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

NCT05221970 | Unknown

• 1 other identifier: 2022NALET
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

psychological intervention, mHealth, cancer

Outcome Measures

Primary Outcomes (4)

• Change in symptoms of individual stress level using the Perceived Stress Scale

  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.

  baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

• Change in depression, anxiety and stres using the Depression, Anxiety and Stress Scale

  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.

  baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

• Change in positive mental health using the Positive Mental Health Scale

  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.

  baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

• Change in health-related quality of life using The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being

  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.

  baseline, week 9 from baseline, month 3 post-intervention, month 9 post-intervention

Secondary Outcomes (19)

• 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

• 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

Other Outcomes (1)

• Socio-demographic variables

  baseline

Study Arms (4)

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

OTHER

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

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

Positive Psychology - online

OTHER

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

Behavioral: Positive Psychology - online

Autogenic Training - online

OTHER

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

Behavioral: Autogenic Training - online

Waiting list

NO INTERVENTION

No intervention.

Interventions

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

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

Positive Psychology - online 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

Autogenic Training - online 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Masaryk University: lead
• Masaryk Memorial Cancer Institute: collaborator

Study Sites (1)

Faculty of Medicine, Masaryk University

Brno, Bohunice, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Mindfulness-Based Cognitive Therapy

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Miroslav Světlák, PhD

  Masaryk University

  STUDY CHAIR

Central Study Contacts

Miroslav Světlák, PhD

CONTACT

+420 549 49 1372; msvetlak@med.muni.cz

Alena Slezáčková, PhD

CONTACT

+420 604 506 256; alena.slezackova@med.muni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department head (Department of Psychology and Psychosomatics MUNI)

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: February 3, 2022
• Study Start: June 6, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)