No registrations found.
ID
Source
Brief title
Health condition
Cancer, specifically a brain tumor or lung cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is whether or not documentation of (changes in) patient personal goals is present in case of documented medical decision-making in the medical file.
Secondary outcome
The secondary endpoints are dialogue on patient personal goals in outpatient consultations and patient experienced level of goal concordant decision-making. Other endpoints include potential spill over of the briefing, quality of life, depression and anxiety, emergency visits and hospitalisations, likeliness to recommend Goings-On, frequency of use of Goings-On, consultation time and patients and clinicians thoughts in getting goal-concordant care .
Background summary
Patient personal goals are individual and change over time. Yet doctors rarely document and ask patients about their goals. When doctors are not aware of goals, care (i.e. diagnostics, treatments, symptom management) cannot be aligned with what matters most to patients, besides just living longer. Primary objective of this project is to assess if the Goings-On app is effective in increasing awareness among caregivers of patients’ personal goals, measured by increased documentation of (changes in) patient personal goals in the medical file. Secondary objectives are to assess whether patient personal goals are more often discussed in outpatient consultations and to what extent patients experience goal concordant decision-making.
Study objective
The intervention is hypothesized to increase patient goal documentation, patient goal dialogue and patient experienced level of goal-concordant decision-making, compared to the control group.
Study design
Quality of Life and Anxiety and Depression assessments are planned at baseline, i.e. prior to getting access to the Goings-On app, and after 3 months, i.e. after the end of the study. The secondary endpoints and consultation time are measured during and after each consultation. All other measures are established after the end of the study, 3 months after baseline.
Intervention
Medical specialists and nurse specialists who are likely to have consultations with study patients, whether in the intervention or control group, during the three months of research, receive a 1-hour briefing. Patients in the control group receive usual care. Patients in the intervention group get access to the Goings-On app and get told by the research nurse that medical specialists and nurse specialists really want to know what matters most to them, to enable treatments that not only match the disease, but also the person. The Goings-On app enables patients to log their personal goal attainment and symptom burden within a minute on a daily basis.
Both the briefing and giving patients explicitly permission to participate are evidence informed. Goings-On has been tested for usability via think aloud testing with patients of the Netherlands Cancer Institute and people who have trouble reading, the latter in cooperation with the Dutch Centre of Expertise on Health Disparities Pharos.
Inclusion criteria
In order to be eligible to participate in this study a participant must meet all of the following criteria:
1) Advanced (grade III/IV) brain tumor or lung cancer;
2) Age 18 years or older;
3) Own an iPhone 5s or newer;
4) Have at least one clinical oncology appointment within the three months of the research;
5) Fluent in Dutch.
Exclusion criteria
1) Being a participant in another clinical study (to avoid potential contamination of the findings in the other study);
2) Unable physically and/or mentally to use the app on a daily basis and/or participate in an interview and/or fill out a digital questionnaire.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8236 |
| Other | METC Leiden Den Haag Delft : N19.060 (not subject to the WMO) |