NCT03305952 — Cognitively-Based Compassion Training for Breast Cancer Survivors · CancerIndex
Clinical trial · Interventional
Cognitively-Based Compassion Training for Breast Cancer Survivors
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.
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Condition (as posted)
Mapped entity
Match
Confidence
Compassion
—
UNRESOLVED
—
Treatment as Usual
—
UNRESOLVED
—
Interventions
Interventions (2)
Intervention
Type
Mapped drug
Match
CBCT
Behavioral
—
UNRESOLVED
TAU
Other
—
UNRESOLVED
Design
Arms and outcomes
Arms (2)
type
EXPERIMENTAL
label
Compassion
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
interventionNames
Behavioral: CBCT
type
ACTIVE_COMPARATOR
label
Treatment as usual
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.
interventionNames
Eligibility
Eligibility (as posted)
Sex
All
Minimum age
25 Years
Maximum age
75 Years
Show eligibility criteria text
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).
References
Publications (38)
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Other: TAU
Primary outcomes (1)
measure
Change in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B+4)
timeFrame
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)
Secondary outcomes (5)
measure
Change Brief Symptom Inventory [BSI-18]
timeFrame
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)
timeFrame
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)
timeFrame
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)
timeFrame
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)
timeFrame
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).
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RESULTThewes B, Butow P, Bell ML, Beith J, Stuart-Harris R, Grossi M, Capp A, Dalley D; FCR Study Advisory Committee. Fear of cancer recurrence in young women with a history of early-stage breast cancer: a cross-sectional study of prevalence and association with health behaviours. Support Care Cancer. 2012 Nov;20(11):2651-9. doi: 10.1007/s00520-011-1371-x. Epub 2012 Feb 11. PMID 22328003
RESULTThewes B, Brebach R, Dzidowska M, Rhodes P, Sharpe L, Butow P. Current approaches to managing fear of cancer recurrence; a descriptive survey of psychosocial and clinical health professionals. Psychooncology. 2014 Apr;23(4):390-6. doi: 10.1002/pon.3423. Epub 2013 Nov 1. PMID 24307136
RESULTSiegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7. PMID 26742998
RESULTSansó, N., Galiana, L., Cebolla, A., Oliver, A., Benito, E., & Ekman, E. (2017). Cultivating emotional balance in professional caregivers: A pilot intervention. Mindfulness, , 1-9.
DERIVEDGonzalez-Hernandez E, Romero R, Campos D, Burychka D, Diego-Pedro R, Banos R, Negi LT, Cebolla A. Cognitively-Based Compassion Training (CBCT(R)) in Breast Cancer Survivors: A Randomized Clinical Trial Study. Integr Cancer Ther. 2018 Sep;17(3):684-696. doi: 10.1177/1534735418772095. Epub 2018 Apr 22. PMID 29681185