AlloLife - Life After Transplantation

NCT05087784 | Not Yet Recruiting DMC

• 1 other identifier: 20210920H
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Survivorship; Stem Cell Transplant Complications

Outcome Measures

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.

  12 months

Study Arms (2)

Intervention:

EXPERIMENTAL

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

Control arm:

NO INTERVENTION

Wearable device for patients together with a basic patient app providing feedback on the wearable device records and patient information material.

Interventions

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

Intervention:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• Universität des Saarlandes: collaborator
• Institut Paoli-Calmettes: collaborator
• Medical University of Warsaw: collaborator
• University Of Perugia: collaborator
• Centre for Research and Technology Hellas: collaborator

Central Study Contacts

Norbert Graf, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 21, 2021
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 16, 2021

Record last verified: 2021-11