The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

April 13, 2015 updated by: University of Aarhus

A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University and Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: From baseline until 6 months

Revised McGill Pain Questionnaire Short Form

VAS: pain interference

Additional items: Pain descriptors
From baseline until 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mindfulness
Time Frame: From baseline until 6 months
The Five Facet Mindfulness Questionnaire
From baseline until 6 months
Self compassion
Time Frame: From baseline until 6 months
the Self Compassion Scale Short Form
From baseline until 6 months
Pain Catastrophizing
Time Frame: From baseline until 6 months
the Pain Catastrophizing Scale
From baseline until 6 months
Depression and anxiety
Time Frame: From baseline until 6 months
the Hospital Anxiety and Depression Scale
From baseline until 6 months
Well-being
Time Frame: From baseline until 6 months
the WHO-5
From baseline until 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attachment orientation
Time Frame: Baseline
the Experiences in Close Relationships Short Version
Baseline
Alexithymia
Time Frame: From baseline until 6 months
the Toronto Alexithymia Scale
From baseline until 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPoS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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