"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Primary Purpose
Lung Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Nurse intervention program
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring immunotherapy, lung cancer, nurse intervention program
Eligibility Criteria
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.
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
- Jorgina Serra LópezRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intervention arm
Arm Description
quasi-experimental pre-post study
Outcomes
Primary Outcome Measures
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.
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)
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.
Number of immunomediated toxicities requiring hospital admission
Record the number and type of toxicities that require hospital admission for its management.
Secondary Outcome Measures
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment
Through the Nutriscore scale and to records of specific values of the blood analysis of the nutritional status of patients with lung cancer before starting immunotherapy and 6 months after starting it.
Full Information
NCT ID
NCT04619810
First Posted
September 21, 2020
Last Updated
January 31, 2021
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT04619810
Brief Title
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Official Title
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
immunotherapy, lung cancer, nurse intervention program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Other
Arm Description
quasi-experimental pre-post study
Intervention Type
Other
Intervention Name(s)
Nurse intervention program
Intervention Description
Implementation of a specific care program for patients receiving immunotherapy for lung cancer
Primary Outcome Measure Information:
Title
Number of altered needs of patients with lung cancer undergoing treatment with immunotherapy
Description
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.
Time Frame
one day
Title
Changes on anxiety in lung cancer patients with immunotherapy treatment measured by Hospital Anxiety and Depression Scale (HADS)
Description
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)
Time Frame
6 months
Title
Changes on quality of life in lung cancer patients with immunotherapy treatment measured by EORTC quality of life scale
Description
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.
Time Frame
6 months
Title
Number of immunomediated toxicities requiring hospital admission
Description
Record the number and type of toxicities that require hospital admission for its management.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of nutritional alterations in patients with lung cancer, who start immunotherapy treatment
Description
Through the Nutriscore scale and to records of specific values of the blood analysis of the nutritional status of patients with lung cancer before starting immunotherapy and 6 months after starting it.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorgina Serra, Nurse
Phone
+34678891527
Email
jserral@santpau.cat
First Name & Middle Initial & Last Name & Degree
Jorgina Serra
Facility Name
Jorgina Serra López
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorgina Serra López
Phone
+34678891527
Email
jserral@santpau.cat
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
"Impact of a Nursing Intervention in the Management of Oncological Patients With Lung Cancer Under Treatment With Immunotherapy"
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