GRAFted Patients' anxieTY Report

Autologous Transplant Indication Clinical Trial

— GRAFTY  

Official title:

GRAFted Patients' anxieTY Report (GRAFTY)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03675997
• Other study ID #: 2018-0202
• Secondary ID: 2018-A02005-50
• Status: Completed
• Start date: November 7, 2018
• Est. completion date: October 20, 2019

Study information

• Verified date: January 2020
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 20, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria:

• Incapacity to complete surveys

Related Conditions & MeSH terms

• Anxiety Disorders
• Autologous Transplant Indication

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and depression measure	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.	30 days