The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer; Chronic Pain
• Interventions: Other: Mindfulness-Based Cognitive Therapy; Other: Waitlist

• Registration Number: NCT01674881
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-29
• Study Start: 2012-09
• Status Verified: 2013-08
• Primary Completion: 2014-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-Based Cognitive Therapy (MBCT)	Mindfulness-Based Cognitive Therapy	This group will receive MBCT for 8 consecutive weeks.
Waitlist control group	Waitlist	This group is a waitlist control group.

Primary Outcome Measures

Name	Time	Method
Pain	From baseline until 6 months	Revised McGill Pain Questionnaire Short Form; VAS: pain interference; Additional items: Pain descriptors

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aarhus University and Aarhus University Hospital; 🇩🇰 Aarhus, Denmark