<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03305952</url>
  </required_header>
  <id_info>
    <org_study_id>CBCT-IVO</org_study_id>
    <nct_id>NCT03305952</nct_id>
  </id_info>
  <brief_title>Cognitively-Based Compassion Training for Breast Cancer Survivors</brief_title>
  <acronym>CBCT-BC</acronym>
  <official_title>Cognitively-Based Compassion Training (CBCT) for the Improvement of Health Related Quality of Life, Fear of Illness Recurrence, Compassion and Self-compassion in Breast Cancer Survivors Sample</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is a growing number of evidence of how mindfulness training enhances psychological and&#xD;
      physical well-being and coping strategies in patients with oncological illnesses. However,&#xD;
      there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast&#xD;
      cancer survivors.&#xD;
&#xD;
      The goal of this study is to analyze enrollment, participant satisfaction and adherence to&#xD;
      program and differences in psychological well-being, health related quality of life, fear of&#xD;
      illness recurrence, compassion and self-compassion variables after a Compassion-Based&#xD;
      Intervention in a Spanish breast cancer survivor sample.&#xD;
&#xD;
      This study is a randomized clinical trial of a secularized intervention called&#xD;
      Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to&#xD;
      CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT&#xD;
      intervention condition were asked to meet weekly for a two (2) hour long session during two&#xD;
      months. Pre-post-intervention and six month follow-up measures took place to evaluate:&#xD;
      psychological well-being (somatic, depressive, and anxious symptomatology), health related&#xD;
      quality of life (physical, social, emotional, and functional); psychological stress, coping&#xD;
      strategies and triggering cognitions linked to cancer recurrence fear, self-compassion,&#xD;
      compassion and mindfulness and awareness in both intervention and wait list groups.&#xD;
&#xD;
      CBCT is a promising and potentially useful intervention to enhance physical and emotional&#xD;
      well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and&#xD;
      a process of cultural adaptation required.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 1 in 8 U.S. women (around 12%) will develop invasive Breast Cancer (BC) over the course&#xD;
      of his/her lifetime. In 2015 there were 231,840 new cases of Breast Cancer (BC) in the United&#xD;
      States and it is this type of cancer with more new cases from all the rest. In 2017, an&#xD;
      estimated 252,710 new cases of invasive BC are expected to be diagnosed in women in the U.S.,&#xD;
      along with 63,410 new cases of non-invasive (in situ) BC. In Spain, there are around 21,000&#xD;
      new cases of BC every year. Among the different types of cancer, this is the one that shows&#xD;
      higher incidence, mortality, and prevalence to 5 years (29%, 15.5%, and 40.8%, respectively).&#xD;
&#xD;
      Common to all organic illnesses, BC has a number of associated physical, social and&#xD;
      psychological impairments, like problems of adaptation, difficulties in communication, or&#xD;
      depressive and anxious symptoms. Psychological and emotional stress in patients increases the&#xD;
      experience of pain, reduces the overall performance and is a fundamental factor of suicidal&#xD;
      ideation and suicide attempts.&#xD;
&#xD;
      In addition to having to deal with intrusive medical procedures and treatment (chemotherapy&#xD;
      and/or radiotherapy) side effects, BC patients treatment requires a significant psychological&#xD;
      adaptation. Furthermore, once treatment is finished, the fear of cancer recurrence occurs in&#xD;
      around 70% of the patients, which is associated with long-term functional impairments. In&#xD;
      addition, in nearly half of the survivors, intrusive thoughts about the disease and its&#xD;
      treatment (unwanted thoughts, images and memories) occur years after successful treatment. In&#xD;
      such patients, it has been observed that even when the rates of depression decreased, overall&#xD;
      well-being does not improve. Fatigue and sleep problems are also clinically significant in&#xD;
      60% of these kinds of patients, which creates imbalances both functional and in quality of&#xD;
      life.&#xD;
&#xD;
      Nowadays there are many psychological interventions that have been shown to be beneficial for&#xD;
      patients with BC. The most used and with a bigger body of evidence are those interventions of&#xD;
      cognitive-behavioral nature. There are three areas where cognitive-behavioral interventions&#xD;
      have had a greater impact on breast cancer patients' care: (1) treatment for pain relief; (2)&#xD;
      control of the aversive reactions of chemotherapy; and (3) improvement of emotional&#xD;
