Hematological DiseasesNCT06277479
Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study
An observational study of Hematological Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Diseases
- How many people
- 1,262 participants
- Where
- 1 siteDenmark
- Study dates
- 25 May 2024to 1 Dec 2025
- Phase
- Observational
- 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
Study population: All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible
Who may be able to join
- All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible
Who cannot join
- Patient unable to read and understand danish are excluded from study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Late Effects and Health-Related Quality of Life in Survivors of Allogeneic Hematopoietic - a Cross-sectional Study
The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.
Read the detailed description
Objective
The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.
Method
An observational, descriptive, cross-sectional study using clinical data and self-reported questionnaires to assess the occurrence of comorbidities and self-reported late effects in survivors treated with allo-HSCT in Denmark between 1970 and 2024.
Study population
All survivors treated for malignant or non-malignant hematological disease with allo-HCST at the age of 18-79 years from 1970-2024 in Denmark are eligible (n=1.436).
Endpoints
- Self-reported survivorship specific HRQoL measured by EORTC-QOL- Survivorship 100.
- Degree of health literacy measured by the Health Literacy Questionnaire (HLQ).
- Occurrence or degree of Chronic Graft Versus Host Disease measured by modified Lee Chronic Graft versus host disease Symptom Scale.
- Conditions
- Hematological Diseases
- 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.
| Study group | Role | What they receive |
|---|---|---|
| AlloHSCT Rigshospitalet | All patients treated at Department of Hematology, Rigshospitalet | |
| AlloHSCT Skejby | All patients treated at Department of Hematology, Skejby |
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)
The QLQ-SURV100 is based on the EORTC Quality of Life core questionnaire (QLQ-C30). Applicable to disease-free cancer 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: may 2024 - August 2024
Secondary outcomes (2)
Health literacy Questionnaire (HLQ)
The HLQ consists of 9 scales representing 9 dimensions of health literacy. Each HLQ scale has 4-6 items. The HLQ does not provide one overall summative score. The 9 scale scores will reflect a person's strengths and needs in the different dimensions of health literacy.Higher score reflect a higher degree of health literacy.
- Feeling understood and supported by healthcare providers
- Having sufficient information to manage my health
- Actively managing my health
- Social support for health
- Appraisal of health information
- Ability to actively engage with healthcare providers
- Navigating the healthcare system
- Ability to find good health information
- Understand health information well enough to know what to do.
Measured: may 2024 - august 2024
Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
The Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale is a 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). 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". Score range from 0 to 100, with a higher score indicating worse symptoms
Measured: may 2024 - august 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start25 May 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,262 participants (actual)
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, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277479
- Sponsor's protocol ID
- Rigshospitalet. Hematology
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Effects and Health-Related Quality of Life in Survivors of Allogeneic Hematopoietic - a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06277479
- Acronym / sponsor ID
- Rigshospitalet. Hematology
- Conditions
- Hematological Diseases
- Keywords
- Late effects. Survivorship. Allo-HSCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,262 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- 25 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 26 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.
The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.
Detailed description
Objective
The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.
Method
An observational, descriptive, cross-sectional study using clinical data and self-reported questionnaires to assess the occurrence of comorbidities and self-reported late effects in survivors treated with allo-HSCT in Denmark between 1970 and 2024.
Study population
All survivors treated for malignant or non-malignant hematological disease with allo-HCST at the age of 18-79 years from 1970-2024 in Denmark are eligible (n=1.436).
Endpoints
- Self-reported survivorship specific HRQoL measured by EORTC-QOL- Survivorship 100.
- Degree of health literacy measured by the Health Literacy Questionnaire (HLQ).
- Occurrence or degree of Chronic Graft Versus Host Disease measured by modified Lee Chronic Graft versus host disease Symptom Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlloHSCT Rigshospitalet | – | –All patients treated at Department of Hematology, Rigshospitalet |
| AlloHSCT Skejby | – | –All patients treated at Department of Hematology, Skejby |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible
Key inclusion criteria (1 listed)
- All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible
Key exclusion criteria (1 listed)
- Patient unable to read and understand danish are excluded from study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)
Time frame: may 2024 - August 2024
The QLQ-SURV100 is based on the EORTC Quality of Life core questionnaire (QLQ-C30). Applicable to disease-free cancer 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.
2 secondary outcomes
Health literacy Questionnaire (HLQ)
Time frame: may 2024 - august 2024
Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
Time frame: may 2024 - august 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
Mette Schaufuss Engedal, MSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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: finished, as of the sponsor's last update on 18 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100) (time frame: may 2024 - August 2024). 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 18 Dec 2025.