Breast CancerQOLIBRYNCT02844608
Feasibility of Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon
A study testing Quality of Life Questionnaires in people with Breast Cancer and Colorectal Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Symptoms related to the disease and/or treatment are common in cancer patients and can affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be underestimated and underreported by the physician. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Lung Cancer
- What is being tested?
- Quality of Life Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 10 Mar 2016to 10 Mar 2019
- Phase
- Interventional
- 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
Who may be able to join
- Males and Females, ≥ 18 years of age
- No prior diagnosis of cancer
- Patients with newly diagnosed breast, colorectal or lung cancer
- No prior therapy for cancer except surgery
- Patients treated at University Hospital of Besançon
- Patients had given their informed consent to participate.
Who cannot join
- Patients with tumor recurrence,
- Patients with second cancer
- Patients with psychopathology or serious cognitive problems
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier régional Universitaire de Besançon
Besançon, 25000
Guillaume Mouillet, MD, 0033370632666
Ikram Es-Saad, 0033360732181
About this study
Official title: Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon
Symptoms related to the disease and/or treatment are common in cancer patients and can affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be underestimated and underreported by the physician. Measure of the HRQoL has been significantly developed in clinical trials and has become a key endpoint to assess clinical benefit of new therapeutic strategies and as prognostic factor of overall survival for several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer, prostate cancer and hepatocellular carcinoma.
Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for advanced solid tumors showed that clinical benefits were associated with symptom self-reporting during cancer care, including the improvement of the overall survival.
The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to physician, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on the perception of the patients of their HRQoL and symptoms.
Read the detailed description
The purpose of this study is to evaluate the feasibility of using in routinely clinical practice a systematic assessment of HRQoL in patients treated for a newly diagnosis cancer at the University Hospital of Besançon. It aims to define the logistic resources needed to implement this data collection and to assess its acceptability by clinicians, healthcare team and patients. This involves asking patients to complete HRQoL questionnaires at the time of an outpatient visit and generating a summary of the results made available to the healthcare provider immediately before the consultation.
In this pilot study, three cancer sites were selected: breast cancer in women, colorectal cancer and lung cancer. Patients included will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the specific module of their cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) before each visit with their physician. Results from HRQoL questionnaires will be immediately available to physician through a web-based portal during the visit. As part of the pilot phase, patients will be followed during four months while HRQoL will be pursued.
Questionnaires completion will be administrated by digital tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System; http:// www.ches.pro/) at the University Hospital of Besançon just before the visit with physician or at home via secured web-portal. This tool provides a didactic and attractive presentation of the HRQOL evaluation allowing physician a better understanding and consideration of HRQoL results. Indeed, results of a routinely assessment of HRQoL will be incorporated into the patient's electronic medical record. Physicians will be alerted if a clinically significant deterioration of at least one HRQoL dimension is observed over time and/or if the HRQoL level is significantly lower than reference/ normative data. In case of deterioration of HRQoL, physician may adapted the treatment or prescribed adapted supportive cares.
This feasibility study aims to assess the acceptability of the HRQoL assessment in routinely practice: to quantify the attrition, to observe the exhaustiveness of the measure, the compliance and the ability of the patient to complete HRQoL questionnaires and finally to evaluate both patient and clinician's satisfaction. The difficulties eventually encountered by the clinical research associate and by physicians will be also collected.
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer
- Being tested
- Quality of Life Questionnaires
- Keywords
- Health-related quality of life, Oncology clinical practice, Electronic collection
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of Life QuestionnairesOther
Patients will be asked to complete standardized HRQoL questionnaires: the EORTC QLQ-C30 with its specific module by cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) at first visit before starting treatment and then before every medical consultation during four months.
| Study group | Role | What they receive |
|---|---|---|
| Quality of Life | Other | Administration of Quality of Life questionnaires Receives: Other: Quality of Life Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of HRQOL questionnaire completion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2016 (estimated)
- Study start10 Mar 2016
- Primary completion10 Nov 2018 (estimated)
- Study completion10 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02844608
- Sponsor's protocol ID
- P/2015/274
- Acronym
- QOLIBRY
- Status last verified
- Oct 2017
- First submitted
- 22 Jul 2016
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
PubMed 26644527Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078.
PubMed 14966096Velikova G, Awad N, Coles-Gale R, Wright EP, Brown JM, Selby PJ. The clinical value of quality of life assessment in oncology practice-a qualitative study of patient and physician views. Psychooncology. 2008 Jul;17(7):690-8. doi: 10.1002/pon.1295.
PubMed 18033733Holzner B, Giesinger JM, Pinggera J, Zugal S, Schopf F, Oberguggenberger AS, Gamper EM, Zabernigg A, Weber B, Rumpold G. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring. BMC Med Inform Decis Mak. 2012 Nov 9;12:126. doi: 10.1186/1472-6947-12-126.
PubMed 23140270Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025.
