SurvivorshipAlloLifeNCT05087784
AlloLife - Life After Transplantation
A study testing Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps in people with Survivorship and Stem Cell Transplant Complications, run by University Hospital, Essen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Survivorship, Stem Cell Transplant Complications
- What is being tested?
- Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Survivorship, Stem Cell Transplant Complications
- Being tested
- Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study startMar 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurvivorshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität des Saarlandes, Institut Paoli-Calmettes, Medical University of Warsaw, University Of Perugia, Centre for Research and Technology Hellas
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087784
- Sponsor's protocol ID
- 20210920H
- Acronym
- AlloLife
- Status last verified
- Nov 2021
- First submitted
- 20 Sep 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The IPD Sharing Plan will be developed during the project.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AlloLife - Life After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05087784
- Acronym / sponsor ID
- AlloLife / 20210920H
- Conditions
- Survivorship, Stem Cell Transplant Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Collaborators
- Universität des Saarlandes, Institut Paoli-Calmettes, Medical University of Warsaw, University Of Perugia, Centre for Research and Technology Hellas
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: | Experimental | Combination Product: Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician appsComplex, 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician appsPatient-centered, technology-supported integrated survivorship- and care management | Combination product | Intervention: |
Primary outcome
Quality of Life as measured by the FACT-BMT score
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: Undecided. The IPD Sharing Plan will be developed during the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Technology supported, coordinated survivorship care using wearable devices, supportive patient-apps and cardio-oncology physician apps in people with Survivorship and Stem Cell Transplant Complications, run by University Hospital, Essen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Norbert Graf, MD (+49- 6841/16-28397, norbert.graf@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life as measured by the FACT-BMT score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.