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A New Mindfulness Approach Called Swinging Effect Intervention for Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT03985267
Recruitment Status : Active, not recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Ozan BAHCIVAN, University of Barcelona

Brief Summary:
It is hypothesised to find that the new mindfulness approach of Swinging Effect intervention 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.

Condition or disease Intervention/treatment Phase
Anxiety Stress Self Efficacy Depression Breast Cancer Female Hopefulness Behavioral: Mindfulness based Swinging Effect Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Efficacy of New Mindfulness-based Swinging Effect Intervention: A Randomised Control Trial Among Women With Breast Cancer
Actual Study Start Date : November 29, 2018
Actual Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Swinging Effect Intervention
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).
Behavioral: Mindfulness based Swinging Effect Intervention
Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.
Other Names:
  • Breathing Technique
  • Guided Imagery Technique
  • Cognitive Behavioural Therapy (CBT)
  • Mindfulness

Active Comparator: Standard Treatment
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).
Behavioral: Mindfulness based Swinging Effect Intervention
Participants will receive psycho-education about mindfulness and how it operates. That will also assist patients to warm up for the actual intervention. Then the actual swinging effect intervention will commence respectively.
Other Names:
  • Breathing Technique
  • Guided Imagery Technique
  • Cognitive Behavioural Therapy (CBT)
  • Mindfulness




Primary Outcome Measures :
  1. Evaluation of the immediate efficacy of the mindfulness based Swinging Effect intervention to reduce stress and anxiety [ Time Frame: 20minutes ]
    To assess the immediate outcome of the mindfulness based "Swinging Effect" technique whether it is an effective and reliable intervention to reduce stress and anxiety for breast cancer patients. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

  2. Evaluation of the immediate efficacy of the mindfulness based Swinging Effect intervention to increase self-efficacy [ Time Frame: 20 minutes ]
    To assess the immediate outcome of the mindfulness based "Swinging Effect" technique whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used right before and after the intervention. If two consecutive numbers are circled, the lower number will be coded (less self-efficacy). The score for the scale is the mean of the six items. If more than two items will be missing, scoring the scale will not happen. Higher number indicates higher self-efficacy.The higher values represent a better outcome for this scale.

  3. Evaluation of the immediate efficacy of the mindfulness based Swinging Effect intervention to increase hopefulness [ Time Frame: 20 minutes ]
    To assess the immediate outcome of the mindfulness based "Swinging Effect" technique whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used right before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

  4. Evaluation of the long lasting efficacy of the mindfulness based Swinging Effect intervention to increase self-efficacy [ Time Frame: 8 weeks ]
    To assess the long term follow up outcome of the mindfulness based "Swinging Effect" technique whether it is an effective and reliable intervention to increase self-efficacy for breast cancer patients. In order to assess the effectiveness, Self-Efficacy for Managing Chronic Disease (SEMCD) will be used before and after the intervention. Each of the 6 items are rated from 1 (not at all confident) to 10 (totally confident). The overall score is derived from the mean of the 6 items. The total minimum score will be 6 (very low self-efficacy), and maximum total score will be 60 (very high self-efficacy). Higher scores indicate a better self-efficacy.

  5. Evaluation of the long lasting efficacy of the mindfulness based Swinging Effect intervention to increase hopefulness [ Time Frame: 8 weeks ]
    To assess the long term follow up outcome of the mindfulness based "Swinging Effect" technique whether it is an effective and reliable intervention to increase hopefulness for breast cancer patients. In order to assess the effectiveness, Beck's Hopelessness Scale (BHS) will be used before and after the intervention. The total score ranges from 0 to 20, the scores will be summed up together with higher levels of hopelessness indicated by higher scores on the scale. The higher values represent a better outcome for this scale.

  6. Evaluation of the long lasting efficacy of the mindfulness based Swinging Effect intervention to reduce stress and anxiety using the State Trait Anxiety Inventory. [ Time Frame: 8 weeks ]
    To assess the long term follow up of the mindfulness based "Swinging Effect" technique for reducing stress and anxiety State Trait Anxiety Inventory will be used before and after the intervention. To calculate the total State Trait Anxiety Inventory score (range 20 - 80): the positive items (calm, relaxed, content) will be reverse scored so 1=4, 2=3, 3=2 and 4=1; sum all six scores; multiply total score by 20/6; according to Spielberger's manuals a 'normal' score is approx. 34 - 36.

