Pancreatic CancerBetterEveryDayNCT04611867
Study of PRO in Patients With Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)
A study testing Supportive application with integrated weekly PRO in people with Pancreatic Cancer and Lung Cancer, Nonsmall Cell, run by Inna Chen, MD at 1 site in Denmark.
Trial summary
Pancreatic and biliary tract cancer are ones of the leading causes of cancer-related deaths. During the course of illness, these patients often experience marked physical suffering, psychological distress and frequent unplanned resource-demanding hospitalized care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Lung Cancer, Nonsmall Cell
- What is being tested?
- Supportive application with integrated weekly PRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Aug 2021to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult (aged 18 and over)
- Confirmed by cytology or histology advanced lung (NSCLC) or pancreatic cancer
- Written informed consent before any study procedures
- Planning to receive 1st line systemic anticancer therapy within ≤2 weeks
- Performance status: ECOG 0-2
- Access to the internet
- Ability to read and respond to questions or able to complete questions with minimal assistance required from an interpreter or family member
Who cannot join
- No mobile device
- Exhibiting signs of overt psychopathology or cognitive dysfunction
- Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
- 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 responsible.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Herlev & Gentofte University Hospital, Denmark
Herlev, 2730
Inna Chen, MD, +45 38682898, Inna.Chen@regionh.dk
Dorte Nielsen, MD DMSc, +45 38682344, Dorte.Nielsen.01@regionh.dk
About this study
Official title: Study of Supportive Application With Integrated Patient-Reported Outcomes in Patients With Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)
Pancreatic and biliary tract cancer are ones of the leading causes of cancer-related deaths. During the course of illness, these patients often experience marked physical suffering, psychological distress and frequent unplanned resource-demanding hospitalized care. Patients with pancreatic and lung cancer have highest rates of unplanned hospitalizations. Investigator initiated prospective "Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)" is to be initiated based on the great need for optimizing treatment care, reducing hospitalizations and improving outcomes.
Read the detailed description
The trial is designed as an investigator initiated prospective study of patients with advanced pancreatic or biliary tract cancer initiating systemic treatment to determine the feasibility and efficacy of supportive application with integrated weekly Patient-Reported Outcomes (PRO) on unplanned hospitalization, Quality of Life (QoL), survival, satisfaction with oncologist communication, and resource utilization.
This study will consist of Part A (Feasibility), as well as a possible Part B (Randomized controlled trial, RCT).
Initially, 30 patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy will be enrolled in the Part A to assess the feasibility of the supportive application with integrated weekly PRO. Patients included in feasibility Part A will be instructed in self-reporting via web-based supportive application with integrated weekly PRO.
In case of successfully completed Part A, the randomized Part B will be activated to determine the efficacy of the supportive application with integrated weekly PRO on unplanned hospitalization, QoL, survival, satisfaction and resource utilization for patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy. Format of that Part B will be adjusted if indicated based on the feasibility responses seen in the 30 patients in Part A. Patients will be randomized in Part B with a 1:1 ratio in a stratified manner according to cancer type (biliary tract cancer versus pancreatic cancer). If initiated, the data from Part B: RCT will be analyzed separately and will not be pooled with Part A for the purpose of statistical analysis.
Over the course of the study patients in both arms will be asked to complete questionnaires about QoL at baseline and week 12 and 24. Additionally, patients in both arms are asked to complete the modified Health Care Climate Questionnaire (HCCQ) at week 12 and 24.
