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

Official title

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

Overview

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

Detailed description

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).

Interventions

• Other 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

Primary outcome measures

• Retention Fraction [Time frame: 6 months]

Secondary outcome measures (7)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

Italy · 1 center

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

Publications

• Spellman SR, Xu K, Oloyede T, Ahn KW, Akhtar O, Bolon YT, Broglie L, Bloomquist J, Bupp C, Chen M, Devine SM, El-Jurdi N, Hamadani M, Hengen M, Huppler AH, Jaglowski S, Kuxhausen M, Lee SJ, Moskop A, Page KM, Pasquini MC, Perez W, Phelan R, Rizzo D, Saber W, Stefanski HE, Steinert P, Tuschl E, Visotcky A, Vogel R, Auletta JJ, Shaw BE, Allbee-Johnson M. Current Activity Trends and Outcomes in Hemat PMID 40398621
• 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

Identifiers

NCT: NCT07579065 · 153/2026/SPER/AUSLRE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