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
Patients with hematologic cancer candidates for HSCT (autologous or allogeneic) and their informal caregivers
Able to provide informed consent
Able to communicate in Italian
Patients or caregivers with comorbidities hindering participation (e.g., significant cognitive limitations)
Single group
Survivorship Care (SC) Plan
Other interventionThe 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
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.
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
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.
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.
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