The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01674881
• Other study ID #: EPoS-1
• Status: Completed
• Phase: N/A
• First received: August 24, 2012
• Last updated: April 13, 2015
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Chronic Pain

Intervention

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
Waitlist: participants are offered the intervention (MBCT) after the completion of the main study

Locations

Country	Name	City	State
Denmark	Aarhus University and Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attachment orientation	the Experiences in Close Relationships Short Version	Baseline	No
Other	Alexithymia	the Toronto Alexithymia Scale	From baseline until 6 months	No
Primary	Pain	Revised McGill Pain Questionnaire Short Form; VAS: pain interference; Additional items: Pain descriptors	From baseline until 6 months	No
Secondary	Mindfulness	The Five Facet Mindfulness Questionnaire	From baseline until 6 months	No
Secondary	Self compassion	the Self Compassion Scale Short Form	From baseline until 6 months	No
Secondary	Pain Catastrophizing	the Pain Catastrophizing Scale	From baseline until 6 months	No
Secondary	Depression and anxiety	the Hospital Anxiety and Depression Scale	From baseline until 6 months	No
Secondary	Well-being	the WHO-5	From baseline until 6 months	No