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

Hematological Diseases Clinical Trial

— AlloCare  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281496
• Other study ID #: Rigshospitalet, Hematology
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: Rigshospitalet, Denmark
• Contact: Mette Schaufuss Engedal, MSc
• Phone: +45 51896699
• Email: mette.schaufuss.engedal[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Diseases
• Hematological Diseases

Intervention

Behavioral:
• AlloCare
Survivorship supportive care

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Cancer Society

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)