
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 CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process. A text message reminder is sent weekly for patients in the intervention group by the system. Quality of Life questionnaires will automatically be sent via a safe internet connection to participants in both groups every 2 months.
- Masking
- None (open label)
- Enrolment
- 494 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
- NCT03608410
- Sponsor's protocol ID
- ProWide
- Other IDs
- R184-A11805-17-S57, 2017-41-5251
- Acronym
- ProWide
- Status last verified
- Apr 2023
- First submitted
- 11 Jul 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Friis RB, Pappot H, Hjollund NH, McCulloch T, Holt MI, Persson GF, Wedervang K, Clausen MM, Wahlstrom S, Hansen KH, Rasmussen TR, Dalton SO, Jakobsen E, Linnet H, Skuladottir H; Danish Lung Cancer Group. Remote Symptom Monitoring of Patients With Advanced Lung Cancer (The ProWide Study): A Randomized Controlled Trial. JCO Oncol Pract. 2025 Jun;21(6):813-823. doi: 10.1200/OP-24-00562. Epub 2024 Dec 10.
PubMed 39657078
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProWide - Patient Reported Outcomes Used for Weekly Internet-based DEtection of Progressive Disease in Lung Cancer; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03608410
- Acronym / sponsor ID
- ProWide / ProWide
- Conditions
- Lung Cancer
- Keywords
- Patient reported outcomes, Internet, TelePRO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 494 participants (actual)
- Lead sponsor
- Regional Hospital West JutlandUniversity, hospital or other
- Collaborators
- Danish Cancer Society, Danish Lung Cancer Group
- Study start
- 18 Sep 2018 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 1 Aug 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.
This randomized controlled trial (RCT) 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 or worsening symptoms and the patient will be contacted by the treating clinicians.
Detailed description
This multicenter RCT study enrolls patients diagnosed with stage IV og incurable stage III lung cancer who has non-progressive disease at first evaluation scan. Patients in follow-up or maintenance therapy are eligible.
492 patients will be included in the study with 246 patients in each group.
Intervention In the experimental arm, patients will be asked to fill in a web-based Patient Reported Outcome (PRO) questionnaire every week. If one of the reported symptoms worsens and exceed a predefined threshold of severity, a notification is automatically sent to the hospital. A nurse will review til questionnaire and contact the patient for verification of symptoms. If progression of disease is suspected, a CT scan will be made. Otherwise, the nurse will schedule a visit at the clinic for physical examination and evaluation by a clinician. If progressive disease is not suspected, supportive care will be adjusted and the patient will continue follow up according to the usual schedule.
The interventions ends in case of progressive disease.
Evaluation Baseline CT-scan of thorax and upper abdomen is performed prior to initial treatment and an evaluation CT scan at the time of enrolment. CT scans will be repeated for assessing signs of progression due to standard follow-up procedures in both groups. If progressive disease is suspected based on symptom development, the following scan will be rescheduled to as soon as possible.
Quality of life (QoL) will be measured in both groups using EORTC (European Organisation for Research and Treatment of Cancer) QOL-C30 / LC13 and HADS (Hospital Anxiety And Depression Scale) quality of life questionnaires every 2 month during the study period.
Objectives The primary objective is to test if supplementary weekly PRO monitoring increases overall survival in a Danish Lung Cancer population
Monitoring Clinical decisions taken on the basis of PRO notifications will daily be registered in the software system by the clinicians. Patient responses to questionnaires and PRO-notification handling by the clinical staff will be monitored by Primary Investigator.
End points will be entered by local site investigators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The randomization will be done by the AmbuFlex-system (a generic on-line system for self-recorded patient reported outcomes) as a part of the inclusion process. A text message reminder is sent weekly for patients in the intervention group by the system. Quality of Life questionnaires will automatically be sent via a safe internet connection to participants in both groups every 2 months.
| Arm | Type | Receives |
|---|---|---|
| PRO intervention | Experimental | Other: Weekly Internet based PRO questionnairesWeekly PRO questionnaires Quality of life every 2 months |
| Standard of care | No intervention | –Quality of life every 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients with lung cancer (NSCLC and SCLC), who have received 1st line induction treatment* for lung cancer and have no sign of progressive disease at first evaluation CT scan.
- Patients diagnosed with stage III treated with palliative intention, and stage IV, regardless of treatment intention.
- Diagnosis proven by cytology or histology
- Age ≥ 18 years
- Performance status (PS) ≤ 2 within 15 days before enrolment
Key exclusion criteria (5 listed)
- Progressive disease at first evaluation scan
- 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
- Pregnant or breastfeeding women
- Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention. Participation in protocols related only to treatment will not preclude participation in the present study. Cases of doubt will be settled by the protocol committee.
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 Internet based PRO questionnairesIf core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital. | Other | PRO intervention |
Primary outcome
Overall survival
Time frame: 2 years
8 secondary outcomes
ECOG (Eastern Cooperative Oncology Group) Performance status at time of progression
Time frame: 2 years
Progression free survival
Time frame: 2 years
Type of treatment at time of progression
Time frame: 2 years
Quality of life (QOL) measured by EuroQol EQ-5D-5L.
Time frame: 2 years
Quality of life measured by EORTC QLQ C30/LC13.
Time frame: 2 years
HADS score (Hospital Anxiety And Depression Scale)
Time frame: 2 years
Qualitative interviews
Time frame: 2 years
Baseline questionnaires of non-participants
Time frame: 2 years
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 12 Apr 2023.
- Derived from this study: PubMed 39657078Friis RB, Pappot H, Hjollund NH, McCulloch T, Holt MI, Persson GF, Wedervang K, Clausen MM, Wahlstrom S, Hansen KH, Rasmussen TR, Dalton SO, Jakobsen E, Linnet H, Skuladottir H; Danish Lung Cancer Group. Remote Symptom Monitoring of Patients With Advanced Lung Cancer (The ProWide Study): A Randomized Controlled Trial. JCO Oncol Pract. 2025 Jun;21(6):813-823. doi: 10.1200/OP-24-00562. Epub 2024 Dec 10.
- Individual participant dataSharing planned: Undecided
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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 Internet based PRO questionnaires in people with Lung Cancer, 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 15 inclusion and 5 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 12 Apr 2023. 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?
Overall survival (time frame: 2 years). 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 NCT03608410, 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 12 Apr 2023.