Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

November 13, 2023 updated by: Anders E. L. Myhre, Oslo University Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 1 year
GvHD-free, relapse-free survival
1 year
QoL
Time Frame: 6 weeks
Quality of Life
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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