The Effectiveness of Psychological Interventions in Psycho-neuroendocrine-immune Network in Breast Cancer Survivors

NCT05406531 | Unknown

• 1 other identifier: AZV2022
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

Brief Summary

In this study researchers will examine an influence of three different psychological interventions in the form of mobile application on psycho-neuroendocrine-immune system among breast cancer survivors.

Conditions

Breast Cancer Female; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III

Keywords

Biomarkers; mHealth; psychological intervention

Outcome Measures

Primary Outcomes (5)

• Change in heart rate variability (HRV) using ECG

  HRV will be obtained from ECG measured according to a protocol involving a standardized sequence of measurements taken at rest with uncontrolled and controlled breathing. The completion of questionnaire related to rumination and impact of the cancer event before the measurement of rest ECG will serve as the priming of distress. The obtained data will be processed using the Kubios HRV Premium program- time-domain HRV parameters - RMSSD, SDNN, pNN50 and Power Spectrum density HRV parameters - LF power, HF power, and LF/HF ratio.

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

• 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 (FACIT)-Spiritual Well-Being (Sp)

  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 (23)

• Change in relative and absolute counts of B-lymphocytes (CD19+), T-lymphocytes, T-helper lymphocytes (CD3+ CD4+), T-cytotoxic lymphocytes (CD3+ CD8+), NK-cells (CD16+ CD56+), NK-T-like cells (CD3+ CD56+) and monocytes (CD14+)

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

• Change in cytokine levels

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

• Change in serum cortisol level

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

• Change in levels of C-reactive protein (CRP)

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

• Change in current emotional state using the Self-Assessment Manikin

  every single morning during a whole 8 weeks of intervention; every single afternoon during a whole 8 weeks of intervention; every single evening during a whole 8 weeks of intervention

Other Outcomes (1)

• Socio-demographic variables

  baseline

Study Arms (4)

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

EXPERIMENTAL

MBCT-Ca 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

EXPERIMENTAL

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

EXPERIMENTAL

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

You may qualify if:

• Women over the age of 18
• Breast cancer patients at the end of adjuvant treatment

You may not qualify if:

• Patients without a mobil device ("smart" mobile phone)
• Patients without internet access
• Patients with diagnosed: psychotic disorder; severe depressive episode; panic disorder; bipolar disorder; personality disorder associated with uncontrollable mood swings; PTSD; suicidal attempts and active suicidal ideation; disability pension due to non-specific mental or somatic problems; hospitalization due to a psychiatric disorder in the past year

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Medicine, Masaryk University

Brno, Bohunice, 62500, Czechia

RECRUITING

Related Publications (3)

• Sanada K, Alda Diez M, Salas Valero M, Perez-Yus MC, Demarzo MM, Montero-Marin J, Garcia-Toro M, Garcia-Campayo J. Effects of mindfulness-based interventions on biomarkers in healthy and cancer populations: a systematic review. BMC Complement Altern Med. 2017 Feb 23;17(1):125. doi: 10.1186/s12906-017-1638-y.

  PMID: 28231775 BACKGROUND

• Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.

  PMID: 26799456 BACKGROUND

• Heiss S, Vaschillo B, Vaschillo EG, Timko CA, Hormes JM. Heart rate variability as a biobehavioral marker of diverse psychopathologies: A review and argument for an "ideal range". Neurosci Biobehav Rev. 2021 Feb;121:144-155. doi: 10.1016/j.neubiorev.2020.12.004. Epub 2020 Dec 9.

  PMID: 33309905 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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

Jana Halámková, PhD.

CONTACT

+420 549 49 3759; jana.halamkova@mou.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: February 25, 2022
• First Posted: June 6, 2022
• Study Start: June 6, 2022
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)