Clinical trial NCT01674881: The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors
Official title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain
timeFrame: From baseline until 6 months
Secondary outcomes:
measure: Mindfulness
timeFrame: From baseline until 6 months
measure: Self compassion
timeFrame: From baseline until 6 months
measure: Pain Catastrophizing
timeFrame: From baseline until 6 months
measure: Depression and anxiety
timeFrame: From baseline until 6 months
measure: Well-being
timeFrame: From baseline until 6 months
Other outcomes:
measure: Attachment orientation
timeFrame: Baseline
measure: Alexithymia
timeFrame: From baseline until 6 months
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University and Aarhus University Hospital
Study officials:
affiliation: Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital
name: Maja Johannsen, PhD-fellow, MSc psychology
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University
name: Robert Zachariae, Professor, MDSci., MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.