Hematological DiseasesAlloCareNCT06281496
AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
A study testing AlloCare in people with Hematological Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Diseases
- What is being tested?
- AlloCare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients (age> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.
Who cannot join
- Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Mette Schaufuss Engedal, MSc, +45 35450978, mette.schaufuss.engedal@regionh.dk
Mary Jarden, Professor, mary.jarden@regionh.dk
About this study
A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.
Read the detailed description
The study aims to investigate the effect of a stepped care intervention in allo-HSCT survivors on health-related quality of life and late effects.
Method:
This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase.
Population/recruitment:
Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.
Intervention:
a stepped-care multi-modal intervention
- Conditions
- Hematological Diseases
- Being tested
- AlloCare
- Keywords
- Late effects. Survivorship. Allo-HSCT
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloCareBehavioural
Survivorship supportive care
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention is a stepped-care multi-modal intervention and consists of 4 steps, including screening for vulnerability, digital health support and education. Individual consultations based on PRO data (HM-PRO) and multidisciplinary late effects management based on PRO assessment. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians. Receives: Behavioral: AlloCare |
| Control Group | No intervention | Patients in the control group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30)
Between-group changes in Quality of life - from baseline 3 months post treatment with allogenenic stem cell transplantation to postintervention 12 months post treatment with allogeneic stem cell transplantation. EORTC Quality of Life core questionnaire (QLQ-C30). The EORTC QoL Core Questionnaire EORTC QLQ-C30 is a 30-item instrument designed to measure quality of life in all cancer patients. The questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and some single items assessing additional symptoms commonly reported by cancer patients
Measured: 15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)
Secondary outcomes (4)
Survivorship specific quality of life
EORTC-QOL-SURV100, Quality of life questionnaire applicable to cancerfree survivors. It consists of 100 questions divided over thirteen functional scales (i.e. Physical; Role ; Emotional; and Cognitive functioning; Body image; Symptom awareness; Positive health behavior change; Positive life outlook; Positive impact on behavior towards others; Positive social functioning; Work; Sexual functioning; Global health status), nine symptom scales (i.e. Social isolation; Fatigue; Pain; Sleep problems; Health distress; Negative health outlook; Social interference; Sexual problems), one Symptom checklist assessing chronic side effects of cancer treatments, and twelve single items.
Score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QL represents a high QL, but a high score for a symptom item represents a high level of symptomatology.
Measured: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Health literacy
The survey encompasses nine separate scales exploring 9 different domains of health literacy. The following health literacy domains have been chosen; Scale 1: Feeling understood and supported by health care providers. Scale 3: Actively managing my health. Scale 8: Ability to find good health information and finally Scale 9: Understanding health information well enough to know what to do. The scales can be used individually as no summary score of total health literacy can be measured.
Measured: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Referrals to municipality rehabilitation
Municipal rehabilitation adresses both physical rehabilitation as well as psychosocial and work related problems based on disease and cancer treatment.
Measured: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
Validated questionnaire to measure degree of Graft Versus Host disease. The scale contains 28 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological), and a 7 day recall period. Patients report how "bothered" they feel about each symptom over the previous 7 days using a five-point Likert scale from "not at all" to "extremely". range from 0 to 100, with a higher score indicating worse symptoms
Measured: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Nov 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Model description
- One site, two arm randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Mette Schaufuss Engedal, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mette Schaufuss Engedal, MSc, Principal investigator, Rigshospitalet. Department of Hematology. DenmarkMary Jarden, Study director, Rigshospitalet. Department of Hematology. Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281496
- Sponsor's protocol ID
- Rigshospitalet, Hematology
- Acronym
- AlloCare
- Status last verified
- Jul 2025
- First submitted
- 19 Feb 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06281496
- Acronym / sponsor ID
- AlloCare / Rigshospitalet, Hematology
- Conditions
- Hematological Diseases
- Keywords
- Late effects. Survivorship. Allo-HSCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 28 Feb 2024 (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.
A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.
Detailed description
The study aims to investigate the effect of a stepped care intervention in allo-HSCT survivors on health-related quality of life and late effects.
Method:
This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase.
Population/recruitment:
Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.
Intervention:
a stepped-care multi-modal intervention
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One site, two arm randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: AlloCareThe intervention is a stepped-care multi-modal intervention and consists of 4 steps, including screening for vulnerability, digital health support and education. Individual consultations based on PRO data (HM-PRO) and multidisciplinary late effects management based on PRO assessment. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians. |
| Control Group | No intervention | –Patients in the control group will receive usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (age> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.
Key exclusion criteria (1 listed)
- Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.
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 |
|---|---|---|
| AlloCareSurvivorship supportive care | Behavioural | Intervention group |
Primary outcome
Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30)
Time frame: 15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)
Between-group changes in Quality of life - from baseline 3 months post treatment with allogenenic stem cell transplantation to postintervention 12 months post treatment with allogeneic stem cell transplantation. EORTC Quality of Life core questionnaire (QLQ-C30). The EORTC QoL Core Questionnaire EORTC QLQ-C30 is a 30-item instrument designed to measure quality of life in all cancer patients. The questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and some single items assessing additional symptoms commonly reported by cancer patients
4 secondary outcomes
Survivorship specific quality of life
Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Health literacy
Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Referrals to municipality rehabilitation
Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Mette Schaufuss Engedal, MSc principal investigator
Rigshospitalet. Department of Hematology. Denmark
Mary Jarden study director
Rigshospitalet. Department of Hematology. Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlloCare in people with Hematological Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mette Schaufuss Engedal, MSc (+45 51896699, mette.schaufuss.engedal@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30) (time frame: 15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)). 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 1 Aug 2025.