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

NCT02125006 | Completed

• 1 other identifier: 20130525-01H
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.

  The primary outcome is pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale. The Brief Pain Inventory (BPI) - Pain Interference consists of 7 numerical scales (0 to 10) rating pain interference with general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life.

  Baseline and 3 months post-intervention

Secondary Outcomes (15)

• Change from baseline in neuropathic pain intensity, as measured by the Neuropathic Pain Symptom Inventory, at 3 months post-intervention

  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

  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

  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

  Baseline and 3 months post-intervention

• Change from baseline in stress, as measured by the Perceived Stress Scale, at 3 months post-intervention

  Baseline and 3 months post-intervention

Study Arms (2)

Interdisciplinary program including MBSR

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.

Behavioral: Mindfulness-Based Stress Reduction

Wait-listed Control Group

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.

Interventions

Mindfulness-Based Stress Reduction 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.

Interdisciplinary program including MBSR

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Breast Cancer Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Neuropathy, Painful; Chronic Pain; Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Patricia Poulin, PhD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: August 1, 2018
• Last Updated: July 23, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)