- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03675997
GRAFted Patients' anxieTY Report (GRAFTY)
GRAFted Patients' anxieTY Report (GRAFTY)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Saint-Priest-en-Jarez, France, 42270
- institut de cancérologie Lucien Neuwirth
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Autograft indication according to the Multidisciplinary Concertation Meeting
Exclusion Criteria:
- Incapacity to complete surveys
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety and depression measure
Time Frame: 30 days
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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:
The minimal score is 0 and the maximal total score is 42. |
30 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Stéphanie Morisson, MD, institut de cancérologie Lucien Neuwirth
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2018-0202
- 2018-A02005-50 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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