      well-being.&#xD;
&#xD;
      In recent years, interest in Mindfulness-Based Interventions (MBI) research for breast cancer&#xD;
      patients has increased, especially for those who have passed the initial malignancy and its&#xD;
      treatment, but often have to deal with functional, behavioral and persistent emotional&#xD;
      difficulties, such as depression, fatigue, fear of illness recurrence and cognitive&#xD;
      impairments. A Systematic review has shown positive results as an effective coping strategy&#xD;
      that diminishes anxiety, stress, fatigue, general mood, sleep disturbances, and enhances&#xD;
      quality of life.&#xD;
&#xD;
      Like Mindfulness, compassion can be trained using specific techniques and protocols&#xD;
      (Compassion-Based Intervention, CBI) designed specifically for this purpose. As a matter of&#xD;
      fact, for some authors CBIs may provide useful tools and resources to treat and prevent&#xD;
      various types of psychological difficulties (resources for interpersonal relationships,&#xD;
      reduction of depressive symptomatology, reduction of social anxiety, marital conflict, anger&#xD;
      management and dealing with the difficulties of being a caregiver).&#xD;
&#xD;
      In one study authors found how a CBI was associated with decreasing innate immune responses&#xD;
      to a psychosocial stressor. One research showed how loving-kindness (an ability often trained&#xD;
      in CBIs) practice was associated with less pain during that whole day and lower anger during&#xD;
      the next. Another study observed study observed how a CBI could significantly reduce the&#xD;
      feeling of loneliness and increase positive emotions. Some authors found an increase in&#xD;
      positive emotions in everyday experiences after training in compassion, which, in turn,&#xD;
      enhanced personal resources (purpose in life, social connection, and decrease in disease&#xD;
      symptoms). Although there are numerous studies on compassion and self-compassion in different&#xD;
      types of healthy populations and in clinical settings, there are hardly any data on the&#xD;
      benefits of CBIs in cancer patients.&#xD;
&#xD;
      Cognitively-Based Compassion Training (CBCT) is a secular protocol to teach compassion. The&#xD;
      foundational technique that CBCT uses to bring about a shift in perspective is to ground the&#xD;
      individual in a non-judgmental attentiveness to the present moment, followed by cognitive&#xD;
      exercises or analytical meditations. CBCT Program has shown to be effective in reducing&#xD;
      hormone levels related to psychoimmunological stress systems, as well as regulation of&#xD;
      inflammatory processes in adolescent population with early life adverse events. Recently, a&#xD;
      study found that CBCT program was a potentially effective and beneficial intervention and&#xD;
      highly satisfactory for the psychological well-being of breast cancer survivors.&#xD;
      Nevertheless, effects of CBCT on health-related quality of life, general well-being,&#xD;
      mindfulness facets, self-compassion and compassion traits have not yet been shown.&#xD;
&#xD;
      The goal of this study was to analyze the efficacy of CBCT Protocol in a Randomized Clinical&#xD;
      Trial (RCT) on a sample of breast cancer survivors over physical and psychological well-being&#xD;
      (somatic, depressive, anxious symptomatology); health-related quality of life (physical,&#xD;
      social, emotional and functional quality of life); psychological dimensions linked to fear of&#xD;
      cancer recurrence, levels of Mindfulness facets, Self-Compassion and Compassion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 11, 2016</start_date>
  <completion_date type="Anticipated">July 18, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 18, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4)</measure>
    <time_frame>8 weeks, 6 months</time_frame>
    <description>Designed to assess health related quality of life in breast cancer. Consists of 37 items and respondents are asked to indicate on a scale from 0 (not at all) through 4 (very much). Composed by five factors: physical quality of life; social / family and social quality of life; emotional quality of life; functional quality of life; and other concerns. FACT-B+4 has shown to have good. (Brady et al., 1997; Belmonte Martinez et al., 2011)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change Brief Symptom Inventory [BSI-18]</measure>
    <time_frame>8 weeks, 6 months</time_frame>
    <description>BSI-18 measures general psychological distress, which consists of 18 descriptions of physical and emotional complaints; respondents are asked to indicate on a scale from 0 (not at all) through 4 (very much) to what extent they are troubled by the complaints. This scale is composed by 3 factors: Somatization, which refers to the discomfort caused by the perception of physical symptoms and body dysfunction.BSI-18 has shown to have good psychometric properties (Derogatis, 2001; Andreu et al., 2008)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Self-Compassion Scale-Short Form (SCS-SF)</measure>
