Hematological Diseases Clinical Trial
— AlloCareOfficial title:
AlloCare - Support and Management of Late Effects After Allogeneic Hematopoietic Stem Cell Transplantation
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.
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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Danish Cancer Society |
Denmark,
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) |
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