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Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant (AMA-ALLO)

Primary Purpose

Hematologic Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematologic Neoplasms focused on measuring allogeneic hematopoietic stem-cell transplant, outpatient assistance, "navigation" nurse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Toulouse University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

outpatient assistance program

Arm Description

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Rate of refusal for participation in the study
Rate of patients who refused participating in the study
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)
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
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
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

Full Information

First Posted
March 24, 2020
Last Updated
December 2, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT04323605
Brief Title
Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant
Acronym
AMA-ALLO
Official Title
Implementation of an Assistance Program for Outpatients Following an Allogeneic Hematopoietic Stem-cell Transplant: Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Neoplasms
Keywords
allogeneic hematopoietic stem-cell transplant, outpatient assistance, "navigation" nurse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
outpatient assistance program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse
Intervention Description
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)
Primary Outcome Measure Information:
Title
Rate of patients with all the navigation nurse intervention files received at 100%
Description
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.)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of refusal for participation in the study
Description
Rate of patients who refused participating in the study
Time Frame
12 months
Title
Rate of ineligibility of the navigation nurse intervention files
Description
Rate of ineligibility of the navigation nurse intervention files (a single incomplete task out of 4 per intervention file renders the file ineligible)
Time Frame
12 months
Title
Quality of life for transplant patients
Description
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
Time Frame
Baseline
Title
Quality of life for transplant patients
Description
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
Time Frame
6 months
Title
Quality of life for transplant patients
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne HUYNH, MD
Phone
33-531156354
Email
huynh.anne@iuct-oncopole.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne HUYNH
Email
huynh.anne@iuct-oncopole.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne HUYNH, MD
Organizational Affiliation
University hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Huynh, MD
Email
Huynh.Anne@iuct-oncopole.fr
First Name & Middle Initial & Last Name & Degree
Anne Huynh, MD
First Name & Middle Initial & Last Name & Degree
Cécile Borel, MD
First Name & Middle Initial & Last Name & Degree
Sarah Guenounou, MD

12. IPD Sharing Statement

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

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