Quality of life in advance stage lung cancer

Long-term Patient Related OuTcomEs in lung Cancer Treatment (PROTECT): Influence of patient decisions on QOL, functionality and survival.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22982

Enrollment

500

Registered

2018-06-04

Start date

2018-11-27

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer and quality of life Longkanker en kwaliteit van leven

Interventions

NONE (observational study of regular care)

Eligibility

Inclusion criteria

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

Exclusion criteria: First line of cancer treatment for stage III or IV started in another hospital.

Design outcomes

Primary

Measure	Time frame
1) QOL as assessed by questionnaires (QLQ-C30, QLQ-LC13) (sum scores and different subdomains).	—

Secondary

Measure	Time frame
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) (rankings and subdomain scores). 4) QOL (QLQ-C30, QLQ-LC13, QODDQ/EuroQ2), treatment satisfaction / decision regret (CTSQ / DRS) and treatment motives (OPT). Other study parameters 4A. For endpoints 1), 2) and 3), patient and disease characteristics (see parameters under 5.2) will be assessed as potential predictors. 4B. 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. 4C. 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.	—

Measure

Time frame

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) (rankings and subdomain scores). 4) QOL (QLQ-C30, QLQ-LC13, QODDQ/EuroQ2), treatment satisfaction / decision regret (CTSQ / DRS) and treatment motives (OPT). Other study parameters 4A. For endpoints 1), 2) and 3), patient and disease characteristics (see parameters under 5.2) will be assessed as potential predictors. 4B. 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. 4C. 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.

—

Contacts

Public ContactR.G.P. Gijtenbeek

Medical Centre Leeuwarden, Department of Respiratory Medicine

rolof.gijtenbeek@znb.nl+31582867752

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)