An interventional study of Survivorship Care (SC) Plan in Hematologic Neoplasm, Hematopoietic Stem Cell Transplantation and Survivorship, sponsored by Azienda USL Reggio Emilia - IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Azienda USL Reggio Emilia - IRCCS · Not applicable, Interventional, and Supportive care
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).
1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.
This study's planned enrollment of 40 is below the median of 46 across 1,044 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing haematopoietic stem cell transplantation (HSCT), either autologous or allogeneic.
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 educational resources, services, and/or sing-post to facilities available in the hospital and/or community.
Retention Fraction
The percentage of enrolled patients who complete at least 70% of the scheduled assessments
Time frame: 6 months
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.
Time frame: 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
Time frame: 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: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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Azienda USL Reggio Emilia - IRCCS