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CompassionCBCT-BCNCT03305952

Cognitively-Based Compassion Training for Breast Cancer Survivors

A study testing CBCT and TAU in people with Compassion and Treatment as Usual, run by University of Valencia at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Compassion, Treatment as Usual
What is being tested?
CBCT and TAU
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteSpain
Study dates
11 Jan 2016to 18 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Ausiàs Cebolla Martí, PhD contact

+34 96 386 44 07

ausias.cebolla@uv.es

Rosa Baños Rivera, PhD contact

+34 96 386 44 12

Rosa.Banos@uv.es

Spain1 site, 1 recruiting
  • Fundación Instituto Valenciano de Oncología

    Valencia, 46009

    Rocio Romero Retes, PhD, 0034 96 111 43 17, rromero@fivo.org

    Edgar González Hernández, 0034 63 640 55 61, info@mentivida.com

    Recruiting

Other trials in Spain

About this study

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

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.

Read more

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.

Read the detailed description

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.

Being tested
CBCT, TAU

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBCTBehavioural

  • TAUOther

Study groups in NCT03305952
Study groupRoleWhat they receive
CompassionExperimentalCBCT 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
Receives: Behavioral: CBCT
Treatment as usualActive comparatorTreatment 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.
Receives: Other: TAU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4)

    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)

    Measured: 8 weeks, 6 months

Secondary outcomes (5)
  1. Change Brief Symptom Inventory [BSI-18]

    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)

    Measured: 8 weeks, 6 months

  2. Change Self-Compassion Scale-Short Form (SCS-SF)

    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)

    Measured: 8 weeks, 6 months

  3. Change in The Compassion Scale (CS)

    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)

    Measured: 8 weeks, 6 months

  4. Change in Five Facets of Mindfulness Questionnaire - short form (FFMQ-SF)

    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).

    Measured: 8 weeks, 6 months

  5. Change in Fear of Cancer Recurrence Inventory (FCRI)

    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).

    Measured: 8 weeks to six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2017
  2. Study start11 Jan 2016
  3. Primary completion18 Jul 2018 (estimated)
  4. Study completion18 Jul 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03305952
Sponsor's protocol ID
CBCT-IVO
Acronym
CBCT-BC
Status last verified
Oct 2017
First submitted
2 Oct 2017
Last updated
10 Oct 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 25559415
  • Rosenfeld, B., Krivo, S., Breitbart, W., & Chochinov, H. M. (2000). Suicide, assisted suicide, and euthanasia in the terminally ill.

  • 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.

    PubMed 19273406
  • Pace TW, Negi LT, Dodson-Lavelle B, Ozawa-de Silva B, Reddy SD, Cole SP, Danese A, Craighead LW, Raison CL. Engagement with Cognitively-Based Compassion Training is associated with reduced salivary C-reactive protein from before to after training in foster care program adolescents. Psychoneuroendocrinology. 2013 Feb;38(2):294-9. doi: 10.1016/j.psyneuen.2012.05.019. Epub 2012 Jul 3.

    PubMed 22762896
  • Pace TW, Negi LT, Adame DD, Cole SP, Sivilli TI, Brown TD, Issa MJ, Raison CL. Effect of compassion meditation on neuroendocrine, innate immune and behavioral responses to psychosocial stress. Psychoneuroendocrinology. 2009 Jan;34(1):87-98. doi: 10.1016/j.psyneuen.2008.08.011. Epub 2008 Oct 4.

    PubMed 18835662
  • Negi, L. T. (2103). Emory compassion meditation protocol: Cognitively-based compassion training manualemory compassion meditation protocol: Cognitively-based compassion training manual. Atlanta: Emory University.

  • Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful self-compassion program. J Clin Psychol. 2013 Jan;69(1):28-44. doi: 10.1002/jclp.21923. Epub 2012 Oct 15.

    PubMed 23070875
  • 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.

  • Matthews H, Grunfeld EA, Turner A. The efficacy of interventions to improve psychosocial outcomes following surgical treatment for breast cancer: a systematic review and meta-analysis. Psychooncology. 2017 May;26(5):593-607. doi: 10.1002/pon.4199. Epub 2016 Aug 2.

    PubMed 27333194
  • Kok BE, Coffey KA, Cohn MA, Catalino LI, Vacharkulksemsuk T, Algoe SB, Brantley M, Fredrickson BL. How positive emotions build physical health: perceived positive social connections account for the upward spiral between positive emotions and vagal tone. Psychol Sci. 2013 Jul 1;24(7):1123-32. doi: 10.1177/0956797612470827. Epub 2013 May 6.

    PubMed 23649562
  • 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,

  • Hofmann SG, Grossman P, Hinton DE. Loving-kindness and compassion meditation: potential for psychological interventions. Clin Psychol Rev. 2011 Nov;31(7):1126-32. doi: 10.1016/j.cpr.2011.07.003. Epub 2011 Jul 26.

    PubMed 21840289
  • 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,

Questions about this trial

What is this clinical trial studying?

A study testing CBCT and TAU in people with Compassion and Treatment as Usual, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ausiàs Cebolla Martí, PhD (+34 96 386 44 07, ausias.cebolla@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4) (time frame: 8 weeks, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03305952, which also lists 38 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2017.

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