Late Effects and HRQoL in Survivors of Allo-HSCT - a Cross Sectional Study

NCT06277479 | Completed DMC

• 1 other identifier: Rigshospitalet. Hematology
• Study Type: observational
• Target: 1,262
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematological Diseases

Keywords

Late effects. Survivorship. Allo-HSCT

Outcome Measures

Primary Outcomes (1)

• 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.

  may 2024 - August 2024

Secondary Outcomes (2)

• Health literacy Questionnaire (HLQ)

  may 2024 - august 2024

• Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale

  may 2024 - august 2024

Study Arms (2)

AlloHSCT Rigshospitalet

All patients treated at Department of Hematology, Rigshospitalet

AlloHSCT Skejby

All patients treated at Department of Hematology, Skejby

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Mette Schaufuss Engedal

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Mette Schaufuss Engedal, MSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist, Ph.d student

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: May 25, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

DK (1)