Autologous Transplant IndicationGRAFTYNCT03675997
GRAFted Patients' anxieTY Report
An observational study of Autologous Transplant Indication, run by Institut de Cancérologie de la Loire at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autologous Transplant Indication
- What is being tested?
- HAD (Hospital Anxiety and Depression) scale
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2018to 20 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for autograft will be eligible.
Who may be able to join
- Autograft indication according to the Multidisciplinary Concertation Meeting
Who cannot join
- Incapacity to complete surveys
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42270
About this study
Official title: 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.
Read the 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.
- Conditions
- Autologous Transplant Indication
- Being tested
- HAD (Hospital Anxiety and Depression) scale
- Keywords
- Autograft, Anxiety, Protected environment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAD (Hospital Anxiety and Depression) scaleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HAD (Hospital Anxiety and Depression) scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start7 Nov 2018
- Primary completion10 Sep 2019
- Study completion20 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Transplant IndicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Morisson, MD, Principal investigator, Institut de Cancérologie Lucien Neuwirth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675997
- Sponsor's protocol ID
- 2018-0202
- Other IDs
- 2018-A02005-50
- Acronym
- GRAFTY
- Status last verified
- Jan 2020
- First submitted
- 17 Sep 2018
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRAFted Patients' anxieTY Report (GRAFTY)
- ClinicalTrials.gov ID
- NCT03675997
- Acronym / sponsor ID
- GRAFTY / 2018-0202
- Conditions
- Autologous Transplant Indication
- Keywords
- Autograft, Anxiety, Protected environment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 20 Oct 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autografted patients | – | Other: HAD (Hospital Anxiety and Depression) scalePatients hospitalized in the hematological department of the Institute will complete the first day of conditioning and then weekly HAD (Hospital Anxiety and Depression) scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for autograft will be eligible.
Key inclusion criteria (1 listed)
- Autograft indication according to the Multidisciplinary Concertation Meeting
Key exclusion criteria (1 listed)
- Incapacity to complete surveys
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HAD (Hospital Anxiety and Depression) scaleHAD (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. | Other | Autografted patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Individual participant dataSharing planned: No
Related trials for Autologous Transplant Indication
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Pediatric and Young Adult Patientswith Hypodiploid or t(17;19) B-ALL, Infants With Very High Risk KMT2A B-ALL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Morisson, MD principal investigator
Institut de Cancérologie Lucien Neuwirth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autologous Transplant Indication, run by Institut de Cancérologie de la Loire at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression measure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.