Health TrialsbyHealthPanel

AlloLife - Life After Transplantation

ConditionsSurvivorshipStem Cell Transplant Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Essen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Combination product

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

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: Intervention:Experimental treatment 1 intervention
Group B: Control arm:No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Essen

Lead sponsor

Universität des Saarlandes

Collaborator

Institut Paoli-Calmettes

Collaborator

Medical University of Warsaw

Collaborator

University Of Perugia

Collaborator

Centre for Research and Technology Hellas

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: