The Effectiveness of Psychological Interventions in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors

Breast Cancer Female Clinical Trial

Official title: The Effectiveness of Mobile-based Psychological Interventions in Reducing Psychological Distress and Preventing Stress-related Changes in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors- Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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:

1. To test the long-term and short-term effectiveness of eHealth adaptations of three standardized mental health support programmes for cancer patients (MBCT-Ca, PP and AT) - administered through the mobile application MOÚ MindCare, in reducing psychological distress and preventing changes in the functioning of the autonomic nervous system, endocrine system and immune system that have been linked to chronic stress and are likely to have a negative impact on both mental and physical health in the long-term perspective if not managed. The investigators expect that participants in all three intervention group will show more adaptive psychological functioning, higher quality of life, lower levels of stress, depression, anxiety, fatigue, sleep disturbances and other common problems associated with breast cancer survivorship, higher HRV levels and lower cortisol levels as compared to the treatment-as-usual control group, when controlling for pre-intervention values. The investigators also expect group differences in immune system functioning, correlated with differences in other markers of stress.

2. To compare the potentially differential effects of the three intervention programmes on biological and psychological indicators of stress and quality of life. The investigators tentatively expect programmes involving a cognitive component (MBCT-Ca and PP) to be more effective than AT, especially for psychological outcomes.

3. To examine the extent to which the observed effects of each programme are mediated by characteristics the interventions are primarily expected to influence. The investigators expect the effect of MBCT to be primarily mediated by mindfulness, self-compassion and emotion regulation, and the effect of PP to be primarily mediated by self-compassion, gratitude and perceived hope.

4. To evaluate the moderating roles of intervention adherence and perceived acceptability in the effectiveness of the intervention programmes. The investigators expect higher adherence and acceptability to be associated with greater improvement in the outcome variables. These data will also help identify types of individuals for whom each programme might be most and least suitable and provide information on sources of potential problems with MOÚ MindCare - or generally mHealth - intervention adherence.

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. ;

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Cancer Stage III
• Breast Neoplasms

• NCT number: NCT05406531
• Study type: Interventional
• Source: Masaryk University
• Contact: Miroslav Svetlák, PhD.
• Phone: +420 549 49 1372
• Email: msvetlak@med.muni.cz
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Completion date: June 2025