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

Hematological Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06277479
• Other study ID #: Rigshospitalet. Hematology
• Status: Enrolling by invitation
• Start date: March 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1600
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Diseases

Locations

Country	Name	City	State
Denmark	Mette Schaufuss Engedal	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	march 2024 - september 2024
Secondary	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.	march 2024 - september 2024
Secondary	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	march 2024 - september 2024