Overview

This trial is active, not recruiting.

Conditions breast cancer, painful neuropathy, chronic pain, worries; pain or disability, quality of life
Treatment mindfulness-based stress reduction
Sponsor Ottawa Hospital Research Institute
Collaborator Canadian Breast Cancer Foundation
Start date October 2013
End date October 2016
Trial size 110 participants
Trial identifier NCT02125006, 20130525-01H

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.

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) program following medical treatment optimization. The MBSR program will be composed of eight weekly 2.5 hour sessions and one 6 hour session midway through the course.
mindfulness-based stress reduction
Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups. To assess therapist adherence to the protocol, sessions will be recorded. A random selection of 50% of sessions will be rated by an MBSR trainer who completed the University of Massachusetts Centre for Mindfulness in Medicine, Health Care and Society Teacher Development Intensive using a checklist of specified treatment components. A percentage score for each session rated will be calculated to determine therapist adherence.
(No Intervention)
Participants assigned to this group after medical treatment optimization will act as wait-list controls for the MBSR group. They will be enrolled in the MBSR workshop 3 months after the corresponding intervention group completes the program.

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.
time frame: 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
time frame: Baseline and 3 months post-intervention
Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention
time frame: Baseline and 3 months post-intervention
Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention
time frame: Baseline and 3 months post-intervention
Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention
time frame: Baseline and 3 months post-intervention
Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention
time frame: Baseline and 3 months post-intervention
Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention
time frame: Baseline and 3 months post-intervention
Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention.
time frame: Baseline and 3 months post-intervention
Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.
time frame: Baseline and 3 months post-intervention
Change from baseline in quality of life, as measured by the Short-Form-12 Health Survey, at 3 months post-intervention.
time frame: Baseline and 3 months post-intervention
Change from pre-intervention in biomarkers of stress, as measured by hair cortisol levels, at 3 months post-intervention.
time frame: Pre-intervention and 3 months post-intervention
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.
time frame: Baseline and 3 months post-intervention
Change from baseline in biomarkers of stress, as measured by telomere length, at 3 months post-intervention.
time frame: Baseline and 3 months post-intervention
Change from pre-intervention in neuronal health, as measured by white matter integrity, at 2 weeks post-intervention.
time frame: Pre-intervention and 2 weeks post-intervention
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.
time frame: Pre-intervention and 2 weeks post-intervention
Change from pre-intervention in brain structure, as measured by changes in structural volume different areas of the brain, at 2 weeks post-intervention.
time frame: Pre-intervention and 2 weeks post-intervention

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Patricia Poulin, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.