AlloLife - Life After Transplantation

Not Applicable

Not yet recruiting

• Conditions: Survivorship; Stem Cell Transplant Complications
• Interventions: Combination Product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps

• Registration Number: NCT05087784
• Lead Sponsor: University Hospital, Essen

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-10-08
• Study First Posted: 2021-10-21
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-08
• Last Update Posted: 2021-11-16
• Study Start: 2024-03
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 192

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention:	Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps	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.

Primary Outcome Measures

Name	Time	Method
Quality of Life as measured by the FACT-BMT score	12 months	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.