Lung CancerNCT04857970
Routine Electronic Monitoring Of Quality Of Life -Poumon (REMOQOL-Poumon)
An observational study of Lung Cancer and Non Small Cell Lung Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Electronic HRQoL questionnaires with feedback to physicians and Paper-pencil HRQoL questionnaires w.o. feedback to physicians
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2019to Aug 2025
- 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: Patients diagnosed with locally advanced or metastatic non-small cell lung cancer + Physicians treating patients included in the study REMOQOL-Poumon
Who may be able to join
- Any patient diagnosed with locally advanced or metastatic non-small cell lung cancer
- Patients treated at University Hospital of Besançon
- No prior systemic therapy for cancer
- Males and Females, age ≥18 years old
- Patient able to complete the HRQoL questionnaires
- Patients who gave their informed consent to participate.
Show all 10Show fewer
- Inclusion Criteria for the sub cohort of patients undergoing the semi-structured interview with the researcher in psychology:
- Patients who realized 4 clinical encounters with collection of HRQoL
- For patients from experimental arm, the physician must have checked HRQoL results
- Any physician treating patients included in the study REMOQOL-Poumon
Who cannot join
- Patients with tumor recurrence
- Patients receiving oral antineoplastic therapy for whom at least monthly follow-up is not feasible
- Patients with psychopathology or serious cognitive problems
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Sophie Paget-Bailly, PhD
Virginie Westeel, MD, PhD
About this study
Official title: Impact of Routine Electronic Monitoring of Health-related Quality of Life on Care Relationship of Cancer Patients With Non-small Cell Lung Cancer, Locally Advanced or Metastatic, Systemic Treatment-naïve: a Randomized Trial
Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Collected data could be used by professionals to personalize care through for instance, orientation towards personalized supportive care; assessment of toxicities related to treatments or adapted treatments.
The aim of this study is to investigate the impact of REMOQOL on the care relationship in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are naïve for systemic treatment. To do this, the investigators want to conduct a randomized trial at the Besançon University Hospital.
Read more
Several teams are collaborating on this project: Methodology and Quality of Life Unit in Oncology (UMQVC), pneumonology and medical oncology services of the Besançon University Hospital and psychology laboratories of Franche-Comté and Burgundy Universities.
The original aspects of this research are the particular interest in the care relationship between physicians and patients, also taking an interest in the physician's experience, the strong collaboration with researchers in psychology, the use of mixed quantitative and qualitative analysis techniques as well as the design of randomized study.
Read the detailed description
REMOQOL-Poumon is an interventional, prospective, randomized study, conducted in Besançon University Hospital. Patients are randomized whether in the experimental arm or in the control arm. Intervention in experimental arm consists of administration of HRQoL questionnaires (QLQ-C30 \& QLQ-LC13) using the CHES software (Computer-based Health Evaluation System) and presentation of the HRQoL scores to physicians via colored graphics.
In control arm, HRQoL questionnaires (QLQ-C30+LC13) are administered in a paper-pencil way, without transmission of results to physicians.
Patients are followed for four encounters with HRQoL collection. The primary outcome, measured with the AREP questionnaire, is assessed after those four encounters.
At the end of the follow-up, a semi-structured interview with a researcher in psychology and concerning the care relationship is proposed to a sub-cohort of patients (around ten patients in each arm).
After each encounter, physicians are asked to answer a questionnaire on viewing and use of HRQoL scores. Every physician will be interviewed on care relationship by a researcher in psychology.
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Being tested
- Electronic HRQoL questionnaires with feedback to physicians, Paper-pencil HRQoL questionnaires w.o. feedback to physicians
- Keywords
- Cancer, Health-related quality of life, E-health, Patient-reported outcome
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic HRQoL questionnaires with feedback to physiciansOther
Use of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians
Paper-pencil HRQoL questionnaires w.o. feedback to physiciansOther
Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians
| Study group | Role | What they receive |
|---|---|---|
| Electronic HRQoL questionnaires with feedback to physicians | 40 patients allocated in this arm will answer HRQOL questionnaires using an electronic form in CHES Software. The HRQoL scores, presented as graphics, will be transmitted to physicians. Receives: Other: Electronic HRQoL questionnaires with feedback to physicians | |
| Paper-pencil HRQoL questionnaires w.o. feedback to physician | 40 patients allocated in this arm will answer HRQOL questionnaires using "pencil-paper", without transmission of the HRQoL scores to physicians. Receives: Other: Paper-pencil HRQoL questionnaires w.o. feedback to physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of care relationship, assessed for patients and physicians: AREP questionnaire
care relationship assessed with the AREP questionnaire. AREP is for "adjustment relationnel expérimenté perçu", which means experienced and perceived relational adjustment.
Measured: Month 3
Secondary outcomes (7)
Quality of care relationship, assessed for patients and physicians: semi-structured interviews
care relationship assessed with semi-structured interviews conducted by a researcher in psychology.
