Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Stem Cell Transplant Complications; GVH - Graft Versus Host Reaction
• Intervention / Treatment: Other: Home care

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 Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Department of Haematology, Division of Cancer Medicine, Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients planned for treatment with allogeneic stem cell transplantation

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GRFS	GvHD-free, relapse-free survival	1 year
QoL	Quality of Life	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GvHD	Graft versus host disease	1 year
TRM	Transplant related mortality	1 year
Infection	Bacteriemia and invasive fungal disease	1 year

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): August 1, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 212733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No