Effectiveness and Suitability of the Online Mobile Application MOÚ MindCare for the Mental and Physical Health of Cancer Patients: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in symptoms of individual stress level using the Perceived Stress Scale
研究概览
简要总结
In this study, the researchers will examine the effects of a mental health supportive online mobile application called MOÚ MindCare to self-reported values of stress, anxiety, depression, emotion regulation, personality traits, rumination and reflection, sleep disturbance, fatigue, and severity of somatic symptoms in a sample of patients with cancer.
详细描述
Background: Promoting the mental health of cancer patients is one of the main pillars of comprehensive oncological care. Due to the insufficient capacity of psychotherapists and the mental and physical problems of cancer patients associated with treatment, classical face-to-face mental health support is not always available.
Objectives: 1. To evaluate the impact of online psychological interventions on selected parameters of mental and physical health in cancer patients. 2. To compare which type of psychological intervention is most suitable for which type of oncology patients. 3. To evaluate the moderating roles of intervention adherence and perceived acceptability in the effectiveness of the intervention programs.
Methods: The study design is RCT that includes 4 arms : 1. MBCT (Mindfulness Based Cognitive Therapy) 2. Positive Psychology 3. Autogenic Training 4. Waiting list. Participants will take the 8 week online program via mobile application. Outcomes will be assessed online at, 1) Baseline, 2) Post-intervention (PI), 3) 3 months post PI and 4) 9 months post PI.
Anticipated Findings: Completion of the 8-week online program will lead to the improvement of selected variables of psychological and physical health in oncology patients in comparison with the passive control group. It is expected that programs involving a cognitive component (MBCT-Ca and PP) will be more effective than AT. The investigators expect higher adherence and acceptability to be associated with greater improvement in the outcome variables.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over the age of 18
- •Diagnosis of some kind of cancer
- •Receiving some form of cancer treatment or finished cancer treatment
排除标准
- •Patients without a mobil device ("smart" mobile phone)
- •Patients without internet access
- •Patients suffering from some psychiatric disorder (Schizophrenia, Bipolar Affective Disorder, personality disorder associated with mood changes, Posttraumatic Stress Disorder, suicide attempt, suicide thoughts, Somatoform Disorder or other medically unexplained symptoms which, due to their severity, prevent the person concerned from daily life
- •Patients suffering during the last year from: depression with psychotic symptoms, panic anxiety, repeated hospitalization in psychiatry
结局指标
主要结局
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-Spiritual Well-Being
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 current emotional state using the Self-Assessment Manikin(during a whole intervention (3 times a day))
- 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)
- 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)
- The total amount of received health care using the medical documentation software (GreyFox)(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)
- 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)
- 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)
- Basic personality traits using the Big Five Inventory BFI-10(baseline)
- Change in rumination and reflection using the Rumination-Reflection Questionnaire(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)
- Change in fatigue using the Fatigue Symptom Inventory(baseline, week 9 from baseline, month 3 post-intervention, 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 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