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Hydrocortisone

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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.

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.

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.

Mindfulness-Based Stress Reduction

Patricia Poulin, PhD

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.

The investigators will recruit 108 adult women survivors of breast cancer living with chronic neuropathic pain. All will have their medical treatment optimized by a pain medicine specialist before being randomly assigned to either an 8-week group MBSR program or a wait-list. All participants will complete self-report questionnaires, provide a hair sample for cortisol measurements and a blood sample to measure several markers of immune function at four different time points: before medical treatment, after medical treatment and before randomization to MBSR or waiting, after the completion of MBSR as well as at 3-month follow-up. A sub-sample will complete a series of tasks while undergoing functional magnetic resonance imaging before and after participation in MBSR.

The primary outcome is pain interference. The investigators will compare the proportion of participants who report reduced pain-related disability, as measured by the Brief Pain Inventory-Interference Scale, in each group. The primary hypothesis is that at 3-month follow-up, there will be at least 30% more responders (≥1.0 decrease in mean Brief Pain Inventory Interference score) in the interdisciplinary program in comparison to medical treatment alone.

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

The Effect of an Inter-Disciplinary Program, Including Mindfulness-Based Stress Reduction, on Psychosocial Function, Pain Perception, Disability and Quality of Life in Breast Cancer Survivors With Chronic Neuropathic Pain

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.

Neuropathic pain intensity will be measured using the Neuropathic Pain Symptom Inventory (NPSI), a self-report questionnaire that consists of 10 pain descriptors and two temporal items. Responses are rated on a numerical scale (0-10) and a total intensity score is calculated. Five sub-scores are also derived: spontaneous burning pain, spontaneous pressing pain, paroxysmal pain, evoked pain and paresthesia/dysesthesia.

Pain Severity will be measured using the Brief Pain Inventory (BPI) - Pain Severity. The BPI consists of 4 numerical scales (0 to 10) rating pain severity at its worst, at its least, on average, and at the time of filling out the measure. Each severity question is analyzed individually.

The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale ( 0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 subscales: depression, tension-anxiety, anger-hostility, vigor-activity, fatigue, confusion-bewilderment.

The participants' perceived degree of change in overall status will be measured using the Patient Global Impression of Change (PGIC) scale. The PGIC uses a 7-point likert scale (very much worse, to very much better) to measure how much the participant feels their overall status has changed since the start of the study.

The Perceived Stress Scale (PSS) will be used to measure the participants' perceived stress levels. The PSS uses a 5-point likert scale (0=Never, to 4=Very often) to measure the degree of stress a participant has experienced over the past month. A total perceived stress score is obtained by reversing the scores on items 4, 5, 7, and 8, and then summing across all 10 items. Higher scores indicate higher perceived stress.

The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item scale used to assess the severity of depressive symptoms over the past two weeks and is based on Diagnostic and Statistical Manual (DSM-IV) diagnostic criteria for major depression. Total scores range from 0 to 27, and clinical cut-points correspond to mild, moderate, moderately severe, and severe depression.

The Pain Catastrophizing Scale (PCS) is a 13-item instrument which will evaluate the degree to which patients have negative self-statements and catastrophizing thoughts and ideations when in pain. The PCS uses a 5-point likert scale (0=not at all, 4=all the time) and consists of three subscales (rumination, magnification, helplessness).

Mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ). The FFMQ is a 39-item instrument measuring five aspects of mindfulness: Non-reactivity to inner experience, observing, describing, acting with awareness, and non-judging of experience. Participants are asked to use a 5-point Likert-type scale (1 = never or rarely true; 5 = very often or always true) to rate how true of them they believe each statement to be.

Quality of life will be measured by the Short-Form-12 Health Survey (SF-12v.2). The SF-12v2 is a brief, twelve-item self-report measure based on the Short-Form-36. It includes items assessing eight health domains, such as bodily pain, social functioning, role limitations due to physical health, and general health perceptions. Two summary scores, the physical composite scale (PCS) and mental composite scale (MCS) are computed based on the 12 items. Scores range from 0 to 100, with higher scores indicating greater quality of life.