- Conditions
- Pancreatic Cancer, Lung Cancer, Nonsmall Cell
- Being tested
- Supportive application with integrated weekly PRO
- Medical subject headings
- Pancreatic Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive application with integrated weekly PROOther
Patients will fill in a web-based application PRO-CTCAE with integrated preparation questionnaire every week. If their weekly reported symptoms exceed a predefined threshold of severity, this results in a notification on the staff application interface and a nurse will contact a patient for verification of symptoms. Nurse will review patient recent treatment and PRO reports and advise patient according to the local practice for symptom management and reinforce reporting. Nurse will consult with or refers to (if possible) treating physician if patient will require medical intervention and/or physician assistance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | The intervention will be comprised of providing patients with supportive application with integrated PRO consisting of:
* Weekly self-reporting of PRO-CTCAE with integrated preparation questionnaire available for staff
* Daily monitoring of self-reporting by study staff
* Intervention if required based on self-reporting
* Reports to oncologists (at consultation)
* Information module about treatment, side effects and contact information Receives: Other: Supportive application with integrated weekly PRO |
| Standard Arm | No intervention | Standard care for patients will be included in no-intervention arm will consist of the standard procedures at Herlev Hospital, Department of Oncology for monitoring and documenting symptoms, which will be typical of oncology practice. Symptoms will be discussed and documented in the medical record during clinical encounters between patients and their oncologists. Patients will be encouraged to initiate telephone contact between visits for concerning symptoms, i.e. "call early and often". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility (Part A)
- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks
Measured: 3 months
Hospitalization (Part B)
- Hospitalization with any unplanned admission to the hospital and/or emergency department within the 24 weeks beginning from the day of randomization.
Measured: 6 months
Secondary outcomes (4)
EORTC QLQ-C30 global health status/QoL scale
- Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 and 24 weeks
Measured: 6 months
EORTC QLQ-C30 functional scales and symptom scales/items
- Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.
Measured: 6 months
Overall survival
- Overall survival
Measured: 1 year
Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ)
- Adjusted mean in score from the modified HCCQ at 12 and 24 weeks.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start17 Aug 2021
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
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 Pancreatic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inna Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor-investigator, Inna Chen, MD, Herlev Hospital
- Investigators
- Inna M Chen, MD, Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611867
- Sponsor's protocol ID
- AA2058
- Acronym
- BetterEveryDay
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2020
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mikkelsen MK, Rolin L, Theile S, Markman MJN, Hald C, Chen IM. What matters most early in the cancer trajectory: patient concerns and priorities in pancreatic and lung cancer (BetterEveryDay trial). Eur J Oncol Nurs. 2026 Aug 15;84:103301. doi: 10.1016/j.ejon.2026.103301. Online ahead of print.
PubMed 42617508
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Supportive Application With Integrated Patient-Reported Outcomes in Patients With Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)
- ClinicalTrials.gov ID
- NCT04611867
- Acronym / sponsor ID
- BetterEveryDay / AA2058
- Conditions
- Pancreatic Cancer, Lung Cancer, Nonsmall Cell
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Inna Chen, MDUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 2 Nov 2020 (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.
Pancreatic and biliary tract cancer are ones of the leading causes of cancer-related deaths. During the course of illness, these patients often experience marked physical suffering, psychological distress and frequent unplanned resource-demanding hospitalized care. Patients with pancreatic and lung cancer have highest rates of unplanned hospitalizations. Investigator initiated prospective "Study of Supportive Application with Integrated Patient-Reported Outcomes in Patients with Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)" is to be initiated based on the great need for optimizing treatment care, reducing hospitalizations and improving outcomes.
Detailed description
The trial is designed as an investigator initiated prospective study of patients with advanced pancreatic or biliary tract cancer initiating systemic treatment to determine the feasibility and efficacy of supportive application with integrated weekly Patient-Reported Outcomes (PRO) on unplanned hospitalization, Quality of Life (QoL), survival, satisfaction with oncologist communication, and resource utilization.
This study will consist of Part A (Feasibility), as well as a possible Part B (Randomized controlled trial, RCT).
Initially, 30 patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy will be enrolled in the Part A to assess the feasibility of the supportive application with integrated weekly PRO. Patients included in feasibility Part A will be instructed in self-reporting via web-based supportive application with integrated weekly PRO.
