Effectiveness and Suitability of the Online Mobile Application for the Mental and Physical Health of Cancer Patients

Masaryk University

Status: Enrolling

Conditions: Cancer

Treatments: Behavioral: Autogenic Training - online; Behavioral: Positive Psychology - online; Behavioral: Mindfulness-Based Cognitive Therapy (MBCT-Ca) - online

Study type: Interventional

Funder types: Other

Identifiers

NCT05221970

2022NALET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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600 participants in 4 patient groups

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

Other group

Description:

MBCT uses cognitive behavioral therapy (CBT) methods in collaboration with mindfulness meditative practices and similar psychological strategies.

Treatment:

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

Positive Psychology - online

Other group

Description:

Positive psychology is focused on the character strengths and behaviors that allow individuals to build a life of meaning and purpose.

Treatment:

Behavioral: Positive Psychology - online

Autogenic Training - online

Other group

Description:

Autogenic training is a relaxation technique focusing on promoting feelings of calm and relaxation to help reduce stress and anxieties.

Treatment:

Behavioral: Autogenic Training - online

Waiting list

No Intervention group

Description:

No intervention.