AlloLife - Life After Transplantation (AlloLife)

AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation

Survivors of allo HCT can experience long-term survival, which is however limited by a number of late effects. These will be addressed in AlloLife to improve quality of life (QoL) and survival.

Study Overview

• Status: Not yet recruiting
• Conditions: Survivorship; Stem Cell Transplant Complications
• Intervention / Treatment: Combination product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps

Detailed Description

The complex intervention in AlloLife will consist of a set of technically-supported tools that will enable active care management through the patient and treating physician to improve QoL.

• Study Type: Interventional
• Enrollment (Anticipated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Norbert Graf, MD; Phone Number: +49- 6841/16-28397; Email: norbert.graf@uks.eu

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:

• Age > 18
• Patients with performed allogeneic stem cell transplantation any type of donor, stem cell source, GVHD prophylaxis or conditioning regimen and at least at day +20 after HCT.
• Hematologic Remission after HCT at study entrance, MRD positive patients are allowed to enter the study
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
• Signature of informed and written consent by the subject or by the subject's legally acceptable representative for patients under guardianship or trusteeship to participate in the study
• Access to an internet connected device (smartphone/tablet/computer)
• Able to understand and communicate in the respective language
• Consent to use a wearable device through the time of the study
• Consent to use a chatbot application for both healthcare data exchange and psychologic intervention

Exclusion Criteria:

• Missing consent to use a wearable device and contribute personal data collected at the point of life to the study
• ECOG performance status of 4
• Relapse of the disease at study inclusion
• Uncontrolled systemic infection
• Diagnosis of a secondary malignancy requiring systemic therapy
• Reported ongoing severe depression or potential suicidal ideation
• Vulnerable patients such as: minor, persons deprived of liberty, persons in Intensive Care Unit unable to provided informed consent prior to the intervention
• Other ongoing interventional protocol that might interfere with the current study primary endpoint

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: Complex, technology supported survivorship intervention using wearable devices for patients, supportive patient apps and physician apps for risk prediction. Increased Cardio-oncology visits assigned to risk patients as predicted by the app.	Combination product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps; Patient-centered, technology-supported integrated survivorship- and care management
No Intervention: Control arm: Wearable device for patients together with a basic patient app providing feedback on the wearable device records and patient information material.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as measured by the FACT-BMT score	Change in QoL measured by the FACT BMT score on a continuous scale. The Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) as initially developed by McQuellon RP et al. BMT 1997. It scales between 0 (zero) and 196 on a continuous scale, where higher values refer to higher Quality of Life.	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Essen
• Collaborators: University Of Perugia; Institut Paoli-Calmettes; Medical University of Warsaw; Universität des Saarlandes; Centre for Research and Technology Hellas

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2024
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 8, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 20210920H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: The IPD Sharing Plan will be developed during the project.

Drug and device information, study documents

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