GRAFted Patients' anxieTY Report
GRAFTY
2 other identifiers
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2019
CompletedJanuary 29, 2020
January 1, 2020
10 months
September 17, 2018
January 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
Patients hospitalized for autograft will be eligible.
You may qualify if:
- Autograft indication according to the Multidisciplinary Concertation Meeting
You may not qualify if:
- Incapacity to complete surveys
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stéphanie Morisson, MD
Institut de Cancérologie Lucien Neuwirth
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2018
First Posted
September 18, 2018
Study Start
November 7, 2018
Primary Completion
September 10, 2019
Study Completion
October 20, 2019
Last Updated
January 29, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share