Routine Electronic Monitoring Of Quality Of Life -Poumon (REMOQOL-Poumon)

April 22, 2021 updated by: Centre Hospitalier Universitaire de Besancon

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • CHU de Besançon
        • Contact:
          • Sophie Paget-Bailly, PhD
        • Principal Investigator:
          • Virginie Westeel, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with locally advanced or metastatic non-small cell lung cancer + Physicians treating patients included in the study REMOQOL-Poumon

Description

Inclusion Criteria for patients:

  • 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.

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

Inclusion Criteria for physicians:

• Any physician treating patients included in the study REMOQOL-Poumon

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Electronic HRQoL questionnaires with feedback to physicians
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 physician
40 patients allocated in this arm will answer HRQOL questionnaires using "pencil-paper", without transmission of the HRQoL scores to physicians.
Other: Paper-pencil HRQoL questionnaires w.o. feedback to physicians
Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of care relationship, assessed for patients and physicians: semi-structured interviews
Time Frame: Month 24
care relationship assessed with semi-structured interviews conducted by a researcher in psychology.
Month 24
Descriptive characteristics: socio-demographic, clinic, treatments and HRQoL scores
Time Frame: Month 3
Classical characteristics such as age at diagnosis, disease stage, type of treatments, HRQoL scores
Month 3
Preferences and expectations in the care relationship, assessed for patients and physicians
Time Frame: Day 1
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 )
Day 1
Acceptability of HRQoL collection
Time Frame: Month 24
assessment of HRQoL collection considering usefulness, ease and user-friendliness
Month 24
intention of use of REMOQOL
Time Frame: Month 24
Month 24
Overall survival
Time Frame: Year 5
Time from randomization to death from any cause, assessed at end of inclusion + 2 years
Year 5
Progression-free survival
Time Frame: Year 5
Time from randomization to disease progression or death from any cause
Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Franche-Comté
University of Burgundy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Virginie WESTEEL, MD PhD, CHU de Besançon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P/2018/391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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