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

Hematologic Neoplasms Clinical Trial

— AMA-ALLO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04323605
• Other study ID #: RC31/16/8771
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: February 2022

Study information

• Verified date: December 2020
• Source: University Hospital, Toulouse
• Contact: Anne HUYNH, MD
• Phone: 33-531156354
• Email: huynh.anne[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

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)

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of refusal for participation in the study	Rate of patients who refused participating in the study	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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