Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorFondazione Italiana Linfomi - ETS

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lifestyles Implemented-Survivorship Care Plan (LS-SCP)

    Behavioral

    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.

Treatment groups

552 Participants
are divided into 2 treatment groups
Group A: Control Arm (C)No intervention 0 interventions
Group B: Experimental Arm (E)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Overall survival (OS)

Overall survival, the percentage of patients alive of the cohort

Time frame
From study start up to 30 months
4

Frequencies of chronic fatigue (FAS);

The number of times chronic fatigue is recorded in the cohort of patients

Time frame
From study start up to 30 months

Other outcomes

Sponsors and contacts

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