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

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ClinicalTrials.gov Identifier: NCT02758197
Recruitment Status : Recruiting
First Posted : May 2, 2016
Last Update Posted : March 2, 2018
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.

Condition or disease Intervention/treatment Phase
Cancer Painful Neuropathy Chronic Pain Worries; Pain or Disability Behavioral: Mindfulness-Based Stress Reduction (MBSR) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : July 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interdisciplinary program including MBSR
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)
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.
Other Name: MBSR

No Intervention: Wait-listed Control Group
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 3 months post-intervention [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  2. Change from baseline in mood states, as measured by the Profile of Mood States scale, at 3 months post-intervention [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  3. Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 3 months post-intervention [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  4. Change from baseline in depressive symptoms, as measured by the Patient Health Questionnaire - 9 scale, at 3 months post-intervention [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  5. Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]
    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).

  6. Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  7. Change from baseline in quality of life, as measured by the Functional Assessment of Cancer Therapy - General, at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  8. Change from baseline in fatigue, as measured by the Brief Fatigue Inventory, at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]
    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).

  9. Change from baseline in fear of cancer recurrence, as measured by the Fear of Cancer Recurrence Inventory, at 3 months post-intervention. [ Time Frame: Baseline and 3 months post-intervention ]
    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.

  10. 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. [ Time Frame: Baseline and 3 months post-intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758197


Contacts
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Contact: Patricia Poulin, PhD 6137378899 ext 73897 ppoulin@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Patricia Poulin, Ph.D         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Patricia Poulin, Ph.D Ottawa Hospital Research Institute

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02758197     History of Changes
Other Study ID Numbers: 20160164-01H
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ottawa Hospital Research Institute:
Mindfulness
Chronic Pain
Quality of Life
Immune Function
Cancer survivors
Disability

Additional relevant MeSH terms:
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Chronic Pain
Neuralgia
Pain
Neurologic Manifestations
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases