Observational Prospective Study of Quality of Life in Unresectable TNM Stage III NSCLC (OBSTINATE)

Condition(s) studied

Investigational drug(s) / intervention(s)

Quality of Life Questionnaire-Core 30 (QLQ-C30): The HR-QoL evaluation is based on three self-assessment questionnaires distributed to the patients according to the pre-specified data collection schedule. Patients will also complete an additional questionnaire on socio-economic and occupational outcomes

Study summary

OBSTINATE is an observational, national, prospective, multicentric study on Quality of life in patients with unresecable stade III non-small cell lung cancers.

Locally advanced non-small cell lung cancers (NSCLCs with a Tumor, Node and Metastasis \[TNM\] stage III) patients represent approximately a third of newly discovered NSCLCs every year, and a very heterogeneous group of clinical situations. Therapies are multidisciplinary and very heterogeneous across oncology centers. Patients with locally advanced NSCLC have a high symptom burden that is known to affect their quality of life. Health-related quality of life (HR-QoL) is a specific and multidimensional type of patient-reported outcome (PRO) related to the physical, psychological and social impact of the disease and its treatment as perceived by patients. HR-QoL allows, together with data of efficacy and safety, a more complete assessment of risks and benefits of each treatment. Therefore, QoL maintenance is a valuable consideration for treatment decisions, especially in the rapidly evolving therapeutic landscape of unresectable NSCLC.

The study is designed to collect PROs HR-QoL data from every new patient diagnosed with an unresectable stage III NSCLC over a period of 18 months. We also aim to describe clinical characteristics of these patients, the therapeutic strategies conducted, and outcomes in a "real-word" oncological practice.

Eligibility

Primary outcome measure(s)

• QLQ-C30 (defined as the outcomes of a clinical intervention obtained by the patient) — Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
  Change in patient's QLQ-C30 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.
• QLQ-LC13 (defined as the outcomes of a clinical intervention obtained by the patient) — Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
  Change in patient's QLQ-LC13 during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.
• EQ5D-5L (defined as the outcomes of a clinical intervention obtained by the patient) — Up to 6,5 years (18 months of recruitment + 5 years). For Cohort 1 & 2, a follow-up post progression is planned
  Change in patient's EQ5D-5L during treatment and follow-up until confirmed progression, loss of follow-up or end of the study compared to Baseline in patients diagnosed with unresectable stage III NSCLC in a "real-world" oncological practice. This evaluation is based on self-assess questionnaire distributed to the patients according to pre-specified data collection schedule. The primary objective will be addressed in the cohort as a whole, and independently for every cohort of interest.

Trial sites (34)

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