The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

NCT01674881 | Completed

• 1 other identifier: EPoS-1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Pain

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

  From baseline until 6 months

Secondary Outcomes (5)

• Mindfulness

  From baseline until 6 months

• Self compassion

  From baseline until 6 months

• Pain Catastrophizing

  From baseline until 6 months

• Depression and anxiety

  From baseline until 6 months

• Well-being

  From baseline until 6 months

Other Outcomes (2)

• Attachment orientation

  Baseline

• Alexithymia

  From baseline until 6 months

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

This group will receive MBCT for 8 consecutive weeks.

Other: Mindfulness-Based Cognitive Therapy

Waitlist control group

OTHER

This group is a waitlist control group.

Other: Waitlist

Interventions

Mindfulness-Based Cognitive Therapy OTHER

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.

Mindfulness-Based Cognitive Therapy (MBCT)

Waitlist OTHER

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

Waitlist control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University and Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 27325850 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Chronic Pain

Interventions

Mindfulness-Based Cognitive Therapy; Waiting Lists

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: August 29, 2012
• Study Start: September 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2013-08

Locations

DK (1)