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).
All patients will be assessed by validated questionnaires \[EORTC QLQ-C30 (Quality of Life Questionnaire), SF12 (12-item Short Form Survey), MEDI-LITE (Mediterranean Literature questionnaire), CFSS (Chronic Fatigue Syndrome Self assessment), FAS (Fatigue Assessment Scale), Hospital Anxiety and Depression Scale (HAD-S)\] and clinical assessment performed at baseline, at 6 and 12 months from the randomization. Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity) for 6 months. A bi-monthly automatic call to assess the compliance at the experimental arm (Lifestyles implemented-Survivorship Care Plan (LS-SCP)) will be performed. Patients in the control arm will not receive any Survivorship Care Plan (SCP) or intervention and will be followed-up according to the best clinical practice, with questionnaires self-administration at 6 and 12 months from randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
552
Patients in the experimental arm will follow the planned intervention (Survivorship Care Plan (SCP), nutritional plan, physical activity) for 6 months. A bi-monthly automatic call to assess the compliance at the experimental arm (LS-SCP, Lifestyles implemented-Survivorship Care Plan) will be performed.
Global quality of life
The endpoint will be assessed by the European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) that will be submitted to patients. The EORTC QLQ-C30 consists of 30 items including five functioning scales (physical functioning, social functioning, role functioning, emotional functioning and cognitive functioning), nine symptom scales (fatigue, pain, nausea-vomiting, dyspnoea, sleep disturbances, appetite loss, diarrhoea, constipation and financial difficulties), and a global health status or quality of life (QOL) scale. On the 100-point metric, high scores for functioning scales and the global health status, or QOL, scale indicate high HR (health-related) QOL, while high scores on the symptom scales indicate a high symptom burden.
Time frame: From study start up to 30 months
Impact of health on an individual's everyday life
The endpoint will be assessed by the 12-Item Short Form Survey (SF-12) which will be submitted to patients. Survey scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame: From study start up to 30 months
Changes in psychosocial well-being
The endpoint will be assessed by Hospital Anxiety and Depression Scale (HAD-S) questionnaire which will be submitted to patients. The HAD-S questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Time frame: From study start up to 30 months
Overall survival (OS)
Overall survival, the percentage of patients alive of the cohort
Time frame: From study start up to 30 months
Frequencies of chronic fatigue (FAS);
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Ancona - AOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Ancona, Italy
RECRUITINGAviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Aviano, Italy
RECRUITINGIstituto Tumori Bari Giovanni Paolo II, U.O. di Ematologia e Terapia Cellulare
Bari, Bari, Italy
RECRUITINGOspedale S. Martino - UOC Oncologia
Belluno, Belluno, Italy
NOT_YET_RECRUITINGOspedale "Monsignor Raffaele Dimiccoli" - Ematologia
Barletta, Italy
RECRUITINGOspedale Centrale di Bolzano - Divisione di Ematologia e T.M.O.
Bolzano, Italy
RECRUITINGASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
RECRUITINGOspedale Antonio Perrino - U.O. Ematologia e Trapianti di Midollo
Brindisi, Italy
RECRUITINGPO Sant'Elia ASP Caltanisetta - UOC Ematologia
Caltanissetta, Italy
NOT_YET_RECRUITINGArnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia
Catania, Italy
RECRUITING...and 30 more locations
The number of times chronic fatigue is recorded in the cohort of patients
Time frame: From study start up to 30 months
Cognitive function
The endpoint will be assessed by Cognitive Functioning Self-Assessment Scale (CFSS) questionnaire which will be submitted to patients. The Cognitive Functioning Self-Assessment Scale (CFSS) is a questionnaire designed for the self-reporting of cognitive functioning. Its 18 items cover cognitive domains such as attention, memory and spatial-temporal orientation. Each item describes an activity of daily life in which these domains are involved. Participants answer each item on a 5-point frequency scale, referring to the past 12 months. The tool provides an overall score, calculated as the mean of the scores on individual items, where higher values indicate a worse self-perception regarding cognitive functioning.
Time frame: From study start up to 30 months
Metabolic outcomes -BMI
Body Mass Index (BMI) will be evaluated for every patient. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: From study start up to 30 months
Metabolic outcomes - diabetes
Number of patients of the cohort with diabetes
Time frame: From study start up to 30 months
Frequency cardiovascular disease
The number of times cardiovascular disease is observed in the cohort of patients
Time frame: From study start up to 30 months
Compliance to screening for secondary cancers and vaccination
The number of times patients undergo screening and prevention for secondary cancers
Time frame: From study start up to 30 months
Frequency others comorbidity
The number of times others comorbidities are observed in the cohort of patients
Time frame: From study start up to 30 months
Adherence to healthy lifestyles - healthy diet
The endpoint will be assessed by MEDI-LITE (Mediterranean Literature) questionnaire that will be submitted to patients. Adherence to the Mediterranean diet assessed through the Medi-Lite score was found to be associated with abdominal obesity. The final score, obtained by summing these values, varies from 0 (low adherence) to 18 (high adherence).
Time frame: From study start up to 30 months
Adherence to healthy lifestyles - Physical Activity
The endpoint will be assessed by IPAQ (International Physical Activity Questionnaire) that will be submitted to patients. This questionnaire measures the type and amount of physical activity the patient normally does. The questions refer to activity during the past 7 days at work, getting from place to place, and during leisure time. For the purpose of the questionnaire: one minute per week (MET) is what a patient consumes at rest. Therefore, 2 METS is twice what a patient spends at rest. To obtain a continuous variable score from the IPAQ (MET minutes per week), we will consider walking as 3.3 METS, moderate physical activity as 4 METS, and vigorous physical activity as 8 METS.
Time frame: From study start up to 30 months
Measure of hand grip muscle strength
This end point will be measured through the use of the hand-grip dynamometer
Time frame: From study start up to 30 months
Frequencies of negative Life-Style factors
Number of negative Life-Style factors associated with cardiotoxicity and metabolic syndrome.
Time frame: From study start up to 30 months
Frequency of compliance between planned and effective follow-up via LS-SCP.
Number of times the plan prescribed by the LS-SCP is adhered to correctly in the cohort of patients
Time frame: From study start up to 30 months