CancerCOMPASSIONNCT02758197
Online MBSR Program for Cancer Survivors With Chronic Neuropathic Pain
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Cancer and Painful Neuropathy, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Painful Neuropathy, Chronic Pain
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer, Painful Neuropathy, Chronic Pain, Worries; Pain or Disability
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness, Chronic Pain, Quality of Life, Immune Function, Cancer survivors, Disability
- Medical subject headings
- Neoplasms, Neuropathy, Painful, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary program including MBSR | Experimental | 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. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
| Wait-listed Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain-related disability, as measured by the Brief Pain Inventory - Pain Interference scale, at 3-month 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.
Measured: Baseline and 3 months post-intervention
Secondary outcomes (10)
Change from baseline in pain severity, as measured by the Brief Pain Inventory - Pain Severity scale, at 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.
Measured: 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
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.
Measured: Baseline and 3 months post-intervention
Overall change in status from baseline, as measured by Patient Global Impression of Change scale, at 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.
Measured: 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
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.
Measured: Baseline and 3 months post-intervention
Change from baseline in pain catastrophizing, as measured by the Pain Catastrophizing Scale, at 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).
Measured: Baseline and 3 months post-intervention
Change from baseline in mindfulness, as measured by the Five Facet Mindfulness Questionnaire, at 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.
Measured: 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.
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.
Measured: Baseline and 3 months post-intervention
Change from baseline in fatigue, as measured by the Brief Fatigue Inventory, at 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).
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Responsible party
- Sponsor
- Investigators
- Patricia Poulin, Ph.D, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758197
- Sponsor's protocol ID
- 20160164-01H
- Acronym
- COMPASSION
- Status last verified
- Nov 2020
- First submitted
- 28 Apr 2016
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02758197
- Acronym / sponsor ID
- COMPASSION / 20160164-01H
- Conditions
- Cancer, Painful Neuropathy, Chronic Pain, Worries; Pain or Disability
- Keywords
- Mindfulness, Chronic Pain, Quality of Life, Immune Function, Cancer survivors, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Cancer Society (CCS)
- Study start
- Jul 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary program including MBSR | Experimental | Behavioral: Mindfulness-Based Stress Reduction (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. |
| Wait-listed Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress Reduction (MBSR)Also: MBSRParticipants 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. | Behavioural | Interdisciplinary program including MBSR |
Primary outcome
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.
10 secondary outcomes
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Poulin, Ph.D principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Cancer and Painful Neuropathy, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.