Patiënt gerapporteerde symptoom monitoring door middel van een web applicatie bij longkankerpatiënte

Conditions: ung cancer

Registration Number: NL-OMON29336

Lead Sponsor: Amsterdam UMC, location VUmc, Antoni van Leeuwenhoek hospital, Integraal Kankercentrum Nederland (IKNL)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 584

Inclusion Criteria

Cytological or histologically proven or radiological suspect small or non-small cell lung cancer patients.
-Patients that are starting (new) treatment with radiotherapy, surgery, chemotherapy, immunotherapy or targeted therapy, or a combination.
-Age 18 years or older.
-ECOG Performance Status classification should be 0, 1 or 2.
-Access to internet.

Exclusion Criteria

-Participating in a treatment study, when a structured symptom reporting is already part of such a study.
-Life expectancy at moment of inclusion is shorter than 15 weeks.
-The patient’s treatment and follow up does not remain in an affiliated hospital.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary end-point of this study is the difference in QoL between baseline and 15 weeks, 6 months, and 12 months post start of treatment (EORTC QLQ C30) between the intervention groups (PRO symptom monitoring) and standard care group. An effect size (ES) of 0.4 is considered a clinically relevant difference between the PRO symptom monitoring intervention and standard care. An ES of less than 0.2 between the active and a reactive approach is considered as a non-inferior difference.

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures include: <br>•1-year PFS <br>•1-year OS <br>•1-year recurrence rate <br>•Symptom incidence and severity over time (PRO-CTCAE for the intervention group only and EORTC QLQ lung module (LC-13) for both groups)<br>•Medication adherence (OACA) (Medication Adherence Report Scale (MARS-5)) and Believes about Medicine Questionnaire (BMQ)<br>•Cost-effectiveness (Euroqol-5 Dimensions with 5 levels (EQ-5D-5L) and clinical healthcare costs data)<br>•Implementation fidelity (intervention group only; quantitative and qualitative patient and HCP reported).