Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant (AMA-ALLO)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Toulouse, France
- Toulouse University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Patients who participated in the AMA ALLO program at the IUCT-Oncopole transplant unit
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Study Plan
How is the study designed?
Design Details
- Observational Models: OTHER
- Time Perspectives: RETROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
outpatient assistance program
|
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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:
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of refusal for participation in the study
Time Frame: 12 months
|
Rate of patients who refused participating in the study |
12 months
|
|
Rate of ineligibility of the navigation nurse intervention files
Time Frame: 12 months
|
Rate of ineligibility of the navigation nurse intervention files (a single incomplete task out of 4 per intervention file renders the file ineligible) |
12 months
|
|
Quality of life for transplant patients
Time Frame: Baseline
|
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 |
Baseline
|
|
Quality of life for transplant patients
Time Frame: 6 months
|
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 |
6 months
|
|
Quality of life for transplant patients
Time Frame: 12 months
|
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 |
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne HUYNH, MD, University hospital of Toulouse
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/16/8771
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.