NCT04619810Completed
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Source: ClinicalTrials.gov · Last updated 23 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 130 (actual)
- First submitted
- 21 Sept 2020
- Start date
- 20 Nov 2020
- Primary completion date
- 10 Oct 2023
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Diseases
- Lung cancer
- NCT number
- NCT04619810
What you commit to
- Study type: Interventional
- Participants enrolled: 130
- From 20 Nov 2020 to the primary completion date, 10 Oct 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient diagnosed with lung cancer synchronously with another neoplasm.
- Patients with speech disorders.
Other
- Patients who do not understand or speak Spanish, Catalan or English.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Jorgina Serra López Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.