A New Mindfulness Intervention Called Mindfulness Based Swinging Technique (MBST) for Women With Breast Cancer

University of Barcelona

Status: Completed

Conditions: Self Efficacy; Hopefulness; Breast Cancer Female; Depression; Anxiety; Stress

Treatments: Behavioral: Mindfulness based Swinging Effect Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03985267

2018/14-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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156 participants in 2 patient groups

Mindfulness Based Swinging Technique (MBST)

Experimental group

Description:

Standard guided imagery combined with Mindfulness and breathing technique will be applied. Additionally, the directives will be given to participants to imagine themselves swinging in a green peaceful environment where they will face no harm but healing and full of wellness. Every time they imagine their swing goes up, patient will be asked to physically take a deep breath (taking the breath will be physically (actually) done, not imagining), and when going down patient will be asked to physically release their breath (releasing breath will be physically (actually) done, not imagining).

Treatment:

Behavioral: Mindfulness based Swinging Effect Intervention

Standard Treatment

Active Comparator group

Description:

Participants will receive a session of standard psycho-social care for anxiety (50 minutes length). The standard psycho-social care interventions involve the most well-known talking therapy approach of Cognitive Behavioural Therapy (CBT).

Treatment:

Behavioral: Mindfulness based Swinging Effect Intervention