Effectiveness and Suitability of the Online Mobile Application for the Mental and Physical Health of Cancer Patients
NCT ID: NCT05221970
Last Updated: 2023-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2022-06-06
2023-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online
MBCT uses cognitive behavioral therapy (CBT) methods in collaboration with mindfulness meditative practices and similar psychological strategies.
Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Positive Psychology - online
Positive psychology is focused on the character strengths and behaviors that allow individuals to build a life of meaning and purpose.
Positive Psychology - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Autogenic Training - online
Autogenic training is a relaxation technique focusing on promoting feelings of calm and relaxation to help reduce stress and anxieties.
Autogenic Training - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Waiting list
No intervention.
No interventions assigned to this group
Interventions
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Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Positive Psychology - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Autogenic Training - online
This intervention can be adapted into low-intensity structured program, suitable for eHealth mental health support applications for individual use without the need of direct involvement of a trained mental health professional.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of some kind of cancer
* Receiving some form of cancer treatment or finished cancer treatment
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Masaryk Memorial Cancer Institute
OTHER
Masaryk University
OTHER
Responsible Party
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Miroslav Světlák
Department head (Department of Psychology and Psychosomatics MUNI)
Principal Investigators
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Miroslav Světlák, PhD
Role: STUDY_CHAIR
Masaryk University
Locations
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Faculty of Medicine, Masaryk University
Brno, Bohunice, Czechia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022NALET
Identifier Type: -
Identifier Source: org_study_id
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