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GRAFted Patients' anxieTY Report

GRAFted Patients' anxieTY Report (GRAFTY)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03675997
Acronym
GRAFTY
Enrollment
30
Registered
2018-09-18
Start date
2018-11-07
Completion date
2019-10-20
Last updated
2020-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autologous Transplant Indication

Keywords

Autograft, Anxiety, Protected environment

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.

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.

Interventions

OTHERHAD (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.

Sponsors

Institut de Cancérologie de la Loire
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion criteria

* Incapacity to complete surveys

Design outcomes

Primary

MeasureTime frameDescription
Anxiety and depression measure30 daysThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026