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

NCT07579065 | Not Yet Recruiting

• 1 other identifier: 153/2026/SPER/AUSLRE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematologic Neoplasm; Hematopoietic Stem Cell Transplantation; Survivorship; Cancer Survivorship

Keywords

Hematologic Malignancies; Survivorship Care; Quality of Life; Caregiver Burden; Unmet Needs; Feasibility Study; Patient Reported Outcome Measures (PROMs)

Outcome Measures

Primary Outcomes (1)

• Retention Fraction

  The percentage of enrolled patients who complete at least 70% of the scheduled assessments

  6 months

Secondary Outcomes (7)

• Quality of Life assessed by EORTC QLQ-C30

  baseline, 100days, 6 months

• Caregiver Burden assessed by Caregiver Reaction Assessment (CRA)

  baseline, 100 days, 6 months

• Perceived needs of patients

  baseline, 100 days, 6 months

• Usability of data collection - Patient Perspective

  6 months

• Providers' ability to deliver the SC plan

  12 months

Study Arms (1)

Survivorship Care Plan

OTHER

Patients undergoing haematopoietic stem cell transplantation (HSCT), either autologous or allogeneic.

Other: Survivorship Care (SC) Plan

Interventions

Survivorship Care (SC) Plan OTHER

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 educational resources, services, and/or sing-post to facilities available in the hospital and/or community.

Survivorship Care Plan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

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

Reggio Emilia, Italy

Location

Related Publications (9)

• 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 Hematopoietic Cell Transplantation and Cellular Therapy - A Report from the CIBMTR. Transplant Cell Ther. 2025 Aug;31(8):505-532. doi: 10.1016/j.jtct.2025.05.014. Epub 2025 May 19.

  PMID: 40398621 BACKGROUND

• 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 (ELN). Economics and Outcome After Hematopoietic Stem Cell Transplantation: A Retrospective Cohort Study. EBioMedicine. 2015 Nov 19;2(12):2101-9. doi: 10.1016/j.ebiom.2015.11.021. eCollection 2015 Dec.

  PMID: 26844291 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

MeSH Terms

Conditions

Hematologic Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Barbara Bressi

CONTACT

barbara.bressi@ausl.re.it

Stefania Costi

CONTACT

stefania.costi2@ausl.re.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

IT (1)