GRAFted Patients' anxieTY Report

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autologous Transplant Indication Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion criteria

Incapacity to complete surveys

Treatment and study plan

HAD (Hospital Anxiety and Depression) scale

Other

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de la Loire

Other

Registry information

Official study title

GRAFted Patients' anxieTY Report (GRAFTY)

Acronym: GRAFTY

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Sep 18, 2018
Registry last updated: Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed