Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant
- Conditions
- Hematologic Neoplasms
- Interventions
- Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse
- Registration Number
- NCT04323605
- Lead Sponsor
- University Hospital, Toulouse
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description outpatient assistance program Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse -
- Primary Outcome Measures
Name Time Method Rate of patients with all the navigation nurse intervention files received at 100% 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.)
- Secondary Outcome Measures
Name Time Method Rate of ineligibility of the navigation nurse intervention files 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)
Quality of life for transplant patients 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
Rate of refusal for participation in the study 12 months Rate of patients who refused participating in the study
Trial Locations
- Locations (1)
Toulouse University Hospital
🇫🇷Toulouse, France