Clinical trial NCT06277479: Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study
Official title: Late Effects and Health-Related Quality of Life in Survivors of Allogeneic Hematopoietic - a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Diseases
Keywords: Late effects. Survivorship. Allo-HSCT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2024-02-26
Enrollment: 1262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patient unable to read and understand danish are excluded from study participation

Primary outcomes:
measure: EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)
timeFrame: may 2024 - August 2024
Secondary outcomes:
measure: Health literacy Questionnaire (HLQ)
timeFrame: may 2024 - august 2024
measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
timeFrame: may 2024 - august 2024
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Mette Schaufuss Engedal
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mette Schaufuss Engedal, MSc
role: PRINCIPAL_INVESTIGATOR
References: