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: Unknown
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne HUYNH, MD; Phone Number: 33-531156354; Email: huynh.anne@iuct-oncopole.fr
• Study Contact Backup: Name: Anne HUYNH; Email: huynh.anne@iuct-oncopole.fr

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital
    • Contact: Anne Huynh, MD; Email: Huynh.Anne@iuct-oncopole.fr
    • Sub-Investigator: Cécile Borel, MD
    • Sub-Investigator: Sarah Guenounou, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: outpatient assistance program

Other: Outpatient 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)

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%	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Anne HUYNH, MD, University Hospital of Toulouse

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: allogeneic hematopoietic stem-cell transplant; outpatient assistance; "navigation" nurse
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: RC31/16/8771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No