Clinical trial NCT06281496: AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
Official title: AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematological Diseases
Keywords: Late effects. Survivorship. Allo-HSCT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
First posted: 2024-02-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One site, two arm randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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:

a stepped-care multi-modal intervention

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Quality of life compared to control group - measured by European Organisation for Research and Treatment of Cancer QOL questionnaire
timeFrame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Secondary outcomes:
measure: Survivorship specific quality of life
timeFrame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
measure: Health literacy
timeFrame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
measure: Referrals to municipality rehabilitation
timeFrame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
measure: Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale
timeFrame: 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet. Department of Hematology. Denmark
name: Mette Schaufuss Engedal, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet. Department of Hematology. Denmark
name: Mary Jarden
role: STUDY_DIRECTOR
References: