The primary aim of the study is to compare the effect of PRO symptom monitoring with standard care on QoL both during and up to 1 year after treatment. Secondary aims are studying the effect of PRO symptom monitoring compared to standard care on the…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is to measure the difference in QoL (EORTC QLQ C30 score),
15 weeks after the start of the treatment.
Secondary outcome
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.
Background summary
Lung cancer and its treatment provide a wide range of symptoms and side effects
in the patient such as dyspnea, cough and pain. These symptoms have a
significant impact on the quality of life of patients. Recently, several trials
have shown that the use of patient reported outcomes (PROs) for monitoring
these complaints not only improves symptom management, but also significantly
improves quality of life (QOL) and overall survival (OS). Potential underlying
mechanisms for these results are the earlier response in case of severe
symptoms, such as the more frequent prescription of supportive medication, dose
adjustments or referrals.
Study objective
The primary aim of the study is to compare the effect of PRO symptom monitoring
with standard care on QoL both during and up to 1 year after treatment.
Secondary aims are studying the effect of PRO symptom monitoring compared to
standard care on the incidence and severity of PRO symptoms, medication
adherence, progression, OS and cost effectiveness.
Additionally, we will compare an active follow up approach with a reactive
approach of PRO symptom monitoring, study the influence of monitoring
medication adherence of patients using oral anticancer agents (OACAs) compared
to standard care and study the implementation fidelity of implementing the PRO
symptom monitoring tool within the clinical practice setting.
Study design
The study uses a stepped wedge design. This means that every hospital starts
with a control period in which only control patients are included. Over a
period of 16 months, the hospitals will consecutively switch to the
intervention. Participating hospitals are randomized between either active or
reactive monitoring of symptoms.
Intervention
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 patients and will be queried through the
app by using a subset of questions that are clinically relevant for lung cancer
patients. For patients using OACAs the app also monitors medication adherence
and gives advice
Adherence of the web-based application use is encouraged by weekly reminders
through a push notification. A scoring algorithm will be used to assess the
severity of the reported symptoms and medication adherence.
The active intervention group
The alert will be sent by (secured) e-mails to the health care practitioners
(HCPs). HCPs are then expected to contact the patient (during office hours)
within 24 hours on working days to give a tailored advice and to explore
whether a visit to the hospital, or other interventions are required. Patients
can, however, call or visit the hospital 24 hours a day and 7 days per week in
case of an emergency.
The reactive intervention group
With the reactive approach, the automatic alert provides patients with a push
notification containing the advice to contact the hospital themselves within 24
hours. Patients can call or visit the hospital 24 hours a day and 7 days per
week in case of an emergency. The PRO-data will be accessible during a HCPs
consultation.
All patients will also receive the written standard of care patient information
that is provided for the specific treatment they receive e.g. immediately
contact the HCP in case of fever. In this information specific instructions are
provided when to contact the treating HCPs (e.g. in case of fever).
Study burden and risks
The burden on patients consists of the extra time they have to spend on
completing the weekly symptoms list, and the 4 measurement moments (baseline,
15 weeks, 6 and 12 months). Potential risks for the participating patients is
classified as negligible.
De boelelaan 1117
Amsterdam 1081 HV
NL
De boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68440.029.18 |
| OMON | NL-OMON29336 |