Home Care in Allogeneic Haematopoietic Stem Cell Transplantation

NCT ID: NCT04707417

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-08-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Home care

Advanced home care

Intervention Type OTHER

Eligibility Criteria

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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.

* Uncontrolled infection or other medical condtion unsuitable for out patient care
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anders E. L. Myhre

Consultant Haematologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Haematology, Division of Cancer Medicine, Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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212733

Identifier Type: -

Identifier Source: org_study_id

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