None listed
Conditions
Brief summary
The purpose of this study is to see if symptom monitoring can improve quality of life in people with upper gastrointestinal cancer (stomach, pancreas and oesophagus cancer). Who is it for? You may be eligible for this study if you have been diagnosed with pancreatic, oesophageal or gastric cancer, and are participating in the Upper Gastrointestinal Cancer Registry. Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. One group will participate in the PROpatient intervention, where they complete a symptom monitoring tool (an electronic questionnaire) using a phone, tablet or computer approximately every two weeks (or a often as required). Their answers to the questions will be used to send them self-management guides or to refer them to supportive health services if required. The other group (control group) will not use the PROpatient intervention. Both groups will complete additional questionnaires about their quality of life, and patient information needs, after recruitment, at 3 months, 6 months and 12 months. It is hoped this research will show that the collection and integration of patient-reported symptoms into clinical practice will improve communication with health care professionals and improve cancer management.
Interventions
The PROpatient intervention involves the frequent monitoring of disease-specific symptoms. Data is collected from the participant’s personal smart phone, tablet or computer, at any time, and as frequently as required. The total duration of the intervention is up to 12 months.
The electronic 'symptom monitoring tool' is a questionnaire, developed by a team clinicians and expert researchers in the field of patient-reported outcomes (PROs). It consists of a series of symptom-based questions, with
The PROpatient intervention involves the frequent monitoring of disease-specific symptoms. Data is collected from the participant’s personal smart phone, tablet or computer, at any time, and as frequently as required. The total duration of the intervention is up to 12 months. The electronic 'symptom monitoring tool' is a questionnaire, developed by a team clinicians and expert researchers in the field of patient-reported outcomes (PROs). It consists of a series of symptom-based questions, with a 0-10 scale, taking a maximum of 20 minutes to complete. Participants will be prompted to complete the symptom monitoring tool by SMS or email every two weeks, if no responses have been received during the previous two week period. The IT platform used to collect the data will integrate it into a dashboard with participants reporting severe or worsening symptoms (according to an escalation policy) being flagged. Project-based cancer care coordinators will have access to the dashboard, triage and contact flagged participants within 1-2 business days, and, if relevant, refer them to the appropriate site-specific health services and/or professionals (according to the site-specific decision support guide). Evidence-based self-management guides and resources will be provided in real-time to participants reporting mild or moderate symptoms (according to an escalation policy) upon each completion of the symptom monitoring tool. Patient-level reports will be provided to treating clinicians in real-time, via an email link through the IT platform, highlighting severe and/or worsening symptoms. Participants in the intervention arm will also complete the EORTC QLQ C30 and PINQ questionnaires at baseline, 3 months, 6 months and 12 months post-randomisation.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients participating in the Upper Gastrointestinal Cancer Registry, who are newly diagnosed (up to 3 months post-diagnosis) with pancreatic, oesophageal and gastric cancer that are diagnosed, managed or treated at one of the participating trial sites.
Exclusion criteria
Participants who do not meet the inclusion criteria, require an interpreter (non-English speaking), or without the capacity to give informed consent (suffering from dementia, delirium or confusion), will be excluded from the study.
Outcome results
None listed