Clinical trial NCT04619810: "Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Official title: "Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: immunotherapy
lung cancer
nurse intervention program
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction. Lung cancer is very common worldwide with 2.09 million cases in 2018. Immunotherapy has become a mainstay in cancer treatment. There is insuficient knowledge about the impact of altered needs, as well as the interventions developed by the nurse that are aimed at cancer patients in immunotherapy treatment.

Objectives. Describe the needs of non-microcytic lung cancer patients in immunotherapy. And, evaluate the effectiveness of a nurse intervention program aimed at these patients in decreasing comorbidities, increasing satisfaction, early detection of symptoms and management of toxicities, quality of life and monitoring of anthropometric indicators.

Methodology. Phase 1: descriptive, cross-cutting and prospective study. Phase 2: quasi-experimental pre-post study. The sample is patients of the Hospital de la Santa Creu i Sant Pau, with non-microcytic lung cancer in treatment with Checkpoints inhibitor antibodies. The dependent variables: sociodemographic variables, clinical variables, satisfaction, quality of life, nutritional status, psychological impact, toxicities, number of unscheduled visits and health costs. Independent variable: nurse intervention program.

Implications for practice: Knowing the needs of patients in immunotherapy treatment will allow the development of a nurse care program to meet these needs and evaluate the program.


Eligibility criteria: Inclusion Criteria:

* Patient of legal age (\> or equal to 18 years), either male or female.
* Patient diagnosed with lung cancer regardless of subtype and / or stage. Except for small cell lung cancer, since this subtype of lung cancer is very different from the others and requires its own study.
* Patient receiving immunotherapy regardless of the treatment line.
* Patient who receives immunotherapy regardless of whether it is monotherapy or combination of chemotherapy.
* Patient who is able to consent to participate in the study.
* Patient who can read, understand and can communicate verbally.

Exclusion Criteria:

* Patient diagnosed with lung cancer synchronously with another neoplasm.
* Patients with speech disorders.
* Patients who do not understand or speak Spanish, Catalan or English.

Primary outcomes:
measure: Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy
timeFrame: one day
measure: Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
timeFrame: 6 months
measure: Number of immunomediated toxicities requiring hospital admission
timeFrame: 6 months
Secondary outcomes:
measure: Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Jorgina Serra López
Study officials:
References: