Cognitively-Based Compassion Training for Breast Cancer Survivors

Compassion Clinical Trial

— CBCT-BC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03305952
• Other study ID #: CBCT-IVO
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 8, 2017
• Start date: January 11, 2016
• Est. completion date: July 18, 2018

Study information

• Verified date: October 2017
• Source: University of Valencia
• Contact: Ausiàs Cebolla Martí, PhD
• Phone: +34 96 386 44 07
• Email: ausias.cebolla[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Compassion
• Treatment as Usual

Intervention

Behavioral:
• CBCT

Other:
• TAU

Locations

Country	Name	City	State
Spain	Fundación Instituto Valenciano de Oncología	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	High attendance (6 sessions) with protocol (CBCT® Evaluation Survey)	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 weeks
Other	High minutes of home practice (CBCT® Evaluation Survey)	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 weeks
Other	High percentage of home practice with recordings (CBCT® Evaluation Survey)	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 weeks
Other	High frequency of practice between sessions (CBCT® Evaluation Survey)	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 weeks
Other	High percentage of intention to attend to future CBCT® Program courses (CBCT® Evaluation Survey)	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 weeks
Other	High recommendation rate of CBCT® Program courses (CBCT® Evaluation Survey)	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 weeks
Other	High satisfaction rate with CBCT® Program instructor's performance (CBCT® Evaluation Survey)	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 weeks
Other	High intention rate to continue with daily practice at home (CBCT® Evaluation Survey)	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 weeks
Primary	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)	8 weeks, 6 months
Secondary	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)	8 weeks, 6 months
Secondary	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)	8 weeks, 6 months
Secondary	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)	8 weeks, 6 months
Secondary	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).	8 weeks, 6 months
Secondary	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).	8 weeks to six months

External Links

•   Weiss, M. C. (2017). U.S. breast cancer statistics.