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Quality of Life in Lymphoma Patients One Year Post-chemotherapy (QUALIPSO-L)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187118
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Collaborators:
Force Hémato
Hospitalidee
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
Malignant lymphomas are considered as among the most chemo-sensitive cancers. ML are cured in more than 85% of patient, the majority with complete response. After this active phase of treatment, patients are in "after cancer period". Toulouse University Hospital developed since 2006 the Ambulatory Medical Assistance for After Cancer program on lymphoma patient. Ambulatory Medical Assistance for After Cancer is very efficient for detecting physical and psychological complications which impact quality of life. The investigators identified 22% of lymphoma patients who had a reduced quality of life one year after the end of chemotherapy. The present study aims to investigate the evolution of observed complications and identify cancer care pathway which decrease the quality of life reduction risk in patients one year after lymphoma chemotherapy.

Condition or disease Intervention/treatment
Lymphoma Other: Quality of life

Detailed Description:
Quality of life, as well anxiety, depression, social isolation, fear of cancer recurrence, post traumatic stress, will be measured in lymphoma patients, after a first line chemotherapy. Care cancer pathway will be also evaluated. Self-administered questionnaires will be performed on website (www.hospitalidee.fr) after inclusion and 12 months after.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in Lymphoma Patients and Cancer Care Pathway One Year Post-chemotherapy
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Group/Cohort Intervention/treatment
Lymphoma patients
Patients being in complete response after a first therapy for malignant lymphoma.
Other: Quality of life
Quality of life one year post chemo-therapy




Primary Outcome Measures :
  1. Quality of life change: Quality of Life-C30 French version [ Time Frame: Change from baseline quality of life at 12 month ]
    Health-related quality of life is evaluated by the use of Quality of Life-C30 French version



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lymphoma
Criteria

Inclusion Criteria:

  • Patients being in complete response after a first therapy for lymphoma
  • Malignant lymphoma (Hodgkin or non-Hodgkin) treated by anthracyclines with a minimum of 6 cycles, followed or not by autologous hematopoietic stem cell transplantation
  • Patients informed of the study and not opposed to the research

Exclusion Criteria:

  • Patients under legal guardian .
  • Patients unavailable to formulate non-opposition to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04187118


Contacts
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Contact: Loïc YSEBAERT, MD, PhD 561145940 ysebaert.loic@iuct-oncopole.fr
Contact: Fabien DESPAS, Pharm, PhD 561145940 ext 33 fabien.despas@univ-tlse3.fr

Sponsors and Collaborators
University Hospital, Toulouse
Force Hémato
Hospitalidee
Investigators
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Principal Investigator: Loïc YSEBAERT, MD, PhD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04187118    
Other Study ID Numbers: RC31/19/0295
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Lymphoma
Quality Of Life
Cancer Care Pathway
Post-Chemotherapy
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases