GRAFted Patients' anxieTY Report

NCT ID: NCT03675997

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-07

Study Completion Date

2019-10-20

Brief Summary

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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

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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.

Conditions

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Autologous Transplant Indication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

HAD (Hospital Anxiety and Depression) scale

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Autograft indication according to the Multidisciplinary Concertation Meeting

Exclusion Criteria

* Incapacity to complete surveys
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de la Loire

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stéphanie Morisson, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie Lucien Neuwirth

Locations

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Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, , France

Site Status

Countries

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France

Other Identifiers

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2018-A02005-50

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0202

Identifier Type: -

Identifier Source: org_study_id

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