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GRAFted Patients' anxieTY Report (GRAFTY)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675997
Recruitment Status : Completed
First Posted : September 18, 2018
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire

Brief Summary:
Autograft is a technique requiring several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. In this study, level of anxiety will be reported weekly throughout hospitalizations for autologous transplant, to detect the most stressful period.

Condition or disease Intervention/treatment
Autologous Transplant Indication Other: HAD (Hospital Anxiety and Depression) scale

Detailed Description:

Autograft is one of hematological malignancies treatment, such as lymphoma and myeloma. This technique requires several weeks of hospitalization in a protected environment and can be a source of anxiety of different natures for patients. According to the medical and scientific report of the Biomedicine Agency in 2016, 3 043 patients were involved in an autologous transplant, which represents a significant number of patients potentially exposed to these types of anxiety.

That is why it will be interesting in this study to report weekly the level of anxiety throughout their hospitalization for the autologous transplant, to detect the most stressful period.

A validated questionnaire will be used: the HAD (Hospital Anxiety and Depression) scale of anxiety and depression.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GRAFted Patients' anxieTY Report (GRAFTY)
Actual Study Start Date : November 7, 2018
Actual Primary Completion Date : September 10, 2019
Actual Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autografted patients
Patients hospitalized in the hematological department of the Institute will complete the first day of conditioning and then weekly HAD (Hospital Anxiety and Depression) scale.
Other: HAD (Hospital Anxiety and Depression) scale
HAD (Hospital Anxiety and Depression) scale will be completed and reported by patients the first day of conditioning and then weekly from day 0 corresponding to the autograft, until their last day in the hematological department.




Primary Outcome Measures :
  1. Anxiety and depression measure [ Time Frame: 30 days ]

    The aim of this study is to measure patients anxiety and depression, using the HAD : Hospital Anxiety and Depression scale.

    Scores of the HAD scale can be defined as:

    • By adding the points of the answers: 1, 3, 5, 7, 9, 11, 13: we obtain the "Total A" which corresponds to the measure of the anxiety, then:
    • 7 or less: absence of symptomatology;
    • 8 to 10: doubtful symptomatology;
    • 11 and above: certain symptomatology.
    • By adding the points of the answers: 2, 4, 6, 8, 10, 12, 14: we obtain the "Total B" which corresponds to the measure of the depression, then:
    • 7 or less: absence of symptomatology;
    • 8 to 10: doubtful symptomatology;
    • 11 and above: certain symptomatology.

    The minimal score is 0 and the maximal total score is 42.




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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 hospitalized for autograft will be eligible.
Criteria

Inclusion Criteria:

  • Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria:

  • Incapacity to complete surveys

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): NCT03675997


Locations
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France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Investigators
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Principal Investigator: Stéphanie Morisson, MD Institut de Cancérologie Lucien Neuwirth
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Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT03675997    
Other Study ID Numbers: 2018-0202
2018-A02005-50 ( Other Identifier: ANSM )
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
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 Institut de Cancérologie de la Loire:
Autograft
Anxiety
Protected environment
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders