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NCT Number: NCT06506396

Rehabilitation Needs for Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy

Hematopoietic Stem Cell Transplantation (HSCT) and CAR T-cell therapy are effective treatments for blood cancers, extending patients lives. However, these treatments can cause side effects like muscle weakness and fatigue. Recent findings suggest these issues can significantly affect patient quality of life during CAR T-cell therapy.

Patients undergoing HSCT and CAR T-cell therapy often face frequent infections and strong immune responses, requiring long periods of rest. This worsens their physical condition and impacts their quality of life, muscle strength, and fatigue levels. Minimizing these side effects is crucial to improve the well-being of patients undergoing these advanced treatments.

This study aims to assess the physical abilities (main goal) of patients preparing for HSCT or CAR T-cell therapy. It also aims to examine their quality of life and describe the symptoms and complications they may experience. The results will help identify rehabilitation needs for these patients.

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Key information

Conditions

Stem Cell Transplantation Behavior CAR T-cell Therapy Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immunotherapy Motor Activity Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is a prospective observational study following STROBE guidelines for observational studies in epidemiology. The study will take place at the Azienda USL-IRCCS di Reggio Emilia, Northern Italy.

Participants will include adults with blood cancer scheduled for HSCT or CAR T-cell therapy. They must be able to understand and speak Italian and make an informed decision to participate in the study.

Patients will be identified at the Hematology Unit of Azienda USL-IRCCS di Reggio Emilia. Medical records will be reviewed to confirm eligibility. Eligible patients will receive detailed information about the study and can decide to participate by signing a consent form.

The study will last 24 months, with an 8-month enrollment period and an 8-month follow-up. Approximately 20 participants will be enrolled based on the number of patients who received HSCT and CAR T-cell therapy in 2023.

Data on participants Sociodemographic and clinical characteristics will be collected at the start of the study. Complications and hospitalizations will be monitored after treatments to understand their impact on patients health.

This study aims to provide valuable insights into the rehabilitation needs of patients undergoing HSCT and CAR T-cell therapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hematologic cancer scheduled to undergo HSCT or CAR T-cell therapy;
  • Age ≥18 years
  • Able to provide informed consent to participate in the study
  • Able to understand and participate in the study
  • Able to understand and communicate in the Italian language

Exclusion criteria

  • Patients who are unable to perform physical tests or have contraindications to movement

Treatment and study plan

Primary outcomes

  1. Physical function

    Time frame: From enrollment up to 8 months later.

    Time up and go (TUG)

  2. Phyical Function

    Time frame: From enrollment up to 8 months later.

    Short Physical Performance Battery (SPPB)

Secondary outcomes

  1. Strength

    Time frame: From enrollment up to 8 months later.

    Handgrip strength test

  2. Quality of life

    Time frame: From enrollment up to 8 months later.

    European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 -QLQ C30. This questionnaire will be administered to assess participants' quality of life. It comprises one global scale, five functional scales, three symptom scales, and six single item scale.All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems

  3. Fatigue

    Time frame: From enrollment up to 8 months later.

    Functional Assesment of Chronic IIlness Therapy-Fatigue.the total score range is 0 to 52. The general population mean score is 43. Lower scores indicate greater fatigue.

  4. Activity of daily living

    Time frame: From enrollment up to 8 months later.

    Duke Activities Score Index (DASI).The DASI is a 12-item questionnaire that asses daily activities in the following domain: productivity, self-care, and leisure time. Total score ranges from 0 to 58.2. Higher scores indicate higher self-perceived functional ability.

  5. Physical activity

    Time frame: From enrollment up to 8 months later.

    International Physical Activities Questionnarie_Short Form (IPAQ-SF).This self-reported questionnaire provides information on the intensity, duration, and frequency of various physical activities, offering valuable insights into participants' overall activity levels. In addition, Metabolic Equivalent of Tasks (METs) are used to classifies the level of patients' physical activity as low (<600 MET), moderate (from 600 to 3000 MET), or high (≥ 3000 MET)

  6. KInesiophobia

    Time frame: From enrollment up to 8 months later.

    Tampa Scale of Kinesiophobia (TSK)The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia

  7. Walking ability

    Time frame: From enrollment up to 8 months later.

    Functional Ambulation Category (FAC).Clinician-completed tick box of 5 broad categories of walking ability, ranges from independent walking outside (score 5) to non-functional walking (score 0).

Other outcomes

  1. Compilcation

    Time frame: From Treatment up to 8 month

    Treatment complication

  2. Legth of stay

    Time frame: From Treatment up to 8 month

    Days of hospitalisation

Study contacts

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

Margherita Schiavi, PhD Candidate

CONTACT

[email protected]

+390522522441

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Collaborators

  • Azienda USL Reggio Emilia - IRCCS

Registry information

Official study title

Outcomes and Rehabilitation Needs of Patients With Hematologic Cancer Candidate for Hematopoietic Stem Cell Transplantation or CAR T-Cell Therapy: a Prospective Observational Study

Acronym: HEMATOneeds

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 17, 2024
Registry last updated
Jul 19, 2024

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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