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Hematologic NeoplasmHematoCareNCT07579065

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

A study testing Survivorship Care (SC) Plan in people with Hematologic Neoplasm and Hematopoietic Stem Cell Transplantation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Survivorship Care (SC) Plan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteItaly
Study dates
Jun 2026to Jan 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Barbara Bressi contact

barbara.bressi@ausl.re.it

Stefania Costi contact

stefania.costi2@ausl.re.it

Italy1 site, 1 recruiting

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

    Reggio Emilia

    Barbara Bressi

    Recruiting

Other trials in Italy

About this study

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

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

Read the 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).

Being tested
Survivorship Care (SC) Plan
Keywords
Hematologic Malignancies, Survivorship Care, Quality of Life, Caregiver Burden, Unmet Needs, Feasibility Study, Patient Reported Outcome Measures (PROMs)
Medical subject headings
Hematologic Neoplasms, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survivorship Care (SC) PlanOther

    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.

Study groups in NCT07579065
Study groupRoleWhat they receive
Survivorship Care PlanOtherPatients undergoing haematopoietic stem cell transplantation (HSCT), either autologous or allogeneic.
Receives: Other: Survivorship Care (SC) Plan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention Fraction

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

    Measured: 6 months

Secondary outcomes (7)

  1. Quality of Life assessed by EORTC QLQ-C30

    Quality of life will be assessed using the EORTC QLQ-C30 questionnaire, a 30-item multidimensional instrument including a global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, pain, and nausea/vomiting), and six single items assessing additional symptoms. Higher scores indicate better quality of life for global health status and functional scales, but worse symptom severity for symptom scales. The minimal clinically important difference (MCID) is estimated between 5 and 10 points.

    Measured: baseline, 100days, 6 months

  2. Caregiver Burden assessed by Caregiver Reaction Assessment (CRA)

    Measured via the Caregiver Reaction Assessment (CRA) scale. It consists of 24 item evaluating five domains: impact on schedule, finances, lack of family support, health, and caregiver esteem. Domain scores are calculated as the mean of the corresponding items and range from 1 to 5. Higher scores represent a greater impact on the caregiver's life in each specific domain, except for 'Caregiver Esteem', where higher scores reflect a more positive experience

    Measured: baseline, 100 days, 6 months

  3. Perceived needs of patients

    Perceived needs of patients assessed through Supportive Care Needs Survey - Short Form, 34 items (SCNS-SF34), a validated self-report instrument assessing perceived supportive care needs of adult cancer patients across five domains: psychological, health system and information, physical and daily living, patient care and support, and sexuality.

    Scoring and Interpretation:

    Each item is scored on a 5-point Likert scale ranging from 1 to 5, where:

    1. means 'No need' (satisfied)
    2. means 'No need' (already met) 3, 4, and 5 indicate 'Unmet need' (low, moderate, and high, respectively). For each domain, the raw scores are transformed into a standardized scale from 0 to 100. Higher scores indicate a greater level of unmet needs, meaning that the patient requires more support in that specific area.

    Measured: baseline, 100 days, 6 months

  4. Usability of data collection - Patient Perspective

    This assessment will be conducted from the perspectives of patients using structured questionnaires developed for this study.

    The implementation outcomes of acceptability, appropriates, adoption, and feasibility will be investigated. Specifically, the questionnaire will assess the perceived length of the question battery (burden), potential item redundancy, and the overall relevance and sensitivity of the topics addressed in relation to the post-transplant experience.

    Measured: 6 months

  5. Providers' ability to deliver the SC plan

    Providers' ability to deliver the SC plan will be assessed through a post-intervention questionnaire. This tool will verify the successful delivery of the core components of the SC plan by evaluating the following domains: fidelity, appropriateness, feasibility, and sustainability.

    Measured: 12 months

  6. Quality of Life assessed by EORTC QLQ-HDC29

    Quality of life will be assessed using the disease-specific EORTC QLQ-HDC29 module for patients undergoing high-dose chemotherapy. This instrument includes 29 items divided into six multi-item scales (gastrointestinal side effects, worries/anxiety, impact on family, body image, sexuality, and in-patient issues) and eight single items (skin problems, fever, urinary frequency, bone pain, ability to complete activities, spirituality, fertility, and medication intake). Higher scores indicate greater impairment in quality of life.

    Measured: Baseline, 100 days, 6 months

  7. Usability of Data Collection - Provider Perspective

    This assessment will be conducted from the perspectives of healthcare providers, using structured questionnaires developed for this study. The evaluation will focus on feasibility and appropriateness. The questionnaire will assess whether the data collection process was manageable within standard clinical timeframes and, crucially, whether the tools effectively supported the professional in gathering actionable information to integrate the SC Plan.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07579065
Sponsor's protocol ID
153/2026/SPER/AUSLRE
Acronym
HematoCare
Status last verified
Jun 2026
First submitted
30 Apr 2026
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 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.

    PubMed 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 (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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 39612038

  • 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.

    PubMed 20957426

Questions about this trial

What is this clinical trial studying?

A study testing Survivorship Care (SC) Plan in people with Hematologic Neoplasm and Hematopoietic Stem Cell Transplantation, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Barbara Bressi (barbara.bressi@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention Fraction (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07579065, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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