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

Rigshospitalet

Status: Enrolling

Conditions: Hematological Diseases

Treatments: Behavioral: AlloCare

Study type: Interventional

Funder types: Other

Identifiers

NCT06281496

Rigshospitalet, Hematology

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: AlloCare

Control Group

No Intervention group

Description:

Patients in the control group will receive usual care