Tailored exercise program to improve quality of life for adults with hematologic cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter pilot randomized trial will compare a structured, hybrid exercise program against usual care in adults with hematologic malignancies. The program combines supervised home and gym sessions, aerobic and resistance training, balance and stretching, plus behavioral coaching, over 16 weeks. Primary goals are to assess feasibility, including adherence and patient satisfaction, with secondary goals examining safety, patient-reported burden, quality of life, fatigue, and physical fitness. Approximately 75 participants will be randomized 1:1 in this feasibility study to determine whether a larger trial is warranted. Eligible patients are adults 18–75 in remission or near-remission after first-line intensive therapy, recently discharged, with acceptable performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

\*\*Inclusion Criteria:\*\*

1. Patients aged between 18 and 75 years.
2. ECOG Performance Status ≤2.
3. Patients discharged after first-line intensive treatments (Category A), including:

   * Acute myeloid leukemia (AML) in clinical remission following first-line intensive treatment (post-consolidation), within 30 days of hospital discharge, and not candidates for transplantation.
   * Multiple myeloma in clinical remission following first-line treatment with autologous stem cell transplantation, within 30 days of hospital discharge.
   * Lymphoma in clinical remission following first-line intensive treatment (e.g., CODOX-M/IVAC, HYPER-CVAD, DA-EPOCH, CHOP/DHAP, with or without autologous stem cell transplantation consolidation), within 30 days of hospital discharge.
4. Patients receiving or having received first-line treatment in an outpatient setting (Category B), including:

   * Multiple myeloma in complete remission, having completed first-line treatment within the previous 30 days and undergoing maintenance therapy.
   * Lymphoma patients undergoing first-line treatment with at least 12 weeks of therapy remaining.
5. Written informed consent provided.

\*\*Exclusion Criteria:\*\*

1. Undergoing monotherapy with monoclonal antibodies.
2. More than one line of systemic treatment.
3. Estimated life expectancy of less than 6 months.
4. Severe neurological illness.
5. Lack of cardiology clearance or left ventricular ejection fraction below 50%.
6. Unstable fractures or metastases inducing skeletal fragility, as determined by the treating hematologist, or recent femoral or vertebral fracture (within the previous 12 months).
7. Serious active infection.
8. Uncontrolled severe respiratory insufficiency or dependency on oxygen supplementation at rest or during exercise.
9. Uncontrolled severe pain.
10. Any other comorbidity contraindicating physical exercise.
11. Any circumstances preventing adherence to study requirements or the ability to provide informed consent.
12. Logistical barriers preventing adherence to the exercise program, as judged by the treating hematologist (e.g., distance from training locations, work commitments, or family circumstances).
13. Regular engagement in physical activity according to current guidelines during the previous 6 months.

Where it's running

• Fondazione PTV Policlinico Tor Vergata
  Roma, Rm, Italy Recruiting
• Irccs Oncologico Istituto Tumori Giovanni Paolo Ii - Bari - Uo Ematologia
  Bari, Italy Not yet recruiting
• Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia
  Verona, Italy Not yet recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.