Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain

NCT02758197 | Completed

• 1 other identifier: 20160164-01H
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will evaluate the effectiveness of an interdisciplinary treatment approach combining medical management with an online Mindfulness-Based Stress Reduction (MBSR) program in reducing disability and improving quality of life among cancer survivors living with moderate to severe chronic neuropathic pain.

Conditions

Cancer; Painful Neuropathy; Chronic Pain; Worries; Pain or Disability

Keywords

Mindfulness; Chronic Pain; Quality of Life; Immune Function; Cancer survivors; Disability

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 (10)

• 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 depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention

  Baseline and 3 months post-intervention

• Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing 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 (MBSR)

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 (MBSR) BEHAVIORAL

Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) course directly following medical treatment optimization. The MBSR course consists of eight weekly 2-hour sessions and one 6 hour session midway through the course and involves psychoeducation, relaxation techniques, gentle stretching (very mild form of yoga), and different forms of meditation. Participants will learn ways to better cope with their pain and the disability and distress related to it with a goal of reducing the stress response that is our body's normal reaction to pain. All sessions will be conducted by a psychologist or social worker with a minimum of 2 years of experience in chronic pain management, formal MBSR training and 2 years of experience leading MBSR groups.

Also known as: MBSR

Interdisciplinary program including MBSR

Eligibility Criteria

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

You may qualify if:

• cancer survivors
• experiencing cancer-related neuropathic pain symptoms for at least 3 months
• pain severity ≥4/10 (moderate to severe)
• ability to attend 7 out of 9 MBSR sessions
• ability to complete questionnaires and attend sessions conducted in English or French
• access to the internet and use of an electronic device capable of joining a video conference (i.e., computer or mobile device with a camera and microphone)

You may not qualify if:

• expected survival of less than 12 months
• cognitive impairment
• severe psychiatric disorder impacting ability to participate (e.g., schizophrenia, severe depression)
• prior experience with MBSR

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Cancer Society (CCS): collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Neoplasms; Neuropathy, Painful; Chronic Pain; Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

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, Ph.D

  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 28, 2016
• First Posted: May 2, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)