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

NCT04619810 | Completed

• 1 other identifier: IIBSP-IIE-2020-77
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

immunotherapy; lung cancer; nurse intervention program

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Number of immunomediated toxicities requiring hospital admission

  Record the number and type of toxicities that require hospital admission for its management.

  6 months

Secondary Outcomes (1)

• Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment

  6 months

Study Arms (1)

Intervention arm

OTHER

quasi-experimental pre-post study

Other: Nurse intervention program

Interventions

Nurse intervention program OTHER

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

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (2)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Jorgina Serra López

Barcelona, 08041, Spain

Location

Related Publications (1)

• Serra-Lopez J, Pujol-Besora C, Martinez-Recio S, Barba A, Riudavets Melia M, Sullivan I, Torralbas-Ortega J, Llado-Jordan G, Majem M, Martinez-Momblan MA. Clinical and economic impact of the advanced practice nurse in lung cancer patients receiving immunotherapy-based treatments: A quantitative study. Eur J Oncol Nurs. 2025 Feb;74:102809. doi: 10.1016/j.ejon.2025.102809. Epub 2025 Jan 23.

  PMID: 39892201 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: November 6, 2020
• Study Start: November 20, 2020
• Primary Completion: October 10, 2023
• Study Completion: January 25, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-06

Locations

ES (2)