GRAFted Patients' anxieTY Report (GRAFTY)

GRAFted Patients' anxieTY Report (GRAFTY)

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.

Study Overview

• Status: Completed
• Conditions: Autologous Transplant Indication
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• France
  • Saint-Priest-en-Jarez, France, 42270
    • Institut de Cancérologie Lucien Neuwirth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized for autograft will be eligible.

Description

Inclusion Criteria:

• Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria:

• Incapacity to complete surveys

Study Plan

How is the study designed?

Number of groups / cohorts

1

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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de la Loire
• Investigators: Principal Investigator: Stéphanie Morisson, MD, Institut de Cancérologie Lucien Neuwirth

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): October 20, 2019

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Anxiety; Autograft; Protected environment
• 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)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No