NCT05934084 Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
| NCT ID | NCT05934084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Italiana Linfomi - ETS |
| Condition | Classical Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 552 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 552 participants in total. It began in 2024-02-26 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of healthy LifeStyle implemented Survivorship Care Plan (LS-SCP) in modifying the Quality of Life (QoL) in a population of long-term lymphoma survivors (in remission for a minimum 3 years since the last treatment and a maximum of 10 years).
Eligibility Criteria
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
Contact & Investigator
Carla Minoia, MD
PRINCIPAL INVESTIGATOR
Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia
Frequently Asked Questions
Who can join the NCT05934084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Classical Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05934084 currently recruiting?
Yes, NCT05934084 is actively recruiting participants. Contact the research team at startup@filinf.it for enrollment information.
Where is the NCT05934084 trial being conducted?
This trial is being conducted at Ancona, Italy, Aviano, Italy, Bari, Italy, Belluno, Italy and 11 additional locations.
Who is sponsoring the NCT05934084 clinical trial?
NCT05934084 is sponsored by Fondazione Italiana Linfomi - ETS. The principal investigator is Carla Minoia, MD at Bari, IRCCS Istituto Tumori Giovanni Paolo II - U.O.C Ematologia. The trial plans to enroll 552 participants.