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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619810
• Other study ID #: IIBSP-IIE-2020-77
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: January 25, 2024

Study information

• Verified date: June 2024
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 25, 2024
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Nurse intervention program
Implementation of a specific care program for patients receiving immunotherapy for lung cancer

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Jorgina Serra López	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy	Detect 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.	one day
Primary	Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)	Assess 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)	6 months
Primary	Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale	Assess 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.	6 months
Primary	Number of immunomediated toxicities requiring hospital admission	Record the number and type of toxicities that require hospital admission for its management.	6 months
Secondary	Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment	Through 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.	6 months