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The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

Primary Purpose

Breast Cancer, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy
Waitlist
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University and Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mindfulness-Based Cognitive Therapy (MBCT)

Waitlist control group

Arm Description

This group will receive MBCT for 8 consecutive weeks.

This group is a waitlist control group.

Outcomes

Primary Outcome Measures

Pain
Revised McGill Pain Questionnaire Short Form VAS: pain interference Additional items: Pain descriptors

Secondary Outcome Measures

Mindfulness
The Five Facet Mindfulness Questionnaire
Self compassion
the Self Compassion Scale Short Form
Pain Catastrophizing
the Pain Catastrophizing Scale
Depression and anxiety
the Hospital Anxiety and Depression Scale
Well-being
the WHO-5

Full Information

First Posted
August 24, 2012
Last Updated
April 13, 2015
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01674881
Brief Title
The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors
Official Title
A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Chronic Pain
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Cognitive Therapy (MBCT)
Arm Type
Experimental
Arm Description
This group will receive MBCT for 8 consecutive weeks.
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
This group is a waitlist control group.
Intervention Type
Other
Intervention Name(s)
Mindfulness-Based Cognitive Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Waitlist
Intervention Description
Waitlist: participants are offered the intervention (MBCT) after the completion of the main study
Primary Outcome Measure Information:
Title
Pain
Description
Revised McGill Pain Questionnaire Short Form VAS: pain interference Additional items: Pain descriptors
Time Frame
From baseline until 6 months
Secondary Outcome Measure Information:
Title
Mindfulness
Description
The Five Facet Mindfulness Questionnaire
Time Frame
From baseline until 6 months
Title
Self compassion
Description
the Self Compassion Scale Short Form
Time Frame
From baseline until 6 months
Title
Pain Catastrophizing
Description
the Pain Catastrophizing Scale
Time Frame
From baseline until 6 months
Title
Depression and anxiety
Description
the Hospital Anxiety and Depression Scale
Time Frame
From baseline until 6 months
Title
Well-being
Description
the WHO-5
Time Frame
From baseline until 6 months
Other Pre-specified Outcome Measures:
Title
Attachment orientation
Description
the Experiences in Close Relationships Short Version
Time Frame
Baseline
Title
Alexithymia
Description
the Toronto Alexithymia Scale
Time Frame
From baseline until 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maja Johannsen, PhD-fellow, MSc psychology
Organizational Affiliation
Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Zachariae, Professor, MDSci., MSc
Organizational Affiliation
Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University and Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27325850
Citation
Johannsen M, O'Connor M, O'Toole MS, Jensen AB, Hojris I, Zachariae R. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Oct 1;34(28):3390-9. doi: 10.1200/JCO.2015.65.0770. Epub 2016 Jun 20.
Results Reference
derived

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The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

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