PubMed 15337796Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS. Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012 Jun 1;30(16):1980-8. doi: 10.1200/JCO.2011.39.2381. Epub 2012 Apr 16.
PubMed 22508819Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.
PubMed 23598849Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689.
PubMed 25027139Gilbert JE, Howell D, King S, Sawka C, Hughes E, Angus H, Dudgeon D. Quality improvement in cancer symptom assessment and control: the Provincial Palliative Care Integration Project (PPCIP). J Pain Symptom Manage. 2012 Apr;43(4):663-78. doi: 10.1016/j.jpainsymman.2011.04.028.
PubMed 22464352Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.
PubMed 18175207Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.
PubMed 21282548Diouf M, Chibaudel B, Filleron T, Tournigand C, Hug de Larauze M, Garcia-Larnicol ML, Dumont S, Louvet C, Perez-Staub N, Hadengue A, de Gramont A, Bonnetain F. Could baseline health-related quality of life (QoL) predict overall survival in metastatic colorectal cancer? The results of the GERCOR OPTIMOX 1 study. Health Qual Life Outcomes. 2014 May 13;12:69. doi: 10.1186/1477-7525-12-69.
PubMed 24886671Mauer M, Stupp R, Taphoorn MJ, Coens C, Osoba D, Marosi C, Wong R, de Witte O, Cairncross JG, Efficace F, Mirimanoff RO, Forsyth P, van den Bent MJ, Weller M, Bottomley A. The prognostic value of health-related quality-of-life data in predicting survival in glioblastoma cancer patients: results from an international randomised phase III EORTC Brain Tumour and Radiation Oncology Groups, and NCIC Clinical Trials Group study. Br J Cancer. 2007 Aug 6;97(3):302-7. doi: 10.1038/sj.bjc.6603876. Epub 2007 Jul 3.
PubMed 17609661
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Routine Clinical Oncology Practice at the University Hospital of Besancon
- ClinicalTrials.gov ID
- NCT02844608
- Acronym / sponsor ID
- QOLIBRY / P/2015/274
- Conditions
- Breast Cancer, Colorectal Cancer, Lung Cancer
- Keywords
- Health-related quality of life, Oncology clinical practice, Electronic collection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 10 Nov 2018 (estimated)
- Study completion
- 10 Mar 2019 (estimated)
- First posted
- 26 Jul 2016 (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.
Symptoms related to the disease and/or treatment are common in cancer patients and can affect patient health-related quality of life (HRQol). Unfortunately these symptoms can be underestimated and underreported by the physician. Measure of the HRQoL has been significantly developed in clinical trials and has become a key endpoint to assess clinical benefit of new therapeutic strategies and as prognostic factor of overall survival for several cancer as in women breast cancer, glioblastomas, metastatic colorectal cancer, prostate cancer and hepatocellular carcinoma.
Moreover, a recent study conducted in patients receiving routine outpatient chemotherapy for advanced solid tumors showed that clinical benefits were associated with symptom self-reporting during cancer care, including the improvement of the overall survival.
The aim of the QOLIBRY project is to introduce the collection of HRQoL of cancer patients in daily clinical practice in the University Hospital of Besançon. Indeed, the goal is to make the HRQoL data accessible and exploitable in real time to physician, to help medical professionals to optimize their practices by adopting a holistic and personalized approach based on the perception of the patients of their HRQoL and symptoms.
Detailed description
The purpose of this study is to evaluate the feasibility of using in routinely clinical practice a systematic assessment of HRQoL in patients treated for a newly diagnosis cancer at the University Hospital of Besançon. It aims to define the logistic resources needed to implement this data collection and to assess its acceptability by clinicians, healthcare team and patients. This involves asking patients to complete HRQoL questionnaires at the time of an outpatient visit and generating a summary of the results made available to the healthcare provider immediately before the consultation.
In this pilot study, three cancer sites were selected: breast cancer in women, colorectal cancer and lung cancer. Patients included will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the specific module of their cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) before each visit with their physician. Results from HRQoL questionnaires will be immediately available to physician through a web-based portal during the visit. As part of the pilot phase, patients will be followed during four months while HRQoL will be pursued.
Questionnaires completion will be administrated by digital tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System; http:// www.ches.pro/) at the University Hospital of Besançon just before the visit with physician or at home via secured web-portal. This tool provides a didactic and attractive presentation of the HRQOL evaluation allowing physician a better understanding and consideration of HRQoL results. Indeed, results of a routinely assessment of HRQoL will be incorporated into the patient's electronic medical record. Physicians will be alerted if a clinically significant deterioration of at least one HRQoL dimension is observed over time and/or if the HRQoL level is significantly lower than reference/ normative data. In case of deterioration of HRQoL, physician may adapted the treatment or prescribed adapted supportive cares.
