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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04323605
Acronym
AMA-ALLO
Enrollment
50
Registered
2020-03-26
Start date
2021-01-31
Completion date
2022-02-28
Last updated
2020-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms

Keywords

allogeneic hematopoietic stem-cell transplant, outpatient assistance, navigation nurse

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.

Interventions

OTHEROutpatient assistance program for transplant patients (AMA-ALLO) based on a navigation nurse

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)

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Rate of patients with all the navigation nurse intervention files received at 100%12 monthsRate 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

MeasureTime frameDescription
Rate of refusal for participation in the study12 monthsRate of patients who refused participating in the study
Rate of ineligibility of the navigation nurse intervention files12 monthsRate 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 patientsBaselineQuality 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

Countries

France

Contacts

Primary ContactAnne HUYNH, MD
huynh.anne@iuct-oncopole.fr33-531156354
Backup ContactAnne HUYNH
huynh.anne@iuct-oncopole.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026