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

NCT04323605 | Unknown

• 1 other identifier: RC31/16/8771
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Neoplasms

Keywords

allogeneic hematopoietic stem-cell transplant; outpatient assistance; "navigation" nurse

Outcome Measures

Primary Outcomes (1)

• 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: 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.)

  12 months

Secondary Outcomes (5)

• Rate of refusal for participation in the study

  12 months

• Rate of ineligibility of the navigation nurse intervention files

  12 months

• Quality of life for transplant patients

  Baseline

• Quality of life for transplant patients

  6 months

• Quality of life for transplant patients

  12 months

Study Arms (1)

outpatient assistance program

EXPERIMENTAL

Other: Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse

Interventions

Outpatient assistance program for transplant patients (AMA-ALLO) based on a "navigation" nurse OTHER

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)

outpatient assistance program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hospitalized or non-outpatient transplant patients
• Post-transplant patients in cytological relapse
• Patients under a legal regime of adult protection (guardianship, curatorship, etc.)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Toulouse University Hospital

Toulouse, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Anne HUYNH, MD

  University hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne HUYNH, MD

CONTACT

33-531156354; huynh.anne@iuct-oncopole.fr

Anne HUYNH

CONTACT

huynh.anne@iuct-oncopole.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-12

Locations

FR (1)