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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 440
- 试验地点
- 2
- 主要终点
- Change in heart rate variability (HRV) using ECG
研究概览
简要总结
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.
详细描述
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:
- 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.
- 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.
- 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.
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over the age of 18
- •Breast cancer patients at the end of adjuvant treatment
排除标准
- •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
结局指标
主要结局
Change in heart rate variability (HRV) using ECG
时间窗: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
HRV will be obtained from ECG measured according to a protocol involving a standardized sequence of measurements taken at rest with uncontrolled and controlled breathing. The completion of questionnaire related to rumination and impact of the cancer event before the measurement of rest ECG will serve as the priming of distress. The obtained data will be processed using the Kubios HRV Premium program- time-domain HRV parameters - RMSSD, SDNN, pNN50 and Power Spectrum density HRV parameters - LF power, HF power, and LF/HF ratio.
Change in symptoms of individual stress level using the Perceived Stress Scale
时间窗: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
The Perceived Stress Scale (PSS) is a classic stress assessment instrument. The questions in this scale ask about feelings and thoughts during the last month. Each question has five response options ranging in value from null to four (0=never; 1=almost never; 2=sometimes; 3=fairly often; 4=very often). To find the total raw score, sum the values of the response to each question (reverse code items 4, 5, 7a and 8). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Change in depression, anxiety and stres using the Depression, Anxiety and Stress Scale
时间窗: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
The Depression, Anxiety and Stress Scale (DASS-21) is a 21 items scale designed to measure depression, anxiety, and stress. The instrument comprises three subscales: the emotional states of depression, anxiety, and stress. Each question has four response options ranging in value from null to four (0= did not apply to me at all; 1= applied to me to some degree, or some of the time; 2= applied to me a considerable degree or a good part of time; 3= applied to me very much or most of the time). To find the total raw score, sum the values of the response to each question for each of subscale (scores will need to be multiplied by 2 to calculate the final score). The lowest possible raw score is 0 and the highest possible raw score is 42 for each subscale. A higher score represents more of the concept being measured.
Change in positive mental health using the Positive Mental Health Scale
时间窗: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
The Positive Mental Health Scale (PMHS) is a nine-item scale designed to measure positive mental health (combination of emotional, psychological, and social aspects of well-being). Each item on the questionnaire is scored from 0 (do not agree) - 3 (agree). The lowest possible raw score is 0 and the highest possible raw score is 27. A higher score represents more of the concept being measured.
Change in health-related quality of life using The Functional Assessment of Chronic Illness Therapy (FACIT)-Spiritual Well-Being (Sp)
时间窗: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
The Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT)-(Sp) is composed of the FACT-General (FACT-G) and a 12-item Spiritual Well-Being scale (FACIT-Sp-12).The FACT-G (Version 4) is a 27-item compilation of general questions divided into four primary QOL subscales: Physical Well-Being (PWB; 7-items), Social/Family Well-Being (SWB; 7-items), Emotional Well-Being (EWB; 6-items), and Functional Well-Being (FWB; 7-items).Each question has five response options ranging in value from null to four (0= not at all; 1= a little bit; 2=somewhat; 3= quite a bit; 4=very much). The total FACT-G score is obtained by summing individual subscale scores (PWB + EWB + SWB + FWB). The lowest possible raw score is 0 and the highest possible raw score is 48 in Spiritual Well-Being subscales. The lowest possible raw score is 0 and the highest possible raw score is 108 in FACT-G. A higher score represents more of the concept being measured.
次要结局
- 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+)(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in cytokine levels(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in levels of C-reactive protein (CRP)(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in serum cortisol level(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in current emotional state using the Self-Assessment Manikin(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)
- Adherence to/satisfaction with the MOÚ MindCare application and intervention programme using the MOÚ MindCare Feasibility Questionnaire(week 9 from baseline)
- Change in emotion dysregulation using the Difficulties in Emotion Regulation Scale-SF(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Five Facet Mindfulness Questionnaire-15(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Applied Mindfulness Process Scale(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Self- Compassion Scale(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in impact of event using the Impact of Event Scale-Revised(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in sleep quality using the Pittsburgh Sleep Quality Index(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Changes in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Gratitude Questionnaire Six-Item Form(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in transdiagnostic and transtheoretical indicators of positive and adaptive functioning using the Perceived Hope Scale(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in rumination and reflection using the Rumination-Reflection Questionnaire(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Basic personality traits using the Big Five Inventory BFI-10(baseline)
- Change in fatigue using the Fatigue Symptom Inventory(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- The total amount of received health care using the medical documentation software (GreyFox)(month 9 post-intervention)
- Changes in severity of somatic symptoms using the Patient Health Questionnaire 15(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in pain medication use(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in psychiatric medication use(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in pain intensity using the Numerical Rating Scale of Pain Intensity(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
- Change in dealing with pain using the Pain Self-Efficacy Questionnaire(baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention)
研究者
Miroslav Světlák
Department head (Department of Psychology and Psychosomatics MUNI)
Masaryk University