AlloLife - Life After Transplantation

N/ANot Yet RecruitingNCT05087784

University Hospital, Essen192 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

192

Conditions

Survivorship Stem Cell Transplant Complications

Interventions

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

Patient-centered, technology-supported integrated survivorship- and care management

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Central Contacts

Norbert Graf, MD

CONTACT

+49- 6841/16-28397 norbert.graf@uks.eu

Data from ClinicalTrials.gov

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