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The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

This study has been completed.
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: August 24, 2012
Last updated: April 13, 2015
Last verified: August 2013

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 Intervention
Breast Cancer
Chronic Pain
Other: Mindfulness-Based Cognitive Therapy
Other: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Pain [ Time Frame: From baseline until 6 months ]

    Revised McGill Pain Questionnaire Short Form

    VAS: pain interference

    Additional items: Pain descriptors

Secondary Outcome Measures:
  • 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

Other Outcome Measures:
  • Attachment orientation [ Time Frame: Baseline ]
    the Experiences in Close Relationships Short Version

  • Alexithymia [ Time Frame: From baseline until 6 months ]
    the Toronto Alexithymia Scale

Enrollment: 130
Study Start Date: September 2012
Study Completion Date: January 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Waitlist
Waitlist: participants are offered the intervention (MBCT) after the completion of the main study


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A timeframe of >3 months from surgery, radiation- and chemotherapy and a minimum score of >3 on a pain scale from 0-10 corresponding to moderate pain

Exclusion Criteria:

  • Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand Danish, and chronic pain otherwise associated with the musculoskeletal system
  Contacts and Locations
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Please refer to this study by its identifier: NCT01674881

Aarhus University and Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
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
  More Information

Responsible Party: University of Aarhus Identifier: NCT01674881     History of Changes
Other Study ID Numbers: EPoS-1
Study First Received: August 24, 2012
Last Updated: April 13, 2015

Keywords provided by University of Aarhus:
breast cancer
chronic pain
Breast cancer survivors
Effectiveness of MBCT on chronic pain
Potential mediators and moderators
Effectiveness of MBCT on psychological symptoms

Additional relevant MeSH terms:
Breast Neoplasms
Chronic Pain
Neoplasms by Site
Breast Diseases
Skin Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 27, 2017