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AlloLife – Life After Transplantation

Studies

Study First Submitted Date 2021-09-20
Study First Posted Date 2021-10-21
Last Update Posted Date 2021-11-16
Start Month Year March 2024
Primary Completion Month Year December 2025
Verification Month Year November 2021
Verification Date 2021-11-30
Last Update Posted Date 2021-11-16

Detailed Descriptions

Sequence: 20838214
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.

Conditions

Sequence: 52469960 Sequence: 52469961
Name Survivorship Name Stem Cell Transplant Complications
Downcase Name survivorship Downcase Name stem cell transplant complications

Id Information

Sequence: 40372823
Id Source org_study_id
Id Value 20210920H

Design Groups

Sequence: 55925186 Sequence: 55925187
Group Type Experimental Group Type No Intervention
Title Intervention: Title Control arm:
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. Description Wearable device for patients together with a basic patient app providing feedback on the wearable device records and patient information material.

Interventions

Sequence: 52780221
Intervention Type Combination Product
Name Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps
Description Patient-centered, technology-supported integrated survivorship- and care management

Design Outcomes

Sequence: 178499973
Outcome Type primary
Measure Quality of Life as measured by the FACT-BMT score
Time Frame 12 months
Description 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.

Sponsors

Sequence: 48596946 Sequence: 48596947 Sequence: 48596948 Sequence: 48596949 Sequence: 48596950 Sequence: 48596951
Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER Agency Class OTHER
Lead Or Collaborator lead Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator Lead Or Collaborator collaborator
Name University Hospital, Essen Name Universität des Saarlandes Name Institut Paoli-Calmettes Name Medical University of Warsaw Name University Of Perugia Name Centre for Research and Technology Hellas

Central Contacts

Sequence: 12085248
Contact Type primary
Name Norbert Graf, MD
Phone +49- 6841/16-28397
Email norbert.graf@uks.eu
Role Contact

Design Group Interventions

Sequence: 68559055
Design Group Id 55925186
Intervention Id 52780221

Eligibilities

Sequence: 30936802
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria 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
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254231323
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 1

Designs

Sequence: 30682425
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Supportive Care
Time Perspective
Masking Single
Subject Masked True

Responsible Parties

Sequence: 29049153
Responsible Party Type Sponsor