Compassion Clinical Trial
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.
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.
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