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The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01674881
Enrollment
130
Registered
2012-08-29
Start date
2012-09-30
Completion date
2015-01-31
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERMindfulness-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.

OTHERWaitlist

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

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PainFrom baseline until 6 monthsRevised McGill Pain Questionnaire Short Form VAS: pain interference Additional items: Pain descriptors

Secondary

MeasureTime frameDescription
MindfulnessFrom baseline until 6 monthsThe Five Facet Mindfulness Questionnaire
Self compassionFrom baseline until 6 monthsthe Self Compassion Scale Short Form
Pain CatastrophizingFrom baseline until 6 monthsthe Pain Catastrophizing Scale
Depression and anxietyFrom baseline until 6 monthsthe Hospital Anxiety and Depression Scale
Well-beingFrom baseline until 6 monthsthe WHO-5

Other

MeasureTime frameDescription
Attachment orientationBaselinethe Experiences in Close Relationships Short Version
AlexithymiaFrom baseline until 6 monthsthe Toronto Alexithymia Scale

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026