Healthy Lifestyle Plan for Lymphoma Survivors

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 clinical trial evaluates the effectiveness of a Survivorship Care Plan (SCP) that includes lifestyle modifications, nutritional guidance, and physical activity for long-term lymphoma survivors. Participants will be randomly assigned to either the intervention group, which follows the SCP for six months, or a control group that receives standard follow-up care without the SCP. Quality of life will be assessed using validated questionnaires at baseline, 6 months, and 12 months post-randomization. The study aims to determine if the SCP can improve the overall well-being of lymphoma survivors who have been in remission for at least three years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18-50 at initial treatment;
* Diagnosis of classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL) or Primary mediastinal large B-cell lymphoma (PMBCL);
* Patients in Complete Remission (CR) after first-line therapy \[ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, doxorubicin , cyclophosphamide, vincristine, procarbazine and prednisone) or ABVD-BEACOPP Pet-2 guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adapted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL);
* Patients in remission for a minimum 3 years since the last treatment and a maximum of 10 years;
* Cumulative doxorubicin/ adriamycin dose received of at least 200 mg/mq (4 cycles of chemotherapy);
* Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensional speckle strain echocardiography) performed no later than three months prior to enrollment;
* Signature of a written informed consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate voluntarily in the study.

Exclusion Criteria:

* Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix;
* Second line chemotherapy of stem cell transplant;
* Not able to perform physical activity;
* Grade \>/=3 neuropathy;
* Vertebral fractures or stenosis of the vertebral canal; other bone fracture;
* Cardiovascular disease: arrhythmia \>/= grade 2, hypertension \>/ grade 2, left ventricular dysfunction \>/= grade 2 pericardial disease/effusion any grade, myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathy any grade valvular hearth disease \>/= grade 2, right ventricular dysfunction \>/= grade 2;
* Venous thromboembolism or arterial thrombosis during last 6 months;
* Hemorrhage/ bleeding \>/= grade 2 during last 6 months;
* Chronic lymphedema (arms and/ or limbs);
* Rheumatic disease or inflammatory bowel disease in systemic treatment;
* Any pleural effusion;
* If female, the patient is pregnant;
* Unwilling to comply to all required visits and procedures for the duration of study participation

Where it's running

• Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
  Ancona, Ancona, Italy Recruiting
• Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
  Aviano, Aviano, Italy Recruiting
• Istituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
  Bari, Bari, Italy Recruiting
• Ospedale S. Martino - UOC Oncologia
  Belluno, Belluno, Italy Recruiting
• Ospedale "Monsignor Raffaele Dimiccoli" - Ematologia
  Barletta, Italy Recruiting
• Ospedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
  Bolzano, Italy Recruiting

Study contacts

• Principal investigator: Carla Minoia, MD — Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
• Study coordinator: Uffici Studi FIL
• Email: startup@filinf.it
• Phone: 0599769918

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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.