Clinical trial NCT03985267: A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer
Official title: Efficacy of Mindfulness Based Swinging Technique (MBST) for Improving Anxiety, Stress, Hopelessness and Self Efficacy Among Breast Cancer Patients in Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Self Efficacy
Depression
Breast Cancer Female
Hopefulness
Keywords: mindfulness
breast cancer
psycho-oncology
clinical health psychology
ontology
swinging effect intervention
breathing technique
guided imagery
cognitive behavioural therapy
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is hypothesised to find that the new mindfulness intervention of Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer is an effective therapeutic intervention to be applied in breast cancer population. This intervention intended to support patients' management of their chronic illness (self-efficacy) by increasing their hope about their treatment and alleviate anxiety, as well as increase patient saturation level. Therefore, enabling patients to continue to their medical as well as psychological treatment will result improved anxiety, stress levels, hope and self-efficacy. It is known that mental health needs of cancer patients differ from people who do not suffer from a chronic illness.

Detailed description: Participation in this research is entirely voluntary. Participants are required to complete a semi-screening assessment form which asks socio-demographic and bio-medical information. This form is also assess participants eligibility to take part. Then will ask participants to complete the Hospital and Depression Scale (HADS), Self-Efficacy for Managing Chronic Disease (SEMCD), Beck's Hopelessness Scale (BHS), Emotion Thermometer (ET), State Trait Anxiety Inventory (STAI) before and after (pre-post) their allocated intervention (arm). Participants have the right to answer as many or as few questions asked as they wish. They also have the right to withdraw from the study up to four weeks after they have completed the required psychometric measurement tools. Should they wish to withdraw then they will need to inform the researcher by email, quoting their unique participation identification code which will be generated before beginning the study using their name initials and date of birth. This will enable researcher to identify all the materials that needs to be deleted due to their withdrawal from the project. Alternatively, if they decide that they no longer want to take part in the study they can notify the researcher/clinician immediately and their recorded information (if any) will be completely erased from the study. Other than answering a number of demographic questions (in order to establish the characteristics of the sample), participants will not be directly disclosing any confidential personal information. However, the survey completion data will be checked for any identifying information and anonymised if necessary. Participants will be allocated a code number, and this will be used when quoting from the data-set. The data will be kept confidential and stored in a safe locked cabinet/storage at all times. The ethical approval is obtained from one of the Turkish institution where they issue ethical approval in accordance with the ethical standards of the Helsinki declaration.

Eligibility criteria: Inclusion Criteria:

1. Age of 18 and over who can consent
2. Only women participants
3. Diagnosed with breast cancer
4. Native Turkish speaker
5. Currently under cancer treatment (not in remission)
6. Score at least 10 points for Hospital and Depression Scale (5 for anxiety, 5 for depression)
7. Score at least 6 points for Self-Efficacy for Managing Chronic Disease (in overall)
8. Score at least 2 points for the Beck's Hopelessness Scale (in overall)
9. Score at least 20 points for State Trait Anxiety Inventory.

Exclusion Criteria:

1. Being illiterate
2. Having any type of psychiatric history
3. Currently being on psychiatric/neurological medication
4. Having mental retardation
5. Having a fear of swings/swinging
6. Having a severe respiratory illness/severe difficulty in breathing
7. Suffering from any asthmatic or epileptic illnesses

Primary outcomes:
measure: Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety
timeFrame: 20minutes
measure: Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
timeFrame: 20 minutes
measure: Evaluation of the immediate efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
timeFrame: 20 minutes
measure: Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase self-efficacy
timeFrame: 8 weeks
measure: Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to increase hopefulness
timeFrame: 8 weeks
measure: Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the State Trait Anxiety Inventory.
timeFrame: 8 weeks
measure: Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using Emotion Thermometer.
timeFrame: 8 weeks
measure: Evaluation of the long lasting efficacy of the Mindfulness Based Swinging Technique (MBST) to reduce stress and anxiety using the Hospital Anxiety and Depression Scale.
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact of education level on efficacy of the Mindfulness Based Swinging Technique (MBST)
timeFrame: 20 minutes to 8 weeks
measure: Impact of marital status on efficacy of the Mindfulness Based Swinging Technique (MBST)
timeFrame: 20 minutes to 8 weeks
measure: Impact of living arrangements on efficacy of the Mindfulness Based Swinging Technique (MBST)
timeFrame: 20 minutes to 8 weeks
measure: Impact of time for learning cancer diagnosis on efficacy of the Mindfulness Based Swinging Technique (MBST)
timeFrame: 20 minutes to 8 weeks
measure: Impact of having any metastasis on efficacy of the Mindfulness Based Swinging Technique (MBST)
timeFrame: 20 minutes to 8 weeks
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ozel Oz Psikoloji Aile Danisma Merkezi (Oz Psychology Family Counselling Centre)
state: Konak
city: Aydın
country: Turkey
facility: EgeMed Hospital
state: Soke
Study officials:
affiliation: University of Barcelona
name: Jose M Maldonado, PhD, MSc
role: STUDY_DIRECTOR
References:
citation: Bahcivan O, Estape T, Gutierrez-Maldonado J. The swinging effect intervention: CBT based guided imagery and breathing technique integrated with mindfulness therapy for cancer patients. Med Hypotheses. 2018 Dec;121:42-43. doi: 10.1016/j.mehy.2018.09.007. Epub 2018 Sep 6. No abstract available.
citation: Bahcivan O, Estape T, Gutierrez-Maldonado J. Efficacy of New Mindfulness-Based Swinging Technique Intervention: A Pilot Randomised Controlled Trial Among Women With Breast Cancer. Front Psychol. 2022 Jul 4;13:863857. doi: 10.3389/fpsyg.2022.863857. eCollection 2022.