Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03305952
Status:
UNKNOWN
Last Update Posted:
2017-10-10
First Post:
2017-10-02
Brief Title:
Cognitively-Based Compassion Training for Breast Cancer Survivors
Sponsor:
University of Valencia
Organization:
University of Valencia
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBCT-BC
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
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
Detailed Description:
About 1 in 8 US women around 12 will develop invasive Breast Cancer BC over the course of hisher lifetime In 2015 there were 231840 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 252710 new cases of invasive BC are expected to be diagnosed in women in the US along with 63410 new cases of non-invasive in situ BC In Spain there are around 21000 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 29 155 and 408 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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None