AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
- Conditions
- Hematological Diseases
- Interventions
- Behavioral: AlloCare
- Registration Number
- NCT06281496
- Lead Sponsor
- Rigshospitalet, Denmark
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Adult patients (age> 18 years) treated with myeloablative or non-myeloablative HSCT in outpatient follow-up without recurrent disease are eligible for inclusion.
- Patients with recurrence or subsequent malignancy requiring cancer treatment or lack of access to email and the Internet will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group AlloCare 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.
- Primary Outcome Measures
Name Time Method Changes in Quality of life compared to control group - measured by European Organisation for Research and Treatment of Cancer QOL questionnaire 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation) EORTC Quality of Life core questionnaire (QLQ-C30). The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in all cancer patients. The questionnaire consist 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 a number of single items assessing additional symptoms commonly reported by cancer patients
- Secondary Outcome Measures
Name Time Method Survivorship specific quality of life 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation) 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.Health literacy 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation) 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.
Referrals to municipality rehabilitation 15 months (baseline 3, post intervention 12 and follow up 18 month after treatment with allogeneic stem cell transplantation) Municipal rehabilitation adresses both physical rehabilitation as well as psychosocial and work related problems based on disease and cancer treatment.
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) 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
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark