The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01674881|
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : April 14, 2015
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.
Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.
The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.
The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Chronic Pain||Other: Mindfulness-Based Cognitive Therapy Other: Waitlist||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2015|
Experimental: Mindfulness-Based Cognitive Therapy (MBCT)
This group will receive MBCT for 8 consecutive weeks.
Other: Mindfulness-Based Cognitive Therapy
MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).
Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD.
Waitlist control group
This group is a waitlist control group.
Waitlist: participants are offered the intervention (MBCT) after the completion of the main study
- Pain [ Time Frame: From baseline until 6 months ]
Revised McGill Pain Questionnaire Short Form
VAS: pain interference
Additional items: Pain descriptors
- Mindfulness [ Time Frame: From baseline until 6 months ]The Five Facet Mindfulness Questionnaire
- Self compassion [ Time Frame: From baseline until 6 months ]the Self Compassion Scale Short Form
- Pain Catastrophizing [ Time Frame: From baseline until 6 months ]the Pain Catastrophizing Scale
- Depression and anxiety [ Time Frame: From baseline until 6 months ]the Hospital Anxiety and Depression Scale
- Well-being [ Time Frame: From baseline until 6 months ]the WHO-5
- Attachment orientation [ Time Frame: Baseline ]the Experiences in Close Relationships Short Version
- Alexithymia [ Time Frame: From baseline until 6 months ]the Toronto Alexithymia Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01674881
|Aarhus University and Aarhus University Hospital|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Maja Johannsen, PhD-fellow, MSc psychology||Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital|
|Principal Investigator:||Robert Zachariae, Professor, MDSci., MSc||Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University|