AlloLife - Life After Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
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Survivorship, Stem Cell Transplant Complications

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention:<br>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<br>* Patient-centered, technology-supported integrated survivorship- and care management<br>|
| No Intervention: Control arm:<br>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?
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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 |