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

Ottawa Hospital Research Institute

Status: Completed

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

Treatments: Behavioral: Mindfulness-Based Stress Reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT02125006

20130525-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

118 participants in 2 patient groups

Interdisciplinary program including MBSR

Experimental group

Description:

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.

Treatment:

Behavioral: Mindfulness-Based Stress Reduction

Wait-listed Control Group

No Intervention group

Description:

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.