Hematologic NeoplasmsAMA-ALLONCT04323605
Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant
An observational study of Hematologic Neoplasms, run by University Hospital, Toulouse at 1 site in France.
Trial summary
After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Neoplasms
- What is being tested?
- Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2022to 14 Aug 2023
- 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 who participated in the AMA ALLO program at the IUCT-Oncopole transplant unit
Who may be able to join
- Adult patients over 18 years of age
- Having received an allogeneic hematopoietic stem-cell transplant
- In full remission
- Outpatients
- Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months
- Affiliated with the social security system
Who cannot join
- Transplant patients not having given their informed consent for inclusion in AMA-ALLO
- Hospitalized or non-outpatient transplant patients
- Post-transplant patients in cytological relapse
- Patients under a legal regime of adult protection (guardianship, curatorship, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study
After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.
- Conditions
- Hematologic Neoplasms
- Being tested
- Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse
- Keywords
- allogeneic hematopoietic stem-cell transplant, outpatient assistance, "navigation" nurse
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurseOther
Integration of a post-transplant "navigation" nurse starting at the first post-transplant consultation (starting from D100 +/- 10 days post-transplant). Different times for post-transplant telephone monitoring (every week for the first 2 months, then every 15 days for the next 3 months then once a month for 7 months)
| Study group | Role | What they receive |
|---|---|---|
| outpatient assistance program | Not described Receives: Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with all the navigation nurse intervention files received at 100%
Rate of patients with all the navigation nurse intervention files received at 100%.
A file is received at 100% if the 4 following tasks are fully completed:
- - patient called by nurse (and response from the patient at the set telephone appointment)
- - completion of medical-psycho-social questionnaire (AMA-ALLO phone call form) by nurse with the patient's responses
- - information and transmission of questionnaire results by nurse to the transplant physician
- - physician/nurse decision for potential intervention (specialized consultation, consultation with the transplant physician, hospitalization, modification of treatments, additional exams to carry out, etc.)
Measured: 12 months
Secondary outcomes (5)
Rate of refusal for participation in the study
Rate of patients who refused participating in the study
Measured: 12 months
Rate of ineligibility of the navigation nurse intervention files
Rate of ineligibility of the navigation nurse intervention files (a single incomplete task out of 4 per intervention file renders the file ineligible)
Measured: 12 months
Quality of life for transplant patients
Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much
Measured: Baseline
Quality of life for transplant patients
Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much
Measured: 6 months
Quality of life for transplant patients
Quality of life for transplant patients is assessed with the Functional Assessment of Cancer Therapy--Leukemia (FACT-Leu) questionnaire version 4. Fo each question, the 5 modality answers are: 0=not all, 1= a little bit, 2=somewhat, 3=quite a bit, 4=very much
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start28 Apr 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne HUYNH, MD, Principal investigator, University hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323605
- Sponsor's protocol ID
- RC31/16/8771
- Acronym
- AMA-ALLO
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2020
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04323605
- Acronym / sponsor ID
- AMA-ALLO / RC31/16/8771
- Conditions
- Hematologic Neoplasms
- Keywords
- allogeneic hematopoietic stem-cell transplant, outpatient assistance, "navigation" nurse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 26 Mar 2020 (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.
After the initial monitoring period during hospitalization and isolation, patients with recent transplants are regularly monitored in monthly consultations but are still fragile, immunosuppressed and undergoing many treatments. The implementation of an outpatient assistance program for transplant patients should be feasible and allow for the improvement in medical-psycho-social care for the patients during this fragile and risky period, improve the satisfaction and quality of life for these transplant patients and assist in their socio-professional and familial reintegration.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| outpatient assistance program | – | Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who participated in the AMA ALLO program at the IUCT-Oncopole transplant unit
Key inclusion criteria (6 listed)
- Adult patients over 18 years of age
- Having received an allogeneic hematopoietic stem-cell transplant
- In full remission
- Outpatients
- Having given their informed consent for the participation in the outpatient assistance program with a navigation nurse (AMA-ALLO) at the first post-transplant consultation (starting on Day 100 +/- 10 days post-transplant i.e., when the patient passes the initial post-transplant monitoring period in hospitalization (conventional or by day) to the monitoring period in monthly medical consultations) and continuing for 12 months
Key exclusion criteria (4 listed)
- Transplant patients not having given their informed consent for inclusion in AMA-ALLO
- Hospitalized or non-outpatient transplant patients
- Post-transplant patients in cytological relapse
- Patients under a legal regime of adult protection (guardianship, curatorship, etc.)
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 |
|---|---|---|
| Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurseIntegration of a post-transplant "navigation" nurse starting at the first post-transplant consultation (starting from D100 +/- 10 days post-transplant). Different times for post-transplant telephone monitoring (every week for the first 2 months, then every 15 days for the next 3 months then once a month for 7 months) | Other | outpatient assistance program |
Primary outcome
Rate of patients with all the navigation nurse intervention files received at 100%
Time frame: 12 months
Rate of patients with all the navigation nurse intervention files received at 100%. A file is received at 100% if the 4 following tasks are fully completed: 1. - patient called by nurse (and response from the patient at the set telephone appointment) 2. - completion of medical-psycho-social questionnaire (AMA-ALLO phone call form) by nurse with the patient's responses 3. - information and transmission of questionnaire results by nurse to the transplant physician 4. - physician/nurse decision for potential intervention (specialized consultation, consultation with the transplant physician, hospitalization, modification of treatments, additional exams to carry out, etc.)
5 secondary outcomes
Rate of refusal for participation in the study
Time frame: 12 months
Rate of ineligibility of the navigation nurse intervention files
Time frame: 12 months
Quality of life for transplant patients
Time frame: Baseline
Quality of life for transplant patients
Time frame: 6 months
Quality of life for transplant patients
Time frame: 12 months
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 5 Nov 2026.
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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.
Anne HUYNH, MD principal investigator
University hospital of Toulouse
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 Hematologic Neoplasms, run by University Hospital, Toulouse 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 6 inclusion and 4 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 5 Nov 2026. 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?
Rate of patients with all the navigation nurse intervention files received at 100% (time frame: 12 months). 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 5 Nov 2026.