AlloLife - Life After Transplantation

University Hospital Essen

Status: Not yet enrolling

Conditions: Survivorship; Stem Cell Transplant Complications

Treatments: Combination Product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps

Study type: Interventional

Funder types: Other

Identifiers

NCT05087784

20210920H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 2 patient groups

Intervention:

Experimental group

Description:

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.

Treatment:

Combination Product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps

Control arm:

No Intervention group

Description:

Wearable device for patients together with a basic patient app providing feedback on the wearable device records and patient information material.