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

NCT06281496 | Recruiting

• 1 other identifier: Rigshospitalet, Hematology
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematological Diseases

Keywords

Late effects. Survivorship. Allo-HSCT

Outcome Measures

Primary Outcomes (1)

• Quality of life - summary score measured by European Organisation for Research and Treatment of Cancer QOL questionnaire (EORTC-QOL-C30)

  Between-group changes in Quality of life - from baseline 3 months post treatment with allogenenic stem cell transplantation to postintervention 12 months post treatment with allogeneic stem cell transplantation. EORTC Quality of Life core questionnaire (QLQ-C30). The EORTC QoL Core Questionnaire EORTC QLQ-C30 is a 30-item instrument designed to measure quality of life in all cancer patients. The questionnaire consists of five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health status / QoL scale, and some single items assessing additional symptoms commonly reported by cancer patients

  15 months (baseline 3, post intervention 12 and follow-up 18 month after treatment with allogeneic stem cell transplantation)

Secondary Outcomes (4)

• Survivorship specific quality of life

  15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)

• Health literacy

  15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)

• Referrals to municipality rehabilitation

  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

  15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: AlloCare

Control Group

NO INTERVENTION

Patients in the control group will receive usual care

Interventions

AlloCare BEHAVIORAL

Survivorship supportive care

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Cancer Society: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Mette Schaufuss Engedal, MSc

  Rigshospitalet. Department of Hematology. Denmark

  PRINCIPAL INVESTIGATOR

• Mary Jarden

  Rigshospitalet. Department of Hematology. Denmark

  STUDY DIRECTOR

Central Study Contacts

Mette Schaufuss Engedal, MSc

CONTACT

+45 51896699; mette.schaufuss.engedal@regionh.dk

Mary Jarden

CONTACT

+4535454368; mary.jarden@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist, Ph.d student

Model Details: One site, two arm randomized controlled trial

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)