The Effects of an Online Mindfulness-Based Stress Reduction (MBSR) Program on Quality of Life and Immune Function Among Cancer Survivors With Chronic Neuropathic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Ottawa Hospital Research Institute
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
Time Frame: Baseline and 3 months 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.
Secondary Outcomes
- 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 quality of life, as measured by the Functional Assessment of Cancer Therapy - General, 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 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)
- Change from baseline in fear of cancer recurrence, as measured by the Fear of Cancer Recurrence Inventory, 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)
- Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Change from baseline in immune function, as measured by blood levels of tumor necrosis factor - alpha interleukin-6, interleukin-4, interleukin-10, and c-reactive protein at 3 months post-intervention.(Baseline and 3 months post-intervention)
- Change from baseline in fatigue, as measured by the Brief Fatigue Inventory, at 3 months post-intervention.(Baseline and 3 months post-intervention)