Study of PRO in Patients With Advanced Pancreatic or Biliary Tract Cancer (BetterEveryDay)

ConditionsPancreatic Cancer Lung Cancer, Nonsmall Cell

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorInna Chen, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

Supportive application with integrated weekly PRO
Other intervention
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.

Treatment groups

274 Participants

are divided into 2 treatment groups

Group A: Intervention ArmExperimental treatment 1 intervention

Group B: Standard ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

Feasibility (Part A)

\- Proportion of enrolled patients responding to at least two consecutive questionnaires by 12 weeks

Time frame

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.

Time frame

6 months

Secondary outcomes

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

Time frame

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.

Time frame

6 months

Overall survival

\- 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)

\- Adjusted mean in score from the modified HCCQ at 12 and 24 weeks.

Time frame

6 months

Other outcomes

Out-of-patient care and resource utilization

\- Time to first ER visit and/or hospitalization

Time frame

6 months

Out-of-patient care and resource utilization

\- Rates of hospital admissions

Time frame

6 months

Out-of-patient care and resource utilization

\- Mean length of hospital stay

Time frame

6 months

Out-of-patient care and resource utilization

\- Number of additional/unplanned nursing calls

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Inna Chen, MD

Lead sponsor

Herlev Hospital

Sponsor institution

Roche Pharma AG

Collaborator

Source ClinicalTrials.gov

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