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Cognitively-Based Compassion Training for Breast Cancer Survivors (CBCT-BC)

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ClinicalTrials.gov Identifier: NCT03305952
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rosa María Baños Rivera, University of Valencia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Compassion Treatment as Usual Behavioral: CBCT Other: TAU Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : January 11, 2016
Estimated Primary Completion Date : July 18, 2018
Estimated Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Compassion
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
Behavioral: CBCT
Active Comparator: Treatment as usual
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.
Other: TAU



Primary Outcome Measures :
  1. Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) [ Time Frame: 8 weeks, 6 months ]
    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)


Secondary Outcome Measures :
  1. Change Brief Symptom Inventory [BSI-18] [ Time Frame: 8 weeks, 6 months ]
    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)

  2. Change Self-Compassion Scale-Short Form (SCS-SF) [ Time Frame: 8 weeks, 6 months ]
    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)

  3. Change in The Compassion Scale (CS) [ Time Frame: 8 weeks, 6 months ]
    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)

  4. Change in Five Facets of Mindfulness Questionnaire - short form (FFMQ-SF) [ Time Frame: 8 weeks, 6 months ]
    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).

  5. Change in Fear of Cancer Recurrence Inventory (FCRI) [ Time Frame: 8 weeks to six months ]
    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).


Other Outcome Measures:
  1. High attendance (6 sessions) with protocol (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  2. High minutes of home practice (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  3. High percentage of home practice with recordings (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  4. High frequency of practice between sessions (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  5. High percentage of intention to attend to future CBCT® Program courses (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  6. High recommendation rate of CBCT® Program courses (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  7. High satisfaction rate with CBCT® Program instructor's performance (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.

  8. High intention rate to continue with daily practice at home (CBCT® Evaluation Survey) [ Time Frame: 8 weeks ]
    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.



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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being aged between 35 and 75 years,
  • Being able to read and write using the Spanish language,
  • History of treated Breast Cancer within the past 15 years,
  • Free from oncological illness
  • Not receiving any kind of chemotherapy and / or radiotherapy treatment during study.

Eligible participants were contacted by their personal psychooncologist either by a telephone call or at psychooncology appointment periodical visit to invite them to an explanatory meeting of the study.

Exclusion Criteria:

  • Active severe mental disorders (schizophrenia, bipolar disorder, eating disorders, and major depression),
  • Substance use disorders, cognitive impairment,
  • Impaired medical condition.

Past and current psychiatric and medical history was determined by clinician assessment with the Mini International Neuropsychiatric Interview (MINI) (Lecrubier et al., 1997) Spanish version (Lobo et al., 1999).


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): NCT03305952


Contacts
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Contact: Ausiàs Cebolla Martí, PhD +34 96 386 44 07 ausias.cebolla@uv.es
Contact: Rosa Baños Rivera, PhD +34 96 386 44 12 Rosa.Banos@uv.es

Locations
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Spain
Fundación Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
Contact: Rocio Romero Retes, PhD    0034 96 111 43 17    rromero@fivo.org   
Contact: Edgar González Hernández    0034 63 640 55 61    info@mentivida.com   
Sponsors and Collaborators
University of Valencia
Investigators
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Principal Investigator: Edgar Gonzalez-Hernandez Universitat de València
Principal Investigator: Rebeca Diego Pedro, PhD Universitat de València
Principal Investigator: Rocío Romero Retes, PhD Fundación Instituto Valenciano de Oncología
Principal Investigator: Daniel Campos Bacas, PhD Universitat Jaume I
Principal Investigator: Lobsang Tenzin Negi aka Satya Dev Negi, PhD Emory University / Emory-Tibet Partnership
Principal Investigator: Diana Burichka Universitat de València

Additional Information:
Publications of Results:
Other Publications:
Rosenfeld, B., Krivo, S., Breitbart, W., & Chochinov, H. M. (2000). Suicide, assisted suicide, and euthanasia in the terminally ill.
Negi, L. T. (2103). Emory compassion meditation protocol: Cognitively-based compassion training manualemory compassion meditation protocol: Cognitively-based compassion training manual. Atlanta: Emory University.
Moorey, S., Greer, S., & Greer, S. (2002). Cognitive behaviour therapy for people with cancer Oxford University Press Oxford.
Moorey, S. (2007). Breast cancer and body image. The Female Body in Mind: The Interface between the Female Body and Mental Health, , 72.
Jennings, P. A., Foltz, C., Snowberg, K. E., Sim, H., & Kemeny, M. E. (2011). The influence of mindfulness and emotion skills training on teachers' classrooms: The effects of the cultivating emotional balance training. Online Submission,
Gilbert, P. (2010). An introduction to the theory & practice of compassion focused therapy and compassionate mind training for shame based difficulties. Retrieved
García-Campayo, J., Navarro-Gil, M., & Demarzo, M. (2016). Attachment-based compassion therapy. Mindfulness & Compassion,
García-Campayo, J., Cebolla, A., & Demarzo, M. (2016). La ciencia de la compasión (1ª ed.). Madrid: Alianza.
Buick, D. L., Petrie, K. J., Booth, R., Probert, J., Benjamin, C., & Harvey, V. (2000). Emotional and functional impact of radiotherapy and chemotherapy on patients with primary breast cancer. Journal of Psychosocial Oncology, 18(1), 39-62.
Bellver, A., Sánchez-Cánovas, J., Santaballa, A., Munárriz, B., Pérez-Fidalgo, J. A., & Montalar, J. (2009). Mujeres con cáncer de mama: Evaluación del afecto positivo y negativo y valoración de un programa de intervención psicológica en el ámbito hospitalario. Psicooncología, 6(1), 139.
Bartley, T. (2011). Mindfulness-based cognitive therapy for cancer John Wiley & Sons.
Baer, R. A., Lykins, E. L., & Peters, J. R. (2012). Mindfulness and self-compassion as predictors of psychological wellbeing in long-term meditators and matched nonmeditators. The Journal of Positive Psychology, 7(3), 230-238.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rosa María Baños Rivera, Full professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03305952     History of Changes
Other Study ID Numbers: CBCT-IVO
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided