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OpenTrials
Completed

NCT Number: NCT01674881

The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University and Aarhus University Hospital

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Waitlist

Other

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

Primary outcomes

  1. Pain

    Time frame: From baseline until 6 months

    Revised McGill Pain Questionnaire Short Form

    VAS: pain interference

    Additional items: Pain descriptors

Secondary outcomes

  1. Mindfulness

    Time frame: From baseline until 6 months

    The Five Facet Mindfulness Questionnaire

  2. Self compassion

    Time frame: From baseline until 6 months

    the Self Compassion Scale Short Form

  3. Pain Catastrophizing

    Time frame: From baseline until 6 months

    the Pain Catastrophizing Scale

  4. Depression and anxiety

    Time frame: From baseline until 6 months

    the Hospital Anxiety and Depression Scale

  5. Well-being

    Time frame: From baseline until 6 months

    the WHO-5

Other outcomes

  1. Attachment orientation

    Time frame: Baseline

    the Experiences in Close Relationships Short Version

  2. Alexithymia

    Time frame: From baseline until 6 months

    the Toronto Alexithymia Scale

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Aug 29, 2012
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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