Lung cancer Lung carcinoma
Conditions
Interventions
The intervention of this study consists of a web-based application that can be
used via a mobile phone (or laptop/ computer/ tablet) to monitor symptoms and
medication adherence. The symptoms of pat
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Cytological or histologically proven or radiological suspect small or non-small cell lung cancer patients that are starting treatment with radiotherapy, surgery, chemotherapy, immunotherapy or targeted therapy, or a combination. Other inclusion criteria are 18 years and older, ECOG Performance Status classification should be 0,1 or 2 and access to internet.
Exclusion criteria
Exclusion criteria: Patients who are participants of a treatment study or when their life expectancy at moment of inclusion is shorter than 15 weeks. The patient*s treatment and follow up will have to remain in an affiliated hospital
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to measure the difference in QoL (EORTC QLQ C30 score), 15 weeks after the start of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary aims are studying the effect of PRO symptom monitoring, active versus reactive, and intervention compared to standard care through the following outcomes - Symptoms will be measured post treatment, at 15 weeks, 6 months and 12 months, by using the EORTC QLQ lung module (LC-13). The LC-13 measures specific treatment related symptoms of lung cancer. - Recurrence will be measured at 15 weeks, 6 and retrospectively at 12 months post treatment by posing a single question to the HCPs querying occurrence and/or time of recurrence. OS data will be retrieved from the Dutch Cancer Registry (NKR) and will be defined as time from start of treatment until death. - Medication adherence will be assessed using the Medication Adherence Report Scale (MARS-5) at 15 weeks, 6, and 12 months. - Cost effectiveness will be analyzed by determining the incremental cost effectiveness and cost-utility ratio of each strategy. An externally validated model on cost-effectiveness using observational data will be used to compare the two PRO symptom monitoring approaches. Observational data will be obtained by a link with the NKR, Dutch Hospital Data (DHD) and Vectiz as well as the Euroqol-5 Dimensions with 5 levels questionnaire (EQ-5D). - The implementation fidelity will be analysed using a mixed methods design with quantitative and qualitative data to investigate the implementation process of the PRO symptom monitoring app. | — |
Countries
Netherlands
Outcome results
None listed