  7. Evaluation of the long lasting efficacy of the mindfulness based Swinging Effect intervention to reduce stress and anxiety using Emotion Thermometer. [ Time Frame: 8 weeks ]
    To assess the long term follow up of the mindfulness based "Swinging Effect" technique for reducing stress and anxiety Emotion Thermometer will be used before and after the intervention. To calculate the Emotion Thermometer the fixed cut-offs will be used meaning that 0-3 (low) and 4-10 (high) on each component.

  8. Evaluation of the long lasting efficacy of the mindfulness based Swinging Effect intervention to reduce stress and anxiety using the Hospital Anxiety and Depression Scale. [ Time Frame: 8 weeks ]
    To assess the long term follow up of the mindfulness based "Swinging Effect" technique for reducing stress and anxiety Hospital Anxiety and Depression Scale will be used before and after the intervention. To calculate Hospital Anxiety and Depression Scale the cut of scores are 0-7 considered in normal range, 8-10 considered in Borderline abnormal (borderline case) and 11-21 considered in Abnormal (case) respectively.


Secondary Outcome Measures :
  1. Impact of education level on efficacy of the mindfulness based Swinging Effect Intervention [ Time Frame: 20 minutes to 8 weeks ]
    To observe whether breast cancer patients' education level has any impact on efficacy of the mindfulness based Swinging Effect intervention to reduce anxiety and increase self-efficacy and hopefulness.The participants' education level will be obtained from self-reported socio-demographic semi-screening assessment form.

  2. Impact of marital status on efficacy of the mindfulness based Swinging Effect Intervention [ Time Frame: 20 minutes to 8 weeks ]
    To observe whether breast cancer patients' marital status has any impact on efficacy of the mindfulness based Swinging Effect intervention. The participants' marital status will be obtained from self-reported socio-demographic semi-screening assessment form.

  3. Impact of living arrangements on efficacy of the mindfulness based Swinging Effect Intervention [ Time Frame: 20 minutes to 8 weeks ]
    To observe whether breast cancer patients' living arrangement has any impact on efficacy of the mindfulness based Swinging Effect intervention. The participants' living arrangement status will be obtained from self-reported socio-demographic semi-screening assessment form.

  4. Impact of time for learning cancer diagnosis on efficacy of the mindfulness based Swinging Effect Intervention [ Time Frame: 20 minutes to 8 weeks ]
    To observe whether breast cancer patients' time for learning their cancer diagnosis has any impact on efficacy of mindfulness based Swinging Effect intervention. The information of when participants have learnt their cancer diagnosis will be obtained from self-reported socio-demographic semi-screening assessment form.

  5. Impact of having any metastasis on efficacy of the mindfulness based Swinging Effect Intervention [ Time Frame: 20 minutes to 8 weeks ]
    To observe whether breast cancer patients' metastatic status has any impact on efficacy of mindfulness based Swinging Effect intervention. The participants' metastatic status will be obtained from self-reported socio-demographic semi-screening assessment form.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only biological gender will be considered
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985267


Locations
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Turkey
Ozel Oz Psikoloji Aile Danisma Merkezi (Oz Psychology Family Counselling Centre)
Izmir, Konak, Turkey
EgeMed Hospital
Aydın, Soke, Turkey
Sponsors and Collaborators
University of Barcelona
Investigators
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Study Director: Jose M Maldonado, PhD, MSc University of Barcelona

Publications:
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Responsible Party: Ozan BAHCIVAN, Principal Investigator, University of Barcelona
ClinicalTrials.gov Identifier: NCT03985267     History of Changes
Other Study ID Numbers: 2018/14-01
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: data results and outcome will be available to researchers once it is published on a journal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: within 1 year of completion of the study.
Access Criteria: it will be available through international publication in English.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ozan BAHCIVAN, University of Barcelona:
mindfulness
breast cancer
psycho-oncology
clinical health psychology
ontology
swinging effect intervention
breathing technique
guided imagery
cognitive behavioural therapy

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases