"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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2024-01-25

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention arm

quasi-experimental pre-post study

Group Type OTHER

Nurse intervention program

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Jorgina Serra López

Barcelona, , Spain

Site Status

Countries

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Spain

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.

Reference Type DERIVED
PMID: 39892201 (View on PubMed)

Other Identifiers

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IIBSP-IIE-2020-77

Identifier Type: -

Identifier Source: org_study_id

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