Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

Completed

• Conditions: GVH - Graft Versus Host Reaction; Quality of Life; Stem Cell Transplant Complications

• Registration Number: NCT04707417
• Lead Sponsor: Oslo University Hospital

Brief Summary

Mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation

Detailed Description

Study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-HSCT). The main objective is to investigate the impact of home care on transplant specific variables and quality of life (QoL). The main hypothesis is that home care patients will home care patients will have significantly better measured QoL than patients receiving in-hospital care during the first 6 weeks after allo-HSCT. The study will be conducted as part of routine care at the departement of haematology, Oslo University Hospital.

There are qualitative and quantitative aspects to the study. The qualitative part involves focus groups interviews with patients that have been treated with allo-HSCT and have recieved home care and their caregivers.

In the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). Patients in both groups wil answer the questionnaire EORTC QLQ-C30 once weekly for 6 weeks. In addition transplant- and treatment-specific variables will be collected and compares between the groups.

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-13
• Study Start: 2022-02-01
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Consent competency and written informed consent to participation
• Age ≥18
• Understanding and willing to comply with written and oral instructions in Norwegian
• Planned treatment with allo-HSCT
• ECOG performance status 0-2
• Caregiver (age ≥18) present 24 hours a day during the aplastic phase
• Travelling distance from residence to the hospital must be less than one hour.

Exclusion Criteria

• Not meeting inclusion criteria
• Uncontrolled infection or other medical condtion unsuitable for out patient care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GRFS	1 year	GvHD-free, relapse-free survival
QoL	6 weeks	Quality of Life

Secondary Outcome Measures

Name	Time	Method
GvHD	1 year	Graft versus host disease
Infection	1 year	Bacteriemia and invasive fungal disease
TRM	1 year	Transplant related mortality

Trial Locations

Locations (1)

Department of Haematology, Division of Cancer Medicine, Oslo University Hospital; 🇳🇴 Oslo, Norway