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

May 6, 2026 updated by: Azienda USL Reggio Emilia - IRCCS

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Reggio Emilia, Italy
        • Research and EBP Unit, Azienda USL-IRCCS di Reggio Emilia
        • Principal Investigator:
          • Barbara Bressi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Survivorship Care Plan
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Fraction
Time Frame: 6 months
The percentage of enrolled patients who complete at least 70% of the scheduled assessments
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, 100days, 6 months
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
baseline, 100 days, 6 months
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:

  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.
baseline, 100 days, 6 months
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.
6 months
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.
12 months
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.
Baseline, 100 days, 6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Reggio Emilia - IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 153/2026/SPER/AUSLRE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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