HematoCare: Feasibility of a Survivorship Care Plan for Hematologic Cancer Patients Undergoing HSCT

Официальное название

Survivorship Care in Patients With Hematologic Cancer Undergoing HSCT: A Feasibility Study on Quality of Life, Unmet Needs, and Caregivers Burden

Обзор

This is a feasibility study to implement a Survivorship Care (SC) Plan for patients with hematologic cancer undergoing hematopoietic stem cell transplantation (HSCT). The study evaluates if the intervention is feasible within the Italian national health system, focusing on retention rates, quality of life, unmet needs and caregiver burden

Подробное описание

Haematopoietic stem cell transplantation (HSCT), whether autologous or allogeneic, is a cornerstone of modern haematological oncology, with the volume of procedures steadily increasing both globally and nationally. The rise in survival rates beyond 12 months has made the management of long-term survivorship an emerging clinical and epidemiological priority.Despite its curative efficacy, HSCT and associated cytotoxic treatments lead to late and chronic complications that cause significant functional, social and psychological impairment. Factors such as recurrent infections, prolonged isolation and reduced mobility have a negative impact on quality of life, functional capacity and fatigue levels. At the same time, informal carers (family members or friends) bear a significant caregiving and emotional burden that threatens their overall well-being.An integrated assessment of the needs of both the patient and the carer as the core unit of care is essential to provide adequate support. Although Survivorship Care (SC) is recommended for the systematic management of late effects, its implementation in structured and sustainable models within the National Health Service remains complex.This prospective, single-center, single-arm study follows patients from hospital discharge to 6 months post-transplant. The intervention consists of a personalized SC Plan including treatment summaries, follow-up recommendations, and referrals to supportive services. Data on feasibility, quality of life (EORTC QLQ-C30), unmet needs (SCNS-SF34), and caregiver burden (CRA) will be collected at T0 (baseline), T1 (100 days), and T2 (6 months).

Вмешательства

• Другое Survivorship Care (SC) Plan
  The SC plan is tailored to the patient's needs and accounts for the appropriate treatment summary, follow-up recommendations and advice addressed to health promotion and to the management of symptoms and treatments' side-effects. Upon discharge, patients will be followed up by a care coordinator (oncology/basic nurse, physical therapist, or occupational therapist) who will assess their QoL and perceived needs. Based on these results, the SC plan will be integrated with appropriate referral to ed

Первичные конечные точки

• Retention Fraction [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Quality of Life assessed by EORTC QLQ-C30 [Срок оценки: baseline, 100days, 6 months]
• Caregiver Burden assessed by Caregiver Reaction Assessment (CRA) [Срок оценки: baseline, 100 days, 6 months]
• Perceived needs of patients [Срок оценки: baseline, 100 days, 6 months]
• Usability of data collection - Patient Perspective [Срок оценки: 6 months]
• Providers' ability to deliver the SC plan [Срок оценки: 12 months]
• Quality of Life assessed by EORTC QLQ-HDC29 [Срок оценки: Baseline, 100 days, 6 months]
• Usability of Data Collection - Provider Perspective [Срок оценки: 6 months]

Критерии участия

Критерии включения

• Patients with hematologic cancer candidates for HSCT (autologous or allogeneic) and their informal caregivers
• Able to provide informed consent
• Able to communicate in Italian

Критерии исключения

• Patients or caregivers with comorbidities hindering participation (e.g., significant cognitive limitations)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Research and EBP Unit, Azienda USL-IRCCS di Reggio Emilia — Reggio Emilia

Публикации

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• Gratwohl A, Sureda A, Baldomero H, Gratwohl M, Dreger P, Kroger N, Ljungman P, McGrath E, Mohty M, Nagler A, Rambaldi A, de Elvira CR, Snowden JA, Passweg J, Apperley J, Niederwieser D, Stijnen T, Brand R; Joint Accreditation Committee (JACIE) of the International Society for Cellular Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT) and the European Leukemia Net PMID 26844291
• Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10. PMID 23306934
• Molassiotis A, Wilson B, Blair S, Howe T, Cavet J. Unmet supportive care needs, psychological well-being and quality of life in patients living with multiple myeloma and their partners. Psychooncology. 2011 Jan;20(1):88-97. doi: 10.1002/pon.1710. PMID 20187072
• Shaw BE, Hahn T, Martin PJ, Mitchell SA, Petersdorf EW, Armstrong GT, Shelburne N, Storer BE, Bhatia S. National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Research Methodology and Study Design Working Group Report. Biol Blood Marrow Transplant. 2017 Jan;23(1):10-23. doi: 10.1016/j.bbmt.2016.08.018. Epub 2016 Aug 30. PMID 27590102
• Jordan K, Aapro M, Kaasa S, Ripamonti CI, Scotte F, Strasser F, Young A, Bruera E, Herrstedt J, Keefe D, Laird B, Walsh D, Douillard JY, Cervantes A. European Society for Medical Oncology (ESMO) position paper on supportive and palliative care. Ann Oncol. 2018 Jan 1;29(1):36-43. doi: 10.1093/annonc/mdx757. PMID 29253069
• Contri A, Paltrinieri S, Torreggiani M, Chiara Bassi M, Mazzini E, Guberti M, Campanini I, Ghirotto L, Fugazzaro S, Costi S. Patient-reported outcome measure to implement routine assessment of cancer survivors' unmet needs: An overview of reviews and COSMIN analysis. Cancer Treat Rev. 2023 Nov;120:102622. doi: 10.1016/j.ctrv.2023.102622. Epub 2023 Sep 9. PMID 37713972
• Schiavi M, Costi S, Barbieri I, Ghirotto L, Fugazzaro S, Bressi B, Paltrinieri S, Luminari S, Contri A. Identifying unmet needs in cancer survivorship by linking patient-reported outcome measures to the International Classification of Functioning, Disability and Health. Support Care Cancer. 2024 Nov 29;32(12):835. doi: 10.1007/s00520-024-09019-8. PMID 39612038

Идентификаторы

NCT: NCT07579065 · 153/2026/SPER/AUSLRE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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