NCT02844608

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2019

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.7 years

First QC Date

July 22, 2016

Last Update Submit

October 12, 2017

Conditions

Breast CancerColorectal CancerLung Cancer

Keywords

Health-related quality of lifeOncology clinical practiceElectronic collection

Outcome Measures

Primary Outcomes (1)

  • Rate of HRQOL questionnaire completion

    1 year

Study Arms (1)

Quality of Life

OTHER

Administration of Quality of Life questionnaires

Other: Quality of Life Questionnaires

Interventions

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.

Quality of Life

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with tumor recurrence,
  • Patients with second cancer
  • Patients with psychopathology or serious cognitive problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier régional Universitaire de Besançon

Besançon, 25000, France

RECRUITING

Related Publications (13)

  • 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.

    PMID: 26644527BACKGROUND

  • Velikova 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.

    PMID: 14966096BACKGROUND

  • Velikova 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.

    PMID: 18033733BACKGROUND

  • Holzner 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.

    PMID: 23140270BACKGROUND

  • Fromme 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.

    PMID: 15337796BACKGROUND

  • Fisch 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.

    PMID: 22508819BACKGROUND

  • Seow 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.

    PMID: 23598849BACKGROUND

  • Kroenke 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.

    PMID: 25027139BACKGROUND

  • Gilbert 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.

    PMID: 22464352BACKGROUND

  • Valderas 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.

    PMID: 18175207BACKGROUND

  • Berry 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.

    PMID: 21282548BACKGROUND

  • Diouf 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.

    PMID: 24886671BACKGROUND

  • Mauer 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.

    PMID: 17609661BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Guillaume Mouillet, MD

CONTACT

0033370632666gmouillet@chu-besancon.fr

Ikram Es-Saad

CONTACT

0033370632181iessaad@chu-besancon.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

July 26, 2016

Study Start

March 10, 2016

Primary Completion

November 10, 2018

Study Completion

March 10, 2019

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)