    <time_frame>8 weeks, 6 months</time_frame>
    <description>Designed to assess common humanity, mindfulness, self-judgment, over-identification, isolation, self-kindness and overall self-compassion. Composed by 12 items in its short verssion rated on a Likert scale from 1 (almost never) to 5 (almost always) with the total score derived by adding the means of each subscale together..SCS-SF has shown to have good (Raes, Pommier, Neff, &amp; Van Gucht, 2011; Garcia-Campayo et al., 2014)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in The Compassion Scale (CS)</measure>
    <time_frame>8 weeks, 6 months</time_frame>
    <description>A 24-item scale designed to assess compassion based on the six factor model of Neff's Self-Compassion Scale (Neff, 2003). In this study only the Total Compassion Score was utilized.CS has shown to have good (Pommier, 2010)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Five Facets of Mindfulness Questionnaire - short form (FFMQ-SF)</measure>
    <time_frame>8 weeks, 6 months</time_frame>
    <description>Measures participant's Mindfuless states and traits in daily life. It consists of 20 items rated on a scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Itassess five factors of mindfulness: Observe, Describe,Acting with awareness, Non-judging of inner experience,and Non-reactivity to inner experience. FFMQ has shown to have good ((Tran, Glück, &amp; Nader, 2013; Tran et al., 2014).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Fear of Cancer Recurrence Inventory (FCRI)</measure>
    <time_frame>8 weeks to six months</time_frame>
    <description>Designed to assess psychological stress and functional difficulties linked to cancer recurrence fear. Consists of 42-items that constitue seven components. In this study we only used 4 factors:(1) Triggers; (2) Psychological Distress; (3) Coping strategies; and (4) Insight. FCRI has shown to have good (Simard &amp; Savard, 2009).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>High attendance (6 sessions) with protocol (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)&amp; whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High minutes of home practice (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)&amp; whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High percentage of home practice with recordings (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)&amp; whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High frequency of practice between sessions (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6) whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High percentage of intention to attend to future CBCT® Program courses (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High recommendation rate of CBCT® Program courses (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High satisfaction rate with CBCT® Program instructor's performance (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <other_outcome>
    <measure>High intention rate to continue with daily practice at home (CBCT® Evaluation Survey)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>Compassion</condition>
  <condition>Treatment as Usual</condition>
  <arm_group>
    <arm_group_label>Compassion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CBCT was facilitated in an eight weekly, 2-h sessions format through didactics, class discussion, and guided meditation practice. Topics covered in order were: Week 1: Developing attention stability and mental clarity. Week 2. Open awareness of sensations, feelings, and emotions. Week 3: Self-Compassion. Week 4: Practice in impartiality and cultivation of social connection. Week 5: Practice in appreciation, gratitude, social interconnection, and interdependence. Session 6: Practice in affection (endearment) for developing undifferentiated affection for others. Week 7: Development of the aspirational wish that all beings be happy and free from suffering and its causes. Week 8: Active compassion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual (TAU) consisted of usual periodical visits to psycho oncologist based on hospital's regular calendar. Hospital's standard treatment was applied to participants. The standard treatment consists of counselling interventions, cognitive-behavioural interventions, family interventions, third generation interventions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBCT</intervention_name>
    <arm_group_label>Compassion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAU</intervention_name>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being aged between 35 and 75 years,&#xD;
