Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant

Study Overview
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Brief Summary
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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.

Official Title
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Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a navigation nurse


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: outpatient assistance program<br> | Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a navigation nurse<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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.) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of refusal for participation in the study | Rate of patients who refused participating in the study | 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) | 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 | 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 | 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogeneic hematopoietic stem-cell transplant, outpatient assistance, navigation nurse