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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Survivorship Care Plan | Other | Patients undergoing haematopoietic stem cell transplantation (HSCT), either autologous or allogeneic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Retention Fraction | The percentage of enrolled patients who complete at least 70% of the scheduled assessments | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Bressi | Contact | barbara.bressi@ausl.re.it | ||
| Stefania Costi | Contact | stefania.costi2@ausl.re.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research and EBP Unit, Azienda USL-IRCCS di Reggio Emilia | Reggio Emilia | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40398621 | Background | 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. | |
| 26844291 |
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| baseline, 100days, 6 months |
| 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 | baseline, 100 days, 6 months |
| 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:
| baseline, 100 days, 6 months |
| 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. | 6 months |
| 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. | 12 months |
| 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. | Baseline, 100 days, 6 months |
| 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. | 6 months |
| 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. |
| 23306934 | 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. |
| 20187072 | 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. |
| 27590102 | 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. |
| 29253069 | 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. |
| 37713972 | 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. |
| 39612038 | 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. |
| 20957426 | 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. |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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