&#xD;
          -  Being able to read and write using the Spanish language,&#xD;
&#xD;
          -  History of treated Breast Cancer within the past 15 years,&#xD;
&#xD;
          -  Free from oncological illness&#xD;
&#xD;
          -  Not receiving any kind of chemotherapy and / or radiotherapy treatment during study.&#xD;
&#xD;
        Eligible participants were contacted by their personal psychooncologist either by a&#xD;
        telephone call or at psychooncology appointment periodical visit to invite them to an&#xD;
        explanatory meeting of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active severe mental disorders (schizophrenia, bipolar disorder, eating disorders, and&#xD;
             major depression),&#xD;
&#xD;
          -  Substance use disorders, cognitive impairment,&#xD;
&#xD;
          -  Impaired medical condition.&#xD;
&#xD;
        Past and current psychiatric and medical history was determined by clinician assessment&#xD;
        with the Mini International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997)&#xD;
        Spanish version (Lobo et al., 1999).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edgar Gonzalez-Hernandez</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de València</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rebeca Diego Pedro, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de València</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rocío Romero Retes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundación Instituto Valenciano de Oncología</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Campos Bacas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat Jaume I</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lobsang Tenzin Negi aka Satya Dev Negi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University / Emory-Tibet Partnership</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Diana Burichka</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitat de València</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ausiàs Cebolla Martí, PhD</last_name>
    <phone>+34 96 386 44 07</phone>
    <email>ausias.cebolla@uv.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rosa Baños Rivera, PhD</last_name>
    <phone>+34 96 386 44 12</phone>
    <email>Rosa.Banos@uv.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fundación Instituto Valenciano de Oncología</name>
      <address>
        <city>Valencia</city>
        <zip>46009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rocio Romero Retes, PhD</last_name>
      <phone>0034 96 111 43 17</phone>
      <email>rromero@fivo.org</email>
    </contact>
    <contact_backup>
      <last_name>Edgar González Hernández</last_name>
      <phone>0034 63 640 55 61</phone>
      <email>info@mentivida.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.breastcancer.org/symptoms/understand_bc/statistics</url>
    <description>Weiss, M. C. (2017). U.S. breast cancer statistics.</description>
  </link>
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    <citation>Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.</citation>
    <PMID>25559415</PMID>
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    <citation>Rosenfeld, B., Krivo, S., Breitbart, W., &amp; Chochinov, H. M. (2000). Suicide, assisted suicide, and euthanasia in the terminally ill.</citation>
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    <citation>Rosedale M. Survivor loneliness of women following breast cancer. Oncol Nurs Forum. 2009 Mar;36(2):175-83. doi: 10.1188/09.ONF.175-183.</citation>
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    <PMID>22762896</PMID>
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    <citation>Negi, L. T. (2103). Emory compassion meditation protocol: Cognitively-based compassion training manualemory compassion meditation protocol: Cognitively-based compassion training manual. Atlanta: Emory University.</citation>
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    <citation>Moorey, S. (2007). Breast cancer and body image. The Female Body in Mind: The Interface between the Female Body and Mental Health, , 72.</citation>
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  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 8, 2017</last_update_submitted>
  <last_update_submitted_qc>October 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Rosa María Baños Rivera</investigator_full_name>
    <investigator_title>Full professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03305952
org study id: CBCT-IVO
nct id: NCT03305952
lead sponsor: 
has dmc: Yes
There is a growing number of evidence of how mindfulness training enhances psychological and
      physical well-being and coping strategies in patients with oncological illnesses. However,
      there are very few studies analyzing the efficacy of Compassion-Based Interventions on breast
      cancer survivors.

