Clinical trial NCT05221970: Effectiveness and Suitability of the Online Mobile Application for the Mental and Physical Health of Cancer Patients
Official title: Effectiveness and Suitability of the Online Mobile Application MOÚ MindCare for the Mental and Physical Health of Cancer Patients: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: psychological intervention, mHealth, cancer
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Masaryk Memorial Cancer Institute
First posted: 2022-02-03
Enrollment: 600
Sex: ALL
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, 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men and women over the age of 18
* Diagnosis of some kind of cancer
* Receiving some form of cancer treatment or finished cancer treatment

Exclusion Criteria:

* 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

Primary outcomes:
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-Spiritual Well-Being
timeFrame: baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention
Secondary outcomes:
measure: Change in current emotional state using the Self-Assessment Manikin
timeFrame: during a whole intervention (3 times a day)
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: 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: The total amount of received health care using the medical documentation software (GreyFox)
timeFrame: 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: