- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611867
Study of PRO in Patients With Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay) (BetterEveryDay)
Study of Supportive Application With Integrated Patient-Reported Outcomes in Patients With Advanced Pancreatic or BiliaryTract Cancer (BetterEveryDay)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Inna M Chen, MD
- Phone Number: +45 38682898
- Email: Inna.Chen@regionh.dk
Study Locations
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-
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Herlev, Denmark, 2730
- Recruiting
- Herlev & Gentofte University Hospital, Denmark
-
Contact:
- Dorte Nielsen, MD DMSc
- Phone Number: +45 38682344
- Email: Dorte.Nielsen.01@regionh.dk
-
Contact:
- Inna Chen, MD
- Phone Number: +45 38682898
- Email: Inna.Chen@regionh.dk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Arm
The intervention will be comprised of providing patients with supportive application with integrated PRO consisting of:
|
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.
|
No Intervention: Standard Arm
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility (Part A)
Time Frame: 3 months
|
- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks
|
3 months
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EORTC QLQ-C30 global health status/QoL scale
Time Frame: 6 months
|
- Adjusted mean change from baseline in global health status/QoL score from the EORTC QLQ-C30 questionnaire at 12 and 24 weeks
|
6 months
|
EORTC QLQ-C30 functional scales and symptom scales/items
Time Frame: 6 months
|
- Adjusted mean change from baseline in functional and symptom scales from the EORTC QLQ-C30 questionnaire at 6, 12 and 24 weeks.
|
6 months
|
Overall survival
Time Frame: 1 year
|
- Overall survival
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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
|
- Adjusted mean in score from the modified HCCQ at 12 and 24 weeks.
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Out-of-patient care and resource utilization
Time Frame: 6 months
|
- Time to first ER visit and/or hospitalization
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6 months
|
Out-of-patient care and resource utilization
Time Frame: 6 months
|
- Rates of hospital admissions
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6 months
|
Out-of-patient care and resource utilization
Time Frame: 6 months
|
- Mean length of hospital stay
|
6 months
|
Out-of-patient care and resource utilization
Time Frame: 6 months
|
- Number of additional/unplanned nursing calls
|
6 months
|
Out-of-patient care and resource utilization
Time Frame: 6 months
|
- Number of additional/unplanned out-patient care visits
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6 months
|
Tolerability of systemic therapy
Time Frame: 6 months
|
- Time receiving active cancer treatment
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Inna M Chen, MD, Herlev and Gentofte Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA2058
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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