      The goal of this study is to analyze enrollment, participant satisfaction and adherence to
      program and differences in psychological well-being, health related quality of life, fear of
      illness recurrence, compassion and self-compassion variables after a Compassion-Based
      Intervention in a Spanish breast cancer survivor sample.

      This study is a randomized clinical trial of a secularized intervention called
      Cognitively-Based Compassion Training (CBCT). Subjects (n = 58) were randomly assigned to
      CBCT (n = 28) or a treatment as usual control group (TAU) (n = 28). Participants in the CBCT
      intervention condition were asked to meet weekly for a two (2) hour long session during two
      months. Pre-post-intervention and six month follow-up measures took place to evaluate:
      psychological well-being (somatic, depressive, and anxious symptomatology), health related
      quality of life (physical, social, emotional, and functional); psychological stress, coping
      strategies and triggering cognitions linked to cancer recurrence fear, self-compassion,
      compassion and mindfulness and awareness in both intervention and wait list groups.

      CBCT is a promising and potentially useful intervention to enhance physical and emotional
      well-being in breast cancer survivors. Nevertheless, future randomized trials are needed and
      a process of cultural adaptation required.
About 1 in 8 U.S. women (around 12%) will develop invasive Breast Cancer (BC) over the course
      of his/her lifetime. In 2015 there were 231,840 new cases of Breast Cancer (BC) in the United
      States and it is this type of cancer with more new cases from all the rest. In 2017, an
      estimated 252,710 new cases of invasive BC are expected to be diagnosed in women in the U.S.,
      along with 63,410 new cases of non-invasive (in situ) BC. In Spain, there are around 21,000
      new cases of BC every year. Among the different types of cancer, this is the one that shows
      higher incidence, mortality, and prevalence to 5 years (29%, 15.5%, and 40.8%, respectively).

      Common to all organic illnesses, BC has a number of associated physical, social and
      psychological impairments, like problems of adaptation, difficulties in communication, or
      depressive and anxious symptoms. Psychological and emotional stress in patients increases the
      experience of pain, reduces the overall performance and is a fundamental factor of suicidal
      ideation and suicide attempts.

      In addition to having to deal with intrusive medical procedures and treatment (chemotherapy
      and/or radiotherapy) side effects, BC patients treatment requires a significant psychological
      adaptation. Furthermore, once treatment is finished, the fear of cancer recurrence occurs in
      around 70% of the patients, which is associated with long-term functional impairments. In
      addition, in nearly half of the survivors, intrusive thoughts about the disease and its
      treatment (unwanted thoughts, images and memories) occur years after successful treatment. In
      such patients, it has been observed that even when the rates of depression decreased, overall
      well-being does not improve. Fatigue and sleep problems are also clinically significant in
      60% of these kinds of patients, which creates imbalances both functional and in quality of
      life.

      Nowadays there are many psychological interventions that have been shown to be beneficial for
      patients with BC. The most used and with a bigger body of evidence are those interventions of
      cognitive-behavioral nature. There are three areas where cognitive-behavioral interventions
      have had a greater impact on breast cancer patients' care: (1) treatment for pain relief; (2)
      control of the aversive reactions of chemotherapy; and (3) improvement of emotional
      well-being.

      In recent years, interest in Mindfulness-Based Interventions (MBI) research for breast cancer
      patients has increased, especially for those who have passed the initial malignancy and its
      treatment, but often have to deal with functional, behavioral and persistent emotional
      difficulties, such as depression, fatigue, fear of illness recurrence and cognitive
      impairments. A Systematic review has shown positive results as an effective coping strategy
      that diminishes anxiety, stress, fatigue, general mood, sleep disturbances, and enhances
      quality of life.

      Like Mindfulness, compassion can be trained using specific techniques and protocols
      (Compassion-Based Intervention, CBI) designed specifically for this purpose. As a matter of
      fact, for some authors CBIs may provide useful tools and resources to treat and prevent
      various types of psychological difficulties (resources for interpersonal relationships,
      reduction of depressive symptomatology, reduction of social anxiety, marital conflict, anger
      management and dealing with the difficulties of being a caregiver).

