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In this study researchers will examine an influence of three different psychological interventions in the form of mobile application on psycho-neuroendocrine-immune system among breast cancer survivors.
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Background:
Most studies focusing on the effects of psychological interventions on health-related outcomes have relied on self-reports. There is also growing research interest in the effects of such interventions on directly measurable biological processes associated with chronic stress. Neuroendocrine-immune system interactions are fundamental tools through which stress affects the course of cancer. The study will examine effect of three psychological interventions on most frequently studied stress related biomarkers: cortisol, HRV (heart- rate variability), CRP, relative and absolute counts of: B-lymphocytes ,T-lymphocytes, NK-cells, NK-T-like cells, monocytes; cytokine levels. Although current research suggests salutogenic changes in the immune profile of cancer patients as a result of psychological interventions, the results of individual studies are still inconsistent. To get clearer outcomes researchers decided to follow recommendations for researchers in manner that optimizes study design: to recruit very homogenous sample of cancer patients, to continue measurements in 3 and 9 months follow up, to collect data on individual´s adherence to protocol of mobile application.1,2 In addition to biomarkers, researchers will monitor changes in psychological variables.
Aims of the project and main hypotheses:
Methods:
The research is conceptualized as a randomized control trial employing a 4 × 4 factorial design. Participants will be randomly assigned to one of the four arms: 1. MBCT-Ca (Mindfulness Based Cognitive Therapy for Cancer) 2. PP (Positive Psychology) 3. AT (Autogenic training) 4.WL (Waiting list). Participants will take the 8 week online program via mobile application. Assessment measurements will be collected in four phases. Phase 1: Assessment at the start of the programme. Phase 2: Assessment in the week after programme completion. Phase 3: Follow-up assessment 3 months after the end of programme. Phase 4: Follow-up assessment 9 months after the end of programme. Data collection will contained: collection of blood samples, single lead ECG, administration of self-report measures. Main data collection points will be synchronized with regular check-ups for each participant to minimize drop-out rates and the burden on the participants.
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440 participants in 4 patient groups
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Central trial contact
Miroslav Světlák, PhD.; Jana Halámková, PhD.
Data sourced from clinicaltrials.gov
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