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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

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.

Group Type OTHER

Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Positive Psychology - online

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Autogenic Training - online

Intervention Type BEHAVIORAL

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.

Group Type 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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Masaryk Memorial Cancer Institute

OTHER

Sponsor Role collaborator

Masaryk University

OTHER

Sponsor Role lead

Responsible Party

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Miroslav Světlák

Department head (Department of Psychology and Psychosomatics MUNI)

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Miroslav Světlák, PhD

Role: CONTACT

+420 549 49 1372

Alena Slezáčková, PhD

Role: CONTACT

+420 604 506 256

Facility Contacts

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Miroslav Světlák, PhD

Role: primary

549 49 1372

Other Identifiers

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2022NALET

Identifier Type: -

Identifier Source: org_study_id

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