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Completed

NCT Number: NCT04707417

Home Care in 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home care

Other

Advanced home care

Primary outcomes

  1. GRFS

    Time frame: 1 year

    GvHD-free, relapse-free survival

  2. QoL

    Time frame: 6 weeks

    Quality of Life

Secondary outcomes

  1. GvHD

    Time frame: 1 year

    Graft versus host disease

  2. TRM

    Time frame: 1 year

    Transplant related mortality

  3. Infection

    Time frame: 1 year

    Bacteriemia and invasive fungal disease

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2021
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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