This feasibility study aims to assess the acceptability of the HRQoL assessment in routinely practice: to quantify the attrition, to observe the exhaustiveness of the measure, the compliance and the ability of the patient to complete HRQoL questionnaires and finally to evaluate both patient and clinician's satisfaction. The difficulties eventually encountered by the clinical research associate and by physicians will be also collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quality of Life | Other | Other: Quality of Life QuestionnairesAdministration of Quality of Life questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females, ≥ 18 years of age
- No prior diagnosis of cancer
- Patients with newly diagnosed breast, colorectal or lung cancer
- No prior therapy for cancer except surgery
- Patients treated at University Hospital of Besançon
Key exclusion criteria (3 listed)
- Patients with tumor recurrence,
- Patients with second cancer
- 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 |
|---|---|---|
| Quality of Life QuestionnairesPatients will be asked to complete standardized HRQoL questionnaires: the EORTC QLQ-C30 with its specific module by cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) at first visit before starting treatment and then before every medical consultation during four months. | Other | Quality of Life |
Primary outcome
Rate of HRQOL questionnaire completion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 26644527Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
- Background: PubMed 14966096Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078.
- Background: PubMed 18033733Velikova G, Awad N, Coles-Gale R, Wright EP, Brown JM, Selby PJ. The clinical value of quality of life assessment in oncology practice-a qualitative study of patient and physician views. Psychooncology. 2008 Jul;17(7):690-8. doi: 10.1002/pon.1295.
- Background: PubMed 23140270Holzner B, Giesinger JM, Pinggera J, Zugal S, Schopf F, Oberguggenberger AS, Gamper EM, Zabernigg A, Weber B, Rumpold G. The Computer-based Health Evaluation Software (CHES): a software for electronic patient-reported outcome monitoring. BMC Med Inform Decis Mak. 2012 Nov 9;12:126. doi: 10.1186/1472-6947-12-126.
- Background: PubMed 15337796Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004 Sep 1;22(17):3485-90. doi: 10.1200/JCO.2004.03.025.
- Background: PubMed 22508819Fisch MJ, Lee JW, Weiss M, Wagner LI, Chang VT, Cella D, Manola JB, Minasian LM, McCaskill-Stevens W, Mendoza TR, Cleeland CS. Prospective, observational study of pain and analgesic prescribing in medical oncology outpatients with breast, colorectal, lung, or prostate cancer. J Clin Oncol. 2012 Jun 1;30(16):1980-8. doi: 10.1200/JCO.2011.39.2381. Epub 2012 Apr 16.
- Background: PubMed 23598849Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21.
- Background: PubMed 25027139Kroenke K, Krebs EE, Wu J, Yu Z, Chumbler NR, Bair MJ. Telecare collaborative management of chronic pain in primary care: a randomized clinical trial. JAMA. 2014 Jul 16;312(3):240-8. doi: 10.1001/jama.2014.7689.
- Background: PubMed 22464352Gilbert JE, Howell D, King S, Sawka C, Hughes E, Angus H, Dudgeon D. Quality improvement in cancer symptom assessment and control: the Provincial Palliative Care Integration Project (PPCIP). J Pain Symptom Manage. 2012 Apr;43(4):663-78. doi: 10.1016/j.jpainsymman.2011.04.028.
- Background: PubMed 18175207Valderas JM, Kotzeva A, Espallargues M, Guyatt G, Ferrans CE, Halyard MY, Revicki DA, Symonds T, Parada A, Alonso J. The impact of measuring patient-reported outcomes in clinical practice: a systematic review of the literature. Qual Life Res. 2008 Mar;17(2):179-93. doi: 10.1007/s11136-007-9295-0. Epub 2008 Jan 4.
- Background: PubMed 21282548Berry DL, Blumenstein BA, Halpenny B, Wolpin S, Fann JR, Austin-Seymour M, Bush N, Karras BT, Lober WB, McCorkle R. Enhancing patient-provider communication with the electronic self-report assessment for cancer: a randomized trial. J Clin Oncol. 2011 Mar 10;29(8):1029-35. doi: 10.1200/JCO.2010.30.3909. Epub 2011 Jan 31.
- Background: PubMed 24886671Diouf M, Chibaudel B, Filleron T, Tournigand C, Hug de Larauze M, Garcia-Larnicol ML, Dumont S, Louvet C, Perez-Staub N, Hadengue A, de Gramont A, Bonnetain F. Could baseline health-related quality of life (QoL) predict overall survival in metastatic colorectal cancer? The results of the GERCOR OPTIMOX 1 study. Health Qual Life Outcomes. 2014 May 13;12:69. doi: 10.1186/1477-7525-12-69.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of Life Questionnaires in people with Breast Cancer and Colorectal 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 6 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 13 Oct 2017. 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 Guillaume Mouillet, MD (0033370632666, gmouillet@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of HRQOL questionnaire completion (time frame: 1 year). 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 NCT02844608, which also lists 13 linked publications.
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 13 Oct 2017.