Cortisol is a useful biomarker of stress levels. One cm hair samples will allow us to collect data on cortisol exposure over the past month.

Six mL whole blood samples will be obtained from participants and the measurement of cytokine secretion and CRP will be performed. The concentrations of interleukin-4 (IL-4), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor - alpha (TNF-α), as well as C reactive protein (CRP) production will be quantified and recorded. All samples and standards will be analyzed in duplicate.

Total genomic DNA will be extracted from 0.2 mL of whole blood. The relative average Telomere Length (TL) will be determined and recorded. Samples will be analyzed in triplicate.

Changes in participants' neuronal health will be measured with MRI sessions that include diffusion tensor imaging (DTI). These imaging sessions will provide measures of white matter integrity (fractional anisotropy, mean diffusivity, radial diffusivity).

Changes in blood flow to areas of participants' brains known to be associated with emotional regulation will be measured using functional magnetic imaging (fMRI).

High resolution magnetic resonance imaging will be used to look at the anatomy of participants' brains and measure changes in structural volume.

Canadian Breast Cancer Foundation

Canadian Institutes of Health Research (CIHR)

Ottawa Hospital Research Institute

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.

Mindfulness-Based Stress Reduction (MBSR)

Patricia Poulin, Ph.D

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.

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.

Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain

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

The Profile of Mood States (POMS-2A) will be used to measure mood disturbance. Participants are asked to rate 65 adjectives using a 5-point likert scale ( 0= not at all, to 4 = extremely) based on how they have been feeling during the past week, including the day they are filling out the questionnaire. A total mood disturbance score is calculated, as well as scores for 6 sub-scales: depression, tension-anxiety, anger-hostility, vigor-activity, fatigue, confusion-bewilderment.

Quality of life will be measured using the Functional Assessment of Cancer Therapy - General (FACT-G). The FACT-G is a 27-item instrument containing general statements which fall within four domains of quality of life: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Participants are asked to respond to each statement using a 5-point Likert scale from 0 (not at all) to 4 (very much) to indicate how true the statement is for them over the previous seven days.

Fatigue will be measured using the Brief Fatigue Inventory (BFI). The BFI is a 9-item instrument that measures fatigue severity and the impact it has had on participants' day-to-day functioning in the previous 24 hours. Participants are asked to rate their fatigue at the time of completion as well as their average fatigue and worst fatigue over the previous 24 hours on an 11-point Likert scale from 0 (no fatigue) to 10 (as bad as you can imagine), and the degree to which their fatigue has interfered with their general activity, mood, walking ability, normal work, relations with others, and enjoyment of life over the previous 24 hours on an 11-point Likert scale from 0 (does not interfere) to 10 (completely interferes).

Fear of cancer recurrence will be measured using the Fear of Cancer Recurrence Inventory (FCRI). The FCRI is a 42-item instrument that measures seven factors of cancer recurrence: triggers, severity, psychological distress, functional impairment, insight, reassurance, and coping strategies. Participants respond to questions using a 5-point Likert scale from 0 (not at all or never) to 4 (a great deal or all the time). The scale provides a global score as well as seven sub-scale scores; one for each factor. A higher score indicates higher levels of fear of cancer recurrence.

Immune function, with particular attention to the following parameters: tumor necrosis factor - alpha (TNF-α), interleukin-6 (IL-6), interleukin-4 (IL-4), interleukin-10 (IL-10), and c-reactive protein (CRP) will be measured from participant blood samples. Six mL whole blood samples will be obtained from participants and the concentration of these parameters will be quantified and recorded. All samples and standards will be analyzed in duplicate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain	NCT02125006	Breast Cancer Painful Neuropa... Chronic Pain Worries; Pain o... Quality of Life	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute
The Effect of an Inter-Disciplinary Program, Including MBSR, in Breast Cancer Survivors With Chronic Neuropathic Pain	NCT02125006	Breast Cancer Painful Neuropa... Chronic Pain Worries; Pain o... Quality of Life	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute
Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain	NCT02758197	Cancer Painful Neuropa... Chronic Pain Worries; Pain o...	Mindfulness-Bas...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for painful neuropathy