      In one study authors found how a CBI was associated with decreasing innate immune responses
      to a psychosocial stressor. One research showed how loving-kindness (an ability often trained
      in CBIs) practice was associated with less pain during that whole day and lower anger during
      the next. Another study observed study observed how a CBI could significantly reduce the
      feeling of loneliness and increase positive emotions. Some authors found an increase in
      positive emotions in everyday experiences after training in compassion, which, in turn,
      enhanced personal resources (purpose in life, social connection, and decrease in disease
      symptoms). Although there are numerous studies on compassion and self-compassion in different
      types of healthy populations and in clinical settings, there are hardly any data on the
      benefits of CBIs in cancer patients.

      Cognitively-Based Compassion Training (CBCT) is a secular protocol to teach compassion. The
      foundational technique that CBCT uses to bring about a shift in perspective is to ground the
      individual in a non-judgmental attentiveness to the present moment, followed by cognitive
      exercises or analytical meditations. CBCT Program has shown to be effective in reducing
      hormone levels related to psychoimmunological stress systems, as well as regulation of
      inflammatory processes in adolescent population with early life adverse events. Recently, a
      study found that CBCT program was a potentially effective and beneficial intervention and
      highly satisfactory for the psychological well-being of breast cancer survivors.
      Nevertheless, effects of CBCT on health-related quality of life, general well-being,
      mindfulness facets, self-compassion and compassion traits have not yet been shown.

      The goal of this study was to analyze the efficacy of CBCT Protocol in a Randomized Clinical
      Trial (RCT) on a sample of breast cancer survivors over physical and psychological well-being
      (somatic, depressive, anxious symptomatology); health-related quality of life (physical,
      social, emotional and functional quality of life); psychological dimensions linked to fear of
      cancer recurrence, levels of Mindfulness facets, Self-Compassion and Compassion.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4)
time frame: 8 weeks, 6 months
description: Designed to assess health related quality of life in breast cancer. Consists of 37 items and respondents are asked to indicate on a scale from 0 (not at all) through 4 (very much). Composed by five factors: physical quality of life; social / family and social quality of life; emotional quality of life; functional quality of life; and other concerns. FACT-B+4 has shown to have good. (Brady et al., 1997; Belmonte Martinez et al., 2011)
measure: Change Brief Symptom Inventory [BSI-18]
time frame: 8 weeks, 6 months
description: BSI-18 measures general psychological distress, which consists of 18 descriptions of physical and emotional complaints; respondents are asked to indicate on a scale from 0 (not at all) through 4 (very much) to what extent they are troubled by the complaints. This scale is composed by 3 factors: Somatization, which refers to the discomfort caused by the perception of physical symptoms and body dysfunction.BSI-18 has shown to have good psychometric properties (Derogatis, 2001; Andreu et al., 2008)
measure: Change Self-Compassion Scale-Short Form (SCS-SF)
time frame: 8 weeks, 6 months
description: Designed to assess common humanity, mindfulness, self-judgment, over-identification, isolation, self-kindness and overall self-compassion. Composed by 12 items in its short verssion rated on a Likert scale from 1 (almost never) to 5 (almost always) with the total score derived by adding the means of each subscale together..SCS-SF has shown to have good (Raes, Pommier, Neff, & Van Gucht, 2011; Garcia-Campayo et al., 2014)
measure: Change in The Compassion Scale (CS)
time frame: 8 weeks, 6 months
description: A 24-item scale designed to assess compassion based on the six factor model of Neff's Self-Compassion Scale (Neff, 2003). In this study only the Total Compassion Score was utilized.CS has shown to have good (Pommier, 2010)
measure: Change in Five Facets of Mindfulness Questionnaire - short form (FFMQ-SF)
time frame: 8 weeks, 6 months
description: Measures participant's Mindfuless states and traits in daily life. It consists of 20 items rated on a scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Itassess five factors of mindfulness: Observe, Describe,Acting with awareness, Non-judging of inner experience,and Non-reactivity to inner experience. FFMQ has shown to have good ((Tran, Glück, & Nader, 2013; Tran et al., 2014).
