"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
NCT ID: NCT04619810
Last Updated: 2024-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2020-11-20
2024-01-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention arm
quasi-experimental pre-post study
Nurse intervention program
Implementation of a specific care program for patients receiving immunotherapy for lung cancer
Interventions
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Nurse intervention program
Implementation of a specific care program for patients receiving immunotherapy for lung cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with speech disorders.
* Patients who do not understand or speak Spanish, Catalan or English.
18 Years
ALL
Yes
Sponsors
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Responsible Party
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Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Jorgina Serra López
Barcelona, , Spain
Countries
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References
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Serra-Lopez J, Pujol-Besora C, Martinez-Recio S, Barba Joaquin 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.
Other Identifiers
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IIBSP-IIE-2020-77
Identifier Type: -
Identifier Source: org_study_id
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