Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain (COMPASSION)

Ottawa Hospital Research Institute

Status: Completed

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

Treatments: Behavioral: Mindfulness-Based Stress Reduction (MBSR)

Study type: Interventional

Funder types: Other

Identifiers

NCT02758197

20160164-01H

Details and patient eligibility

About

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.

Full description

Chronic neuropathic pain (CNP) affects close to 50% of cancer survivors. Even with the best medical treatment, some survivors continue to experience disabling pain. In our recent survey with cancer survivors, we found that the capacity to be aware of different aspects of one's day-to-day experiences, without judgment or reactivity (i.e., being mindful) predicted decreased pain intensity, pain related disability, and increased health-related quality of life among cancer survivors with CNP. Building on these findings, the present randomized controlled trial will evaluate the effectiveness of an online Mindfulness-Based Stress Reduction (MBSR) program for cancer survivors with moderate to severe CNP. The program will benefit patients in rural and remote regions and patients with mobility issues.

We will recruit 100 cancer survivors. All will have their medical treatment optimized by a pain specialist. Additionally, they will complete an 8-week online MBSR program. We hypothesize that the online MBSR program will result in less pain perception, better function and increased health-related quality of life. We will also examine the effects of the MBSR training on biomarkers of stress and immune function.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 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 (MBSR)

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.