Clinical trial NCT02125006: The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain
Official title: The Effect of an Inter-Disciplinary Program, Including Mindfulness-Based Stress Reduction, on Psychosocial Function, Pain Perception, Disability and Quality of Life in Breast Cancer Survivors With Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Painful Neuropathy
Chronic Pain
Worries; Pain or Disability
Quality of Life
Keywords: Mindfulness
Breast Cancer
Painful Neuropathy
Chronic Pain
fMRI
Disability
Quality of Life
Cytokines
Cortisol
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
name: Canadian Institutes of Health Research (CIHR)
First posted: 2014-04-29
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic neuropathic pain is a common problem for breast cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. It is well-established that an interdisciplinary approach is key to the treatment of some types of chronic pain, but little research has been done on the effectiveness of interdisciplinary treatments for cancer survivors with chronic neuropathic pain. The investigators will evaluate the effectiveness of an interdisciplinary approach combining medical treatment and mindfulness-based stress reduction (MBSR) to reduce disability and improve quality of life among breast cancer survivors with chronic neuropathic pain. The investigators will also evaluate the impact of the program on psychological distress, pain cognitions, biomarkers of stress and immune function, cognitive function, as well as brain structure and function.

Detailed description: The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.

The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.

Eligibility criteria: Inclusion Criteria:

* Female.
* 18 years or older.
* Completed treatment for breast cancer a minimum of 1 year prior to study enrollment.
* Have been experiencing neuropathic pain following their cancer treatment for a minimum of 6 months.
* Report pain intensity levels ≥4 (moderate to severe).

Exclusion Criteria:

* Metastatic disease or current evidence of cancer recurrence
* Pregnancy or breastfeeding
* Unable to complete questionnaires in English or French.

Primary outcomes:
measure: Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Change from baseline in neuropathic pain intensity, as measured by the Neuropathic Pain Symptom Inventory, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in quality of life, as measured by the Short-Form-12 Health Survey, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention.
timeFrame: Pre-intervention and 3 months post-intervention
measure: Change from baseline in immune function, as measured by blood levels of interleukin-4, interleukin-6, interleukin-10, tumor necrosis factor - alpha, and C reactive protein, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in biomarkers of stress, as measured by telomere length, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from pre-intervention in neuronal health, as measured by white matter integrity, at 2 weeks post-intervention.
timeFrame: Pre-intervention and 2 weeks post-intervention
measure: Change from pre-intervention in brain areas associated with emotional regulation, as measured by blood flow in the brain seen in functional magnetic imaging, at 2 weeks post-intervention.
timeFrame: Pre-intervention and 2 weeks post-intervention
measure: Change from pre-intervention in brain structure, as measured by changes in structural volume different areas of the brain, at 2 weeks post-intervention.
timeFrame: Pre-intervention and 2 weeks post-intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Patricia Poulin, PhD
role: PRINCIPAL_INVESTIGATOR
References: