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Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy

Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04619810
Enrollment
130
Registered
2020-11-06
Start date
2020-11-20
Completion date
2024-01-25
Last updated
2024-07-23

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

Conditions

Lung Cancer

Keywords

immunotherapy, lung cancer, nurse intervention program

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.

Interventions

OTHERNurse intervention program

Implementation of a specific care program for patients receiving immunotherapy for lung cancer

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapyone dayDetect the altered needs of patients with lung cancer in immunotherapy treatment. In order to outline the best intervention program that suits their needs. Through assessment through scales and questionnaires.
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)6 monthsAssess the patient's level of anxiety from diagnosis and prior to initiating treatment up to 6 months after initiating treatment. Using the Hospital Anxiety and Depression Scale (HADS)
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale6 monthsAssess the quality of life of lung cancer patients from before starting immunotherapy up to 6 months after starting it. Through the EORTC QLQ-LC 30.
Number of immunomediated toxicities requiring hospital admission6 monthsRecord the number and type of toxicities that require hospital admission for its management.

Secondary

MeasureTime frameDescription
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment6 monthsThrough the Nutriscore scale and to records of specific values of the blood analysis of the nutritional status of patients with lung cancer before starting immunotherapy and 6 months after starting it.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026