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NCT Number: NCT07579065

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Reggio Emilia, Italy

Location status: Recruiting

Location contact

Barbara Bressi

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Retention Fraction

    Time frame: 6 months

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

Secondary outcomes

  1. Quality of Life assessed by EORTC QLQ-C30

    Time frame: baseline, 100days, 6 months

    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.

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

    Time frame: baseline, 100 days, 6 months

    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

  3. Perceived needs of patients

    Time frame: baseline, 100 days, 6 months

    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:

    • means 'No need' (satisfied)
    • 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.
  4. Usability of data collection - Patient Perspective

    Time frame: 6 months

    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.

  5. Providers' ability to deliver the SC plan

    Time frame: 12 months

    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.

  6. Quality of Life assessed by EORTC QLQ-HDC29

    Time frame: Baseline, 100 days, 6 months

    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.

  7. Usability of Data Collection - Provider Perspective

    Time frame: 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Bressi

CONTACT

[email protected]

Stefania Costi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

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

Acronym: HematoCare

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 11, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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