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: Not yet recruiting
• Conditions: Hematological Diseases
• Intervention / Treatment: Behavioral: AlloCare

Detailed Description

The study aims to investigate the effect of a multidisciplinary multimodal intervention in allo-HSCT survivors on survivorship-specific 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:

The intervention is multi-modal and multidisciplinary and consists of two main components including individual consultations based on Patient Reported Outcome Data (HM PRO) and web-based digital health support and education. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians.

Data Collection:

Patient reported Outcome data will be distributed electronically to patients via Redcap and collected at baseline T1, 6 months from allo-HSCT. Post-intervention data collection T2, 12 months from allo-HSCT, and follow-up assessment T3 at 18 months from allo-HSCT.

Primary outcome; Changes in Self-reported HRQoL and burden of late effects measured by EORTC-QOL-SURV100. Secondary outcome: Degree of health literacy measured by the Health Literacy Questionnaire (HLQ). Occurrence of Chronic Graft Versus Host Disease measured by Lee Chronic Graft Versus Host Disease Symptom scale

• 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
    • Rigshospitalet
    • Contact: Mette Schaufuss Engedal, MSc; Phone Number: +45 51896699; Email: mette.schaufuss.engedal@regionh.dk
    • Contact: Mary Jarden, Professor; Email: mary.jarden@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 6 month prior and 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
Experimental: Intervention group; The intervention is multi modal and multidisciplinary and consists of two main components including individual consultations based on PRO data (HM-PRO) and digital health support and education. The multidisciplinary team will consist of nurses, hematologists, physiotherapists, social workers, and dietitians.	Behavioral: AlloCare; Survivorship supportive care
No Intervention: Control Group; Patients in the control group will receive usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)	The QLQ-SURV100 is based on the EORTC Quality of Life core questionnaire (QLQ-C30). Applicable to disease-free cancer 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.	12 months (6, 12, 18 months after treatment with allogeneic stem cell transplantation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months (6, 12, 18 months 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 (Estimated): May 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

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): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

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