AlloCare

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hematological Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

One site, two arm randomized controlled trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

The intervention is a stepped-care multi-modal intervention and consists of 4 steps, including screening for vulnerability, digital health support and education. Individual consultations based on PRO data (HM-PRO) and multidisciplinary late effects management based on PRO assessment. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians.

Group Type EXPERIMENTAL

Intervention Type BEHAVIORAL

Survivorship supportive care

Control Group

Patients in the control group will receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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AlloCare

Survivorship supportive care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.