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Completed

NCT Number: NCT06277479

Late Effects and HRQoL in Survivors of Allo-HSCT - 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.

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Key information

Conditions

Hematological Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mette Schaufuss Engedal

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Health literacy Questionnaire (HLQ)

    Time frame: may 2024 - august 2024

    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.

  2. Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale

    Time frame: may 2024 - august 2024

    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

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Danish Cancer Society

Registry information

Official study title

Late Effects and Health-Related Quality of Life in Survivors of Allogeneic Hematopoietic - a Cross-sectional Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 26, 2024
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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