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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematological Diseases
• Intervention / Treatment: Behavioral: AlloCare

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mette Schaufuss Engedal, MSc; Phone Number: +45 51896699; Email: mette.schaufuss.engedal@regionh.dk
• Study Contact Backup: Name: Mary Jarden; Phone Number: +4535454368; Email: mary.jarden@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Recruiting
    • Rigshospitalet
    • Contact: Mary Jarden, Professor; Email: mary.jarden@regionh.dk
    • Contact: Mette Schaufuss Engedal, MSc; Phone Number: +45 35450978; Email: mette.schaufuss.engedal@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Patients in the control group will receive usual care
Experimental: 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.	Behavioral: AlloCare; Survivorship supportive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health literacy	The survey encompasses nine separate scales exploring 9 different domains of health literacy. The following health literacy domains have been chosen; Scale 1: Feeling understood and supported by health care providers. Scale 3: Actively managing my health. Scale 8: Ability to find good health information and finally Scale 9: Understanding health information well enough to know what to do. The scales can be used individually as no summary score of total health literacy can be measured.	15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Referrals to municipality rehabilitation	Municipal rehabilitation adresses both physical rehabilitation as well as psychosocial and work related problems based on disease and cancer treatment.	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	Validated questionnaire to measure degree of Graft Versus Host disease. The scale contains 28 items grouped in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological), and a 7 day recall period. Patients report how "bothered" they feel about each symptom over the previous 7 days using a five-point Likert scale from "not at all" to "extremely". range from 0 to 100, with a higher score indicating worse symptoms	15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Survivorship specific quality of life	EORTC-QOL-SURV100, Quality of life questionnaire applicable to cancerfree survivors. It consists of 100 questions divided over thirteen functional scales (i.e. Physical; Role ; Emotional; and Cognitive functioning; Body image; Symptom awareness; Positive health behavior change; Positive life outlook; Positive impact on behavior towards others; Positive social functioning; Work; Sexual functioning; Global health status), nine symptom scales (i.e. Social isolation; Fatigue; Pain; Sleep problems; Health distress; Negative health outlook; Social interference; Sexual problems), one Symptom checklist assessing chronic side effects of cancer treatments, and twelve single items. Score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QL represents a high QL, but a high score for a symptom item represents a high level of symptomatology.	15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Danish Cancer Society
• Investigators: Principal Investigator: Mette Schaufuss Engedal, MSc, Rigshospitalet. Department of Hematology. Denmark; Study Director: Mary Jarden, Rigshospitalet. Department of Hematology. Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Late effects. Survivorship. Allo-HSCT
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: Rigshospitalet, Hematology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No