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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Other: Nurse intervention program

• Registration Number: NCT04619810
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Study Start: 2020-11-20
• Primary Completion: 2023-10-10
• Study Completion: 2024-01-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Nurse intervention program	quasi-experimental pre-post study

Primary Outcome Measures

Name	Time	Method
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale	6 months	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.
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy	one day	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.
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)	6 months	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)
Number of immunomediated toxicities requiring hospital admission	6 months	Record the number and type of toxicities that require hospital admission for its management.

Secondary Outcome Measures

Name	Time	Method
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment	6 months	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.

Trial Locations

Locations (2)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Jorgina Serra López; 🇪🇸 Barcelona, Spain