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

F

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

Status

Completed

Conditions

Lung Cancer

Treatments

Other: Nurse intervention program

Study type

Interventional

Funder types

Other

Identifiers

NCT04619810
IIBSP-IIE-2020-77

Details and patient eligibility

About

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.

Enrollment

130 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

130 participants in 1 patient group

Intervention arm
Other group
Description:
quasi-experimental pre-post study
Treatment:
Other: Nurse intervention program

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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