The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Chronic Pain

Intervention / Treatment
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* Other: Mindfulness-Based Cognitive Therapy
* Other: Waitlist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-Based Cognitive Therapy (MBCT)<br>This group will receive MBCT for 8 consecutive weeks. | Other: Mindfulness-Based Cognitive Therapy<br>* 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.<br>|
| Other: Waitlist control group<br>This group is a waitlist control group. | Other: Waitlist<br>* Waitlist: participants are offered the intervention (MBCT) after the completion of the main study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Revised McGill Pain Questionnaire Short Form VAS: pain interference Additional items: Pain descriptors | From baseline until 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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