Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

Quality of Life Clinical Trial

Official title:

Impact of Home Care for Recipients of Allogeneic Haematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04707417
• Other study ID #: 212733
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Home care
Advanced home care

Locations

Country	Name	City	State
Norway	Department of Haematology, Division of Cancer Medicine, Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GRFS	GvHD-free, relapse-free survival	1 year
Primary	QoL	Quality of Life	6 weeks
Secondary	GvHD	Graft versus host disease	1 year
Secondary	TRM	Transplant related mortality	1 year
Secondary	Infection	Bacteriemia and invasive fungal disease	1 year