Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

Sponsor

Oslo University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04707417

Collaborator

(none)

130

Enrollment

Location

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stem Cell Transplant Complications Quality of Life GVH - Graft Versus Host Reaction	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 Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Outcome Measures

Primary Outcome Measures

GRFS [1 year]
GvHD-free, relapse-free survival
QoL [6 weeks]
Quality of Life

Secondary Outcome Measures

GvHD [1 year]
Graft versus host disease
TRM [1 year]
Transplant related mortality
Infection [1 year]
Bacteriemia and invasive fungal disease

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Haematology, Division of Cancer Medicine, Oslo University Hospital	Oslo		Norway	0424

Sponsors and Collaborators

Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anders E. L. Myhre, Consultant Haematologist, Oslo University Hospital

ClinicalTrials.gov Identifier:

NCT04707417

Other Study ID Numbers:

212733

First Posted:

Jan 13, 2021

Last Update Posted:

Jan 13, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 13, 2021