Measured: Month 24
Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores
Classical characteristics such as age at diagnosis, disease stage, type of treatments, HRQoL scores
Measured: Month 3
Preferences and expectations in the care relationship, assessed for patients and physicians
preferences and expectations in the care relationship assessed with the Inventory of Expectations towards the care relationship (IARSS, for Inventaire d'Attentes envers la Relation Soignant-Soigné )
Measured: Day 1
Acceptability of HRQoL collection
assessment of HRQoL collection considering usefulness, ease and user-friendliness
Measured: Month 24
intention of use of REMOQOL
Measured: Month 24
Overall survival
Time from randomization to death from any cause, assessed at end of inclusion + 2 years
Measured: Year 5
Progression-free survival
Time from randomization to disease progression or death from any cause
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start20 Feb 2019
- Primary completionNov 2021 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- University of Franche-Comté, University of Burgundy
- Responsible party
- Sponsor
- Investigators
- Virginie WESTEEL, MD PhD, Principal investigator, CHU de Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857970
- Sponsor's protocol ID
- P/2018/391
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2020
- Last updated
- 23 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Routine Electronic Monitoring of Health-related Quality of Life on Care Relationship of Cancer Patients With Non-small Cell Lung Cancer, Locally Advanced or Metastatic, Systemic Treatment-naïve: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04857970
- Acronym / sponsor ID
- P/2018/391
- Conditions
- Lung Cancer, Non Small Cell Lung Cancer
- Keywords
- Cancer, Health-related quality of life, E-health, Patient-reported outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- University of Franche-Comté, University of Burgundy
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 23 Apr 2021 (actual)
- 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.
Routine electronic monitoring of health-related quality of life (REMOQOL) consists of collecting HRQoL patients' data via an electronic device in order to provide these data to healthcare providers. Collected data could be used by professionals to personalize care through for instance, orientation towards personalized supportive care; assessment of toxicities related to treatments or adapted treatments.
The aim of this study is to investigate the impact of REMOQOL on the care relationship in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who are naïve for systemic treatment. To do this, the investigators want to conduct a randomized trial at the Besançon University Hospital.
Several teams are collaborating on this project: Methodology and Quality of Life Unit in Oncology (UMQVC), pneumonology and medical oncology services of the Besançon University Hospital and psychology laboratories of Franche-Comté and Burgundy Universities.
The original aspects of this research are the particular interest in the care relationship between physicians and patients, also taking an interest in the physician's experience, the strong collaboration with researchers in psychology, the use of mixed quantitative and qualitative analysis techniques as well as the design of randomized study.
Detailed description
REMOQOL-Poumon is an interventional, prospective, randomized study, conducted in Besançon University Hospital. Patients are randomized whether in the experimental arm or in the control arm. Intervention in experimental arm consists of administration of HRQoL questionnaires (QLQ-C30 \& QLQ-LC13) using the CHES software (Computer-based Health Evaluation System) and presentation of the HRQoL scores to physicians via colored graphics.
In control arm, HRQoL questionnaires (QLQ-C30+LC13) are administered in a paper-pencil way, without transmission of results to physicians.
Patients are followed for four encounters with HRQoL collection. The primary outcome, measured with the AREP questionnaire, is assessed after those four encounters.
At the end of the follow-up, a semi-structured interview with a researcher in psychology and concerning the care relationship is proposed to a sub-cohort of patients (around ten patients in each arm).
After each encounter, physicians are asked to answer a questionnaire on viewing and use of HRQoL scores. Every physician will be interviewed on care relationship by a researcher in psychology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic HRQoL questionnaires with feedback to physicians | – | Other: Electronic HRQoL questionnaires with feedback to physicians40 patients allocated in this arm will answer HRQOL questionnaires using an electronic form in CHES Software. The HRQoL scores, presented as graphics, will be transmitted to physicians. |
| Paper-pencil HRQoL questionnaires w.o. feedback to physician | – | Other: Paper-pencil HRQoL questionnaires w.o. feedback to physicians40 patients allocated in this arm will answer HRQOL questionnaires using "pencil-paper", without transmission of the HRQoL scores to physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with locally advanced or metastatic non-small cell lung cancer + Physicians treating patients included in the study REMOQOL-Poumon
Key inclusion criteria (10 listed)
- Any patient diagnosed with locally advanced or metastatic non-small cell lung cancer
- Patients treated at University Hospital of Besançon
- No prior systemic therapy for cancer
- Males and Females, age ≥18 years old
- Patient able to complete the HRQoL questionnaires
Key exclusion criteria (3 listed)
- Patients with tumor recurrence
- Patients receiving oral antineoplastic therapy for whom at least monthly follow-up is not feasible
- Patients with psychopathology or serious cognitive problems
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 |
|---|---|---|
| Electronic HRQoL questionnaires with feedback to physiciansUse of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians | Other | Electronic HRQoL questionnaires with feedback to physicians |
| Paper-pencil HRQoL questionnaires w.o. feedback to physiciansUse of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians | Other | Paper-pencil HRQoL questionnaires w.o. feedback to physician |
Primary outcome
quality of care relationship, assessed for patients and physicians: AREP questionnaire
Time frame: Month 3
care relationship assessed with the AREP questionnaire. AREP is for "adjustment relationnel expérimenté perçu", which means experienced and perceived relational adjustment.
7 secondary outcomes
Quality of care relationship, assessed for patients and physicians: semi-structured interviews
Time frame: Month 24
Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores
Time frame: Month 3
Preferences and expectations in the care relationship, assessed for patients and physicians
Time frame: Day 1
Acceptability of HRQoL collection
Time frame: Month 24
intention of use of REMOQOL
Time frame: Month 24
Overall survival
Time frame: Year 5
Progression-free survival
Time frame: Year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Virginie WESTEEL, MD PhD principal investigator
CHU de Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Non Small Cell Lung Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 10 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie PAGET BAILLY, PhD (0033370632176, spaget@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of care relationship, assessed for patients and physicians: AREP questionnaire (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2021.