The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain

NCT ID: NCT02125006

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2018-08-31

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.

Conditions

Breast Cancer; Painful Neuropathy; Chronic Pain; Worries; Pain or Disability; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Interdisciplinary program including MBSR

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Stress Reduction

Intervention Type: BEHAVIORAL

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.

Wait-listed Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Poulin, PhD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20130525-01H

Identifier Type: -

Identifier Source: org_study_id