Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change on Extracellular vesicles number by ultracentrifugation with sucrose cushion |
The collected extracellular vesicles will be quantified by Nanoparticle tracking analysis (Nanosight Ltd.), and data will be measured in particles per milliliter (mL). NTA measures Brownian movements on a particle-by-particle basis tracking movements by image analysis. Additionally, miR21-5p - a brain related microRNA - will be measured to ascertain for the extracellular vesicle's origin. The latter will be achieved by isothermal DNA amplification method, and data will be measured by luminescence (in RLU - relative light unit). |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Primary |
Change on anxiety, depression and stress (Depression Anxiety Stress Scales, DASS21) |
This self-report instrument assess the depressive, anxiety and stress symptoms in a 4-points likert scale, from 0 to 3, with higher values representing higher depression, anxiety and stress symptoms |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Cancer antigen (CA 15-3) |
This indicator assess CA 15-3 (units/mL) using an immunoassay analyzer |
T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Prostate-specific antigen (PSA) |
This indicator assess PSA (ng/mL) using an immunoassay analyzer |
T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Carcinoembryonic Antigen assays (CEA) |
This indicator assess CEA (ng/mL) using an immunoassay analyzer |
T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Adrenocorticotropic Hormone (ACTH) |
This indicator assess ACTH (pg/mL) using an immunoassay analyzer |
T0-before intervention;T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Transcript inflammatory response genes (IL-1, IL-6, IL-8, IL-10, IFN? and TNF) |
These indicators assess inflammatory response genes in plasma by Quantitative RT-PCR assays of the same individuals using TaqMan™ Gene Expression Assays |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Analytic biomarkers (Erythrocytes number) |
This indicator assess erythrocytes number (million/mm3) from blood samples(Sysmex XN) |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Analytic biomarkers (PCR number) |
This indicator assess PCR (mg/L) from blood samples |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Analytic biomarkers (telomerase activity) |
This indicator assess telomerase activity (units) from blood samples |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Analytic biomarkers (hemoglobin glycosylated (HPLC)) |
This indicator assess HPLC (mmol/mol) from blood samples |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Global distress (Clinical Outcome Routine Evaluation - Outcome Measure, CORE-OM) |
This self-report measure assesses global distress in four domains: subjective well-being, symptoms, social/life functioning, risk to self and others, rated in 5-points likert scale from never to always. Higher scores meaning higher psychological suffering |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on quality of life (Functional Assessment of Cancer Therapy, FACT) |
These self-report instrument assess perceived quality of life related to the cancer, in a 5-points likert scale, from 0 to 4, with higher value indicated higher quality of life |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on quality of life (Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale, FACIT-SP) |
These self-report instruments assess perceived spiritually related to the cancer in a 5-points likert scale, from 0 to 4, with higher value indicated higher well-being |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on fear of cancer recurrence (Fear of Cancer Recurrence, FCR-7) |
This self-report instrument assess the fear of cancer recurrence, rated in a 5-points likert scale, with higher values indicated higher fear of recurrence |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on satisfaction perceived social support (ESSS) |
This self-report instrument assess the perceived level of social support, rated in a 5-points likert scale, with higher values meaning higher social support |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on emotional regulation processes (Emotion Regulation Questionnaire, ERQ, emotion suppression subscale) |
This self-report measure assess the emotion regulation processes rated in a 7-points likert scale, with higher values representing higher emotional suppression |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on impact of events (Impact of Event Scale - Revised, IES-R) |
This self-report measure assess the impact of significant events, rated in a 5-points likert scale, with higher scores meaning higher negative impact of the event |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on Mindfulness Attention and Awareness (Mindfulness Attention and Awareness Scale, MAAS) |
This self-report measure assess the mindfulness and awareness skills, rated in a 6-points likert scale with higher scores indicating higher attention and awareness |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on self-compassion skills (Self-Compassion Scale - Short Form, SHORT FORM) |
This self-report measure assess the self-compassion skills, rated in 5-points likert scale, with higher scores indicating higher self-compassion |
T0-before intervention; T1-8 weeks after T0; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change Interview (Elliot, 1999) |
This interview assesses the psycho-therapeutic changes perceived by participants after psychological intervention. The interview questions explore the changes that a person has noticed since therapy began, what the person attributes these changes to, and helpful and unhelpful aspects of therapy, in a qualitative way. In addition, the participants identified therapeutic changes as result of the therapy and are asked to rate these changes in three scales: expected change (1: change totally expected; 5: totally unexpected); change without therapy (1: the change would not have happened; 5: change would happen for sure); and the value of the change (1: nothing important; 5: extremely important). |
T2-24 weeks after T0 |
|
Secondary |
Change on smoking dependency (Fagestrom Test) |
This instrument assesses nicotine dependency with 6 items (rated from 0 to 2 or 3). The total score range is 1-10, with higher values meaning higher nicotine dependency |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
|
Secondary |
Change on physical activity (IPAQ,The International Physical Activity Questionnaire) |
This instrument assesses physical activity in 7 items, with higher scores meaning higher level of physical activity |
T0-before intervention; T2-24 weeks after T0; T3-52 weeks after T0 |
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