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

NCT ID: NCT04323605

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Hematologic Neoplasms

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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outpatient assistance program

Group Type EXPERIMENTAL

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

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne HUYNH, MD

Role: PRINCIPAL_INVESTIGATOR

University hospital of Toulouse

Locations

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Toulouse University Hospital

Toulouse, , France

Site Status

Countries

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France

Central Contacts

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Anne HUYNH, MD

Role: CONTACT

Phone: 33-531156354

Email: [email protected]

Anne HUYNH

Role: CONTACT

Email: [email protected]

Facility Contacts

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Anne Huynh, MD

Role: primary

Other Identifiers

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RC31/16/8771

Identifier Type: -

Identifier Source: org_study_id