In case of successfully completed Part A, the randomized Part B will be activated to determine the efficacy of the supportive application with integrated weekly PRO on unplanned hospitalization, QoL, survival, satisfaction and resource utilization for patients with advanced lung (NSCLC) and pancreatic cancer initiating systemic therapy. Format of that Part B will be adjusted if indicated based on the feasibility responses seen in the 30 patients in Part A. Patients will be randomized in Part B with a 1:1 ratio in a stratified manner according to cancer type (biliary tract cancer versus pancreatic cancer). If initiated, the data from Part B: RCT will be analyzed separately and will not be pooled with Part A for the purpose of statistical analysis.
Over the course of the study patients in both arms will be asked to complete questionnaires about QoL at baseline and week 12 and 24. Additionally, patients in both arms are asked to complete the modified Health Care Climate Questionnaire (HCCQ) at week 12 and 24.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Supportive application with integrated weekly PROThe intervention will be comprised of providing patients with supportive application with integrated PRO consisting of: * Weekly self-reporting of PRO-CTCAE with integrated preparation questionnaire available for staff * Daily monitoring of self-reporting by study staff * Intervention if required based on self-reporting * Reports to oncologists (at consultation) * Information module about treatment, side effects and contact information |
| Standard Arm | No intervention | –Standard care for patients will be included in no-intervention arm will consist of the standard procedures at Herlev Hospital, Department of Oncology for monitoring and documenting symptoms, which will be typical of oncology practice. Symptoms will be discussed and documented in the medical record during clinical encounters between patients and their oncologists. Patients will be encouraged to initiate telephone contact between visits for concerning symptoms, i.e. "call early and often". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (aged 18 and over)
- Confirmed by cytology or histology advanced lung (NSCLC) or pancreatic cancer
- Written informed consent before any study procedures
- Planning to receive 1st line systemic anticancer therapy within ≤2 weeks
- Performance status: ECOG 0-2
Key exclusion criteria (4 listed)
- No mobile device
- Exhibiting signs of overt psychopathology or cognitive dysfunction
- Any medical condition that the Investigator considers significant to compromise the safety of the patient or that impairs the interpretation of study assessments
- 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 responsible.
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 |
|---|---|---|
| Supportive application with integrated weekly PROPatients will fill in a web-based application PRO-CTCAE with integrated preparation questionnaire every week. If their weekly reported symptoms exceed a predefined threshold of severity, this results in a notification on the staff application interface and a nurse will contact a patient for verification of symptoms. Nurse will review patient recent treatment and PRO reports and advise patient according to the local practice for symptom management and reinforce reporting. Nurse will consult with or refers to (if possible) treating physician if patient will require medical intervention and/or physician assistance. | Other | Intervention Arm |
Primary outcome
Feasibility (Part A)
Time frame: 3 months
- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks
Hospitalization (Part B)
Time frame: 6 months
- Hospitalization with any unplanned admission to the hospital and/or emergency department within the 24 weeks beginning from the day of randomization.
4 secondary outcomes
EORTC QLQ-C30 global health status/QoL scale
Time frame: 6 months
EORTC QLQ-C30 functional scales and symptom scales/items
Time frame: 6 months
Overall survival
Time frame: 1 year
Satisfaction with oncologist communication at 12 and 24 weeks as measured by the modified Health Care Climate Questionnaire (HCCQ)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 42617508Mikkelsen MK, Rolin L, Theile S, Markman MJN, Hald C, Chen IM. What matters most early in the cancer trajectory: patient concerns and priorities in pancreatic and lung cancer (BetterEveryDay trial). Eur J Oncol Nurs. 2026 Aug 15;84:103301. doi: 10.1016/j.ejon.2026.103301. Online ahead of print.
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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.
Inna M Chen, MD principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive application with integrated weekly PRO in people with Pancreatic Cancer and Lung Cancer, Nonsmall Cell, run by Inna Chen, MD 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inna M Chen, MD (+45 38682898, Inna.Chen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (Part A) (time frame: 3 months). The study lists 2 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 NCT04611867, 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 2 Sep 2026.