Clinical trial NCT05406531: The Effectiveness of Psychological Interventions in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer Female
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Keywords: Biomarkers
mHealth
psychological intervention
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Masaryk Memorial Cancer Institute
First posted: 2022-06-06
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Women over the age of 18
* Breast cancer patients at the end of adjuvant treatment

Exclusion Criteria:

* Patients without a mobil device ("smart" mobile phone)
* Patients without internet access
* Patients with diagnosed: psychotic disorder; severe depressive episode; panic disorder; bipolar disorder; personality disorder associated with uncontrollable mood swings; PTSD; suicidal attempts and active suicidal ideation; disability pension due to non-specific mental or somatic problems; hospitalization due to a psychiatric disorder in the past year

Primary outcomes:
measure: Change in heart rate variability (HRV) using ECG
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in symptoms of individual stress level using the Perceived Stress Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in depression, anxiety and stres using the Depression, Anxiety and Stress Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in positive mental health using the Positive Mental Health Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in health-related quality of life using The Functional Assessment of Chronic Illness Therapy (FACIT)-Spiritual Well-Being (Sp)
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
Secondary outcomes:
measure: Change in relative and absolute counts of B-lymphocytes (CD19+), T-lymphocytes, T-helper lymphocytes (CD3+ CD4+), T-cytotoxic lymphocytes (CD3+ CD8+), NK-cells (CD16+ CD56+), NK-T-like cells (CD3+ CD56+) and monocytes (CD14+)
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in cytokine levels
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in serum cortisol level
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in levels of C-reactive protein (CRP)
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in current emotional state using the Self-Assessment Manikin
timeFrame: every single morning during a whole 8 weeks of intervention; every single afternoon during a whole 8 weeks of intervention; every single evening during a whole 8 weeks of intervention
measure: Adherence to/satisfaction with the MOÚ MindCare application and intervention programme using the MOÚ MindCare Feasibility Questionnaire
timeFrame: week 9 from baseline
measure: Change in emotion dysregulation using the Difficulties in Emotion Regulation Scale-SF
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Five Facet Mindfulness Questionnaire-15
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Applied Mindfulness Process Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Self- Compassion Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Gratitude Questionnaire Six-Item Form
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Perceived Hope Scale
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Basic personality traits using the Big Five Inventory BFI-10
timeFrame: baseline
measure: Change in rumination and reflection using the Rumination-Reflection Questionnaire
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in impact of event using the Impact of Event Scale-Revised
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in sleep quality using the Pittsburgh Sleep Quality Index
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in fatigue using the Fatigue Symptom Inventory
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: The total amount of received health care using the medical documentation software (GreyFox)
timeFrame: month 9 post-intervention
measure: Changes in severity of somatic symptoms using the Patient Health Questionnaire 15
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in pain medication use
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in psychiatric medication use
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in pain intensity using the Numerical Rating Scale of Pain Intensity
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
measure: Change in dealing with pain using the Pain Self-Efficacy Questionnaire
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
Other outcomes:
measure: Socio-demographic variables
timeFrame: baseline
Locations:
city: Brno
country: Czechia
facility: Faculty of Medicine, Masaryk University
state: Bohunice
Study officials:
affiliation: Masaryk University
name: Miroslav Světlák, PhD.
role: STUDY_CHAIR
References:
citation: Sanada K, Alda Diez M, Salas Valero M, Perez-Yus MC, Demarzo MM, Montero-Marin J, Garcia-Toro M, Garcia-Campayo J. Effects of mindfulness-based interventions on biomarkers in healthy and cancer populations: a systematic review. BMC Complement Altern Med. 2017 Feb 23;17(1):125. doi: 10.1186/s12906-017-1638-y.
citation: Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.
citation: Heiss S, Vaschillo B, Vaschillo EG, Timko CA, Hormes JM. Heart rate variability as a biobehavioral marker of diverse psychopathologies: A review and argument for an "ideal range". Neurosci Biobehav Rev. 2021 Feb;121:144-155. doi: 10.1016/j.neubiorev.2020.12.004. Epub 2020 Dec 9.