Primary objective1) To assess and compare overall QOL during each subsequent line and type of therapy.Secondary objectives:2) To assess and compare therapy satisfaction / decision regret during each subsequent line and type of therapy.3) To assess…
ID
Source
Brief title
Condition
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
1) QOL as assessed by questionnaires (QLQ-C30, QLQ-LC13) (sum scores and
different subdomains).
Secondary outcome
Secondary endpoints
2) Treatment satisfaction / decision regret as assessed by questionnaires
(CTSQ / DRS) (sum scores and different subdomains).
3) Treatment motives as assessed by questionnaire (OPT) (subdomain scores).
4) QOL (QLQ-C30, QLQ-LC13), treatment satisfaction / decision regret (CTSQ /
DRS) and treatment motives (OPT).
Other study parameters
4D. For endpoints 1), 2) and 3), patient and disease characteristics (see
parameters under 5.2) will be assessed as potential predictors.
4E. For secondary endpoint 2), treatment motives (OPT-score), decision control
(CPS), symptom burden (QLQ-LC13), treatment tolerance / efficacy and QOL
(QLQ-C30) will be assess as additional potential predictors.
4F. For secondary endpoint 3), symptom burden (QLQ-LC13), treatment tolerance /
efficacy and quality of life (QLQ-C30, QODDQ/EuroQ2) will be assess as
additional potential predictors.
Background summary
Annually more than 12.000 patients are diagnosed with lung cancer in the
Netherlands and those numbers are increasing. Non-small cell lung cancer
(NSCLC) is accounting for 75% of all cases. At time of diagnosis, approximately
50% of all patients already have advanced disease and can only be treated with
systemic therapies (chemotherapy, targeted therapy, immunotherapy or
radiotherapy alone) or best supportive care. Since these therapies result in
only small improvements in survival rates and may frequently lead to adverse
events with a negative impact on quality of life (QOL) a good risk-benefit
weighing is of great importance to help an individual patient in decision
making. Yet, de clues to make the right decisions are far from clear. For
proper decision making and preventing regret of choices patients and doctors
need more information.
In the recent years, insights in optimizing cancer care are changing and QOL is
emerging as an important outcome. This is meaningful because for patients, the
impact of treatment on active life expectancy may be as important as extension
of life itself.
The main objective of this study is to gain insight in the quality of life of a
real-life population of stage III-IV NSCLC patients treated with systemic
therapy (in case of stage III in intention curative) or supportive care, in the
period from diagnosis (baseline) till death or discontinuation of follow up.
Study objective
Primary objective
1) To assess and compare overall QOL during each subsequent line and type of
therapy.
Secondary objectives:
2) To assess and compare therapy satisfaction / decision regret during each
subsequent line and type of therapy.
3) To assess and compare treatment motives at start and during of each
subsequent line and type of therapy.
4) To identify predictors of overall QOL, therapy satisfaction / decision
regret and treatment motives during each subsequent line and type of therapy.*
Study design
This study is a prospective single centre cohort study.
Study burden and risks
The burden associated with this study includes repeatedly filling in
questionnaires. At baseline, patients characteristics will be documented and
several questionnaires will be completed. Subsequently, every six weeks a
series of additional questionnaires will be distributed. This six weeks
frequency will be synchronized with normal clinical follow up, which is
scheduled every 3 weeks for patients receiving chemotherapy or 2 weeks for
patients receiving immunotherapy. Follow-up is designed such that the majority
can be done online via MijnMCL or collected via EPIC and will not interfere
with regular care. The after-death questionnaire will then be send to a
relative (registered at baseline) three weeks after decease.
The risk and discomfort of these study is neglectable. Filling in the repeated
questionnaires will cost some time (approximately one hour per six weeks).
The results of this study may be important for future lung cancer patients, as
it may help to understand the relationship between cancer treatment and quality
of life and quality of death, so that future patients can helped making
important treatment decisions.
H. Dunantweg 2
Leeuwarden 8934AD
NL
H. Dunantweg 2
Leeuwarden 8934AD
NL
Listed location countries
Age
Inclusion criteria
Newly diagnosed stage III or IV lung cancer, both histopathological proven as clinical diagnosis in patients not able to undergo invasive diagnostics.
Patients must be able to understand and complete protocol requirements, Instructions, and questionnaires provided in Dutch
Exclusion criteria
First line of cancer treatment for stage III or IV started in another hospital
Design
Recruitment
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 |
|---|---|
| CCMO | NL63466.099.17 |