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New treatment option for Classical Hodgkin Lymphoma
Official title Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors
ClinicalTrials.gov ID: NCT05934084
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- 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);
You likely can't join if
- 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...
See the full eligibility 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...
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ancona, Ancona, Italy
- Aviano, Aviano, Italy
- Bari, Bari, Italy
- Belluno, Belluno, Italy
- Barletta, Italy
- Bolzano, Italy
- Brescia, Italy
- Brindisi, Italy
- Caltanissetta, Italy
- Catania, Italy
- Como, Italy
- Florence, Italy
- Lecce, Italy
- Legnano, Italy
- Messina, Italy
- Milan, Italy
- Modena, Italy
- Novara, Italy
- Padova, Italy
- Pagani, Italy
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ancona, Ancona, Italy; Aviano, Aviano, Italy; Bari, Bari, Italy; Belluno, Belluno, Italy; Barletta, Italy; Bolzano, Italy and 27 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.