Clinical trial NCT02758197: Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Painful Neuropathy
Chronic Pain
Worries; Pain or Disability
Keywords: Mindfulness
Chronic Pain
Quality of Life
Immune Function
Cancer survivors
Disability
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2016-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month post-intervention.
timeFrame: Baseline and 3 months post-intervention
Secondary outcomes:
measure: Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in quality of life, as measured by the Functional Assessment of Cancer Therapy - General, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in fatigue, as measured by the Brief Fatigue Inventory, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: Change from baseline in fear of cancer recurrence, as measured by the Fear of Cancer Recurrence Inventory, at 3 months post-intervention.
timeFrame: Baseline and 3 months post-intervention
measure: 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.
timeFrame: Baseline and 3 months post-intervention
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Patricia Poulin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: