NCT04707417

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

January 12, 2021

Last Update Submit

November 13, 2023

Conditions

Stem Cell Transplant ComplicationsQuality of LifeGVH - Graft Versus Host Reaction

Outcome Measures

Primary Outcomes (2)

  • GRFS

    GvHD-free, relapse-free survival

    1 year

  • QoL

    Quality of Life

    6 weeks

Secondary Outcomes (3)

  • GvHD

    1 year

  • TRM

    1 year

  • Infection

    1 year

Interventions

Home careOTHER

Advanced home care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients planned for treatment with allogeneic stem cell transplantation

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled infection or other medical condtion unsuitable for out patient care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Oslo, 0424, Norway

Location

MeSH Terms

Interventions

Home Care Services

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesNursing Services

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Haematologist

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 13, 2021

Study Start

February 1, 2022

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)