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Recruiting NCT06281496

AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation

No phase Interventional Hematological Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AlloCare.
Who it may be relevant to
Registry conditions: Hematological Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

A developed multimodal intervention targeting late effects in survivors of allogeneic hematopoietic stem cell transplantation (allo-HSCT) will be evaluated in a two-arm randomized controlled trial with an internal pilot phase.

Detailed description

The study aims to investigate the effect of a stepped care intervention in allo-HSCT survivors on health-related quality of life and late effects.

Method:

This study is designed as a one-site, two-arm prospective randomized controlled trial proceeding an internal pilot phase.

Population/recruitment:

Recruitment, inclusion, and exclusion criteria as described in the eligibility section. Included patients will be randomized and allocated 1:1 to an intervention group or a control group.

Intervention:

a stepped-care multi-modal intervention

Interventions

  • Behavioral AlloCare
    Survivorship supportive care

Primary outcome measures

  • Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30) [Time frame: 15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)]
Secondary outcome measures (4)
  • Survivorship specific quality of life [Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)]
  • Health literacy [Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)]
  • Referrals to municipality rehabilitation [Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)]
  • Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale [Time frame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)]

Eligibility criteria

Inclusion criteria

  • Adult patients (age> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.

Exclusion criteria

  • Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Identifiers

NCT: NCT06281496 · Rigshospitalet, Hematology

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