The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01674881
First received: August 24, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

    Revised McGill Pain Questionnaire Short Form

    VAS: pain interference

    Additional items: Pain descriptors



Secondary Outcome Measures:
  • Mindfulness [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    The Five Facet Mindfulness Questionnaire

  • Self compassion [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    the Self Compassion Scale Short Form

  • Pain Catastrophizing [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    the Pain Catastrophizing Scale

  • Depression and anxiety [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    the Hospital Anxiety and Depression Scale

  • Well-being [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    the WHO-5


Other Outcome Measures:
  • Attachment orientation [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    the Experiences in Close Relationships Short Version

  • Alexithymia [ Time Frame: From baseline until 6 months ] [ Designated as safety issue: No ]
    the Toronto Alexithymia Scale


Estimated Enrollment: 170
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674881

Contacts
Contact: Maja Johannsen, PhD fellow, MSc psychology 004587165956 majajo@psy.au.dk
Contact: Ea Falk Thostrup, Secretary 004587162674 ea.thostrup@aarhus.rm.dk

Locations
Denmark
Aarhus University and Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Ea Falk Thostrup, Secretary    004587162674    ea.thostrup@aarhus.rm.dk   
Principal Investigator: Maja Johannsen, PhD fellow, MSc Psychology         
Principal Investigator: Robert Zachariae, Professor, MDSci., MSc.         
Sponsors and Collaborators
University of Aarhus
Investigators
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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01674881     History of Changes
Other Study ID Numbers: EPoS-1
Study First Received: August 24, 2012
Last Updated: August 5, 2013
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Mindfulness
breast cancer
chronic pain
mediators
distress
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
Neoplasms
Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 27, 2014