measure: Change in Fear of Cancer Recurrence Inventory (FCRI)
time frame: 8 weeks to six months
description: Designed to assess psychological stress and functional difficulties linked to cancer recurrence fear. Consists of 42-items that constitue seven components. In this study we only used 4 factors:(1) Triggers; (2) Psychological Distress; (3) Coping strategies; and (4) Insight. FCRI has shown to have good (Simard & Savard, 2009).
measure: High attendance (6 sessions) with protocol (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)& whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High minutes of home practice (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)& whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High percentage of home practice with recordings (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)& whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High frequency of practice between sessions (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6) whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High percentage of intention to attend to future CBCT® Program courses (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High recommendation rate of CBCT® Program courses (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High satisfaction rate with CBCT® Program instructor's performance (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
measure: High intention rate to continue with daily practice at home (CBCT® Evaluation Survey)
time frame: 8 weeks
description: Designed to assess acceptance and adherence to the CBCT® Program. It consists of 20 items that evaluate: (1) attendance, (2) time (minutes) of home practice, (3) whether participants practiced with audio recordings or not, (4) frequency of practice, (5) whether participants intend to attend to future CBCT® Program courses or not,(6)whether participants would recommend CBCT® Program or not, (7) satisfaction with CBCT® Program instructor's performance and (8) whether participants intend to continue with daily practice at home.
arm group label: Compassion
arm group type: Experimental
description: CBCT was facilitated in an eight weekly, 2-h sessions format through didactics, class discussion, and guided meditation practice. Topics covered in order were: Week 1: Developing attention stability and mental clarity. Week 2. Open awareness of sensations, feelings, and emotions. Week 3: Self-Compassion. Week 4: Practice in impartiality and cultivation of social connection. Week 5: Practice in appreciation, gratitude, social interconnection, and interdependence. Session 6: Practice in affection (endearment) for developing undifferentiated affection for others. Week 7: Development of the aspirational wish that all beings be happy and free from suffering and its causes. Week 8: Active compassion
arm group label: Treatment as usual
arm group type: Active Comparator
description: Treatment as usual (TAU) consisted of usual periodical visits to psycho oncologist based on hospital's regular calendar. Hospital's standard treatment was applied to participants. The standard treatment consists of counselling interventions, cognitive-behavioural interventions, family interventions, third generation interventions.
intervention type: Behavioral
intervention name: CBCT
arm group label: Compassion
intervention type: Other
intervention name: TAU
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 25 Years
maximum age: 75 Years
healthy volunteers: No
last name: Edgar Gonzalez-Hernandez
role: Principal Investigator
affiliation: Universitat de València
last name: Rebeca Diego Pedro, PhD
role: Principal Investigator
affiliation: Universitat de València
last name: Rocío Romero Retes, PhD
role: Principal Investigator
affiliation: Fundación Instituto Valenciano de Oncología
last name: Daniel Campos Bacas, PhD
role: Principal Investigator
affiliation: Universitat Jaume I
last name: Lobsang Tenzin Negi aka Satya Dev Negi, PhD
role: Principal Investigator
affiliation: Emory University / Emory-Tibet Partnership
last name: Diana Burichka
role: Principal Investigator
affiliation: Universitat de València
last name: Ausiàs Cebolla Martí, PhD
phone: +34 96 386 44 07
email: ausias.cebolla@uv.es
last name: Rosa Baños Rivera, PhD
phone: +34 96 386 44 12
email: Rosa.Banos@uv.es
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
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responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Rosa María Baños Rivera
investigator title: Full professor
sharing ipd: Undecided