Non-small Cell Lung CancerIMPULSONCT02336061
Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Asociación para la Investigación del Cáncer de Pulmón en Mujeres at 18 sites in Spain.
Trial summary
The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Evaluation of gender differences on the psychosocial and economic impact.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 344 participants
- Where
- 18 sitesSpain
- Study dates
- 3 Feb 2015to 30 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 1250 patients over 18 years of age (approximately 50% men/women), with metastatic NSCLC, who are going to commence first-line treatment and who have a life expectancy of over three months will be included. They will be distributed into two cohorts (men and women) at 50% and will be distributed by age group and smoking status to facilitate the homogeneity between the two cohorts.
Who may be able to join
- Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
- Patients over the age of 18
- ECOG 0-3
- Patients who have granted their informed consent, preferably in writing, but otherwise, verbal with witnesses who are independent of the research team
- Life expectancy of over three months
- Speak fluent Spanish, in order to be able to complete the study questionnaires
- Patients able to read and write with no problems
Who cannot join
- Previous systemic treatment for metastatic NSCLC. The administration of neoadjuvant or adjuvant radiotherapy and/or chemotherapy is permitted provided it was completed major or equal 6 months prior
- Dementia or a significantly altered mental state that could affect comprehension or the ability to grant informed consent
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital German Trias i Pujol
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Provincial de Castellón
Castellon, Castellón, 12006
Hospital Universitario Ramón y Cajal
Madrid, 28034
Fundación Jiménez Díaz
Madrid, 28040
Hospital Clínico Universitario San Carlos
Madrid, 28040
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07010
Hospital de Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Arnau de Villanova
Valencia, 46015
Hospital La Fe
Valencia, 46026
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
Official title: Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer.
Read the detailed description
Multi-centre, prospective follow-up post-authorisation study of two patient cohorts with metastatic NSCLC (men and women). It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. The clinical procedures for assessing the tumour and the treatment response will be performed according to the site's standard practice.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Evaluation of gender differences on the psychosocial and economic impact.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of gender differences on the psychosocial and economic impact.Behavioural
| Study group | Role | What they receive |
|---|---|---|
| male | It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. Receives: Behavioral: Evaluation of gender differences on the psychosocial and economic impact. | |
| female | It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
The procedures for assessing psychosocial impact are: Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale. These tests will be performed by the investigator at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
Measured: 2 years
Economic impact (employment status, working hours, income range, public assistance, family support ...)
The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)
Measured: 2 years
Secondary outcomes (2)
Influence of treatment (reatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment).
The procedures for assessing to influence of treatment are:Treatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment). These will be performed in line with the site's standard practice at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
Measured: 2 years
Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)
The procedures for assessing psychosocial and economic impact are: Zarit Caregiver Burden Questionnaire and Test assessing the economic impact. These will be performed in line with the site's standard practice at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start3 Feb 2015
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Why it stopped: Sponsor decision due to the low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para la Investigación del Cáncer de Pulmón en Mujeres
- Sponsor type
- University, hospital or other
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
- Investigators
- María Rosario García, MD, Study chair, Complejo Hospitalario A CoruñaPilar Garrido, MD, Study chair, Hospital Universitario Ramon y CajalNuria Viñolas, MD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336061
- Sponsor's protocol ID
- ICA-QUI-2014-01
- Acronym
- IMPULSO
- Status last verified
- Dec 2017
- First submitted
- 3 Dec 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vinolas NN, Garcia-Campelo R, Majem M, Carcereny E, Isla D, Gonzalez-Larriba JL, Coves J, De-Castro J, Domine M, Lianes P, Artal A, Remon J, Felip E, Garrido P. Assessment of the psychosocial and economic impact according to sex in non-small cell lung cancer patients: an exploratory longitudinal study. BMC Psychol. 2020 Nov 23;8(1):123. doi: 10.1186/s40359-020-00489-z.
PubMed 33228796
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT02336061
- Acronym / sponsor ID
- IMPULSO / ICA-QUI-2014-01
- Conditions
- Non-small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor decision due to the low recruitment rate
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Asociación para la Investigación del Cáncer de Pulmón en MujeresUniversity, hospital or other
- Collaborators
- Pivotal S.L.
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 12 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer.
Detailed description
Multi-centre, prospective follow-up post-authorisation study of two patient cohorts with metastatic NSCLC (men and women). It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. The clinical procedures for assessing the tumour and the treatment response will be performed according to the site's standard practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| male | – | Behavioral: Evaluation of gender differences on the psychosocial and economic impact.It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. |
| female | – | –It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1250 patients over 18 years of age (approximately 50% men/women), with metastatic NSCLC, who are going to commence first-line treatment and who have a life expectancy of over three months will be included. They will be distributed into two cohorts (men and women) at 50% and will be distributed by age group and smoking status to facilitate the homogeneity between the two cohorts.
Key inclusion criteria (7 listed)
- Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
- Patients over the age of 18
- ECOG 0-3
- Patients who have granted their informed consent, preferably in writing, but otherwise, verbal with witnesses who are independent of the research team
- Life expectancy of over three months
Key exclusion criteria (2 listed)
- Previous systemic treatment for metastatic NSCLC. The administration of neoadjuvant or adjuvant radiotherapy and/or chemotherapy is permitted provided it was completed major or equal 6 months prior
- Dementia or a significantly altered mental state that could affect comprehension or the ability to grant informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of gender differences on the psychosocial and economic impact. | Behavioural | male |
Primary outcome
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
Time frame: 2 years
The procedures for assessing psychosocial impact are: Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale. These tests will be performed by the investigator at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
Economic impact (employment status, working hours, income range, public assistance, family support ...)
Time frame: 2 years
The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)
2 secondary outcomes
Influence of treatment (reatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment).
Time frame: 2 years
Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision due to the low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Derived from this study: PubMed 33228796Vinolas NN, Garcia-Campelo R, Majem M, Carcereny E, Isla D, Gonzalez-Larriba JL, Coves J, De-Castro J, Domine M, Lianes P, Artal A, Remon J, Felip E, Garrido P. Assessment of the psychosocial and economic impact according to sex in non-small cell lung cancer patients: an exploratory longitudinal study. BMC Psychol. 2020 Nov 23;8(1):123. doi: 10.1186/s40359-020-00489-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Rosario García, MD study chair
Complejo Hospitalario A Coruña
Pilar Garrido, MD study chair
Hospital Universitario Ramon y Cajal
Nuria Viñolas, MD study chair
Hospital Clinic of Barcelona
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Asociación para la Investigación del Cáncer de Pulmón en Mujeres at 18 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision due to the low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02336061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.