Pain ManagementNCT03591237
MBCT for Cancer Patients in Follow-Up
A study testing Mindfulness-Based Cognitive Therapy in people with Pain Management, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The objectives of the present study are: 1) to executing the practical implementation in an oncology department of MBCT for patients who have completed their primary treatment and experience significant cancer- and cancer-treatment-related pain, 2) to evaluate effects on pain and well-being, 3) to explore patient… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain Management
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Mar 2018to 1 Mar 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 yrs. of age
- completed primary cancer treatment
- experiencing moderate to severe pain >4 (11-point NRS)
Who cannot join
- incomplete chemotherapy or radiation therapy
- serious psychiatric diagnoses eg. psychosis
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites, 1 recruiting
- Active, not recruiting
Aarhus University
Aarhus, Jylland, 8000
- Recruiting
Dept of Oncology, Aarhus University Hospital
Aarhus, Jylland, 8000
Ingeborg Farver-Vestergaard, PhD-fellow, +4587166154, ifarver@psy.au.dk
Ingeborg Farver-Vestergaard, PhD
About this study
Official title: Mindfulness-based Cognitive Therapy for Pain in Cancer Patients After Primary Treatment: An Open Implementation Trial
The objectives of the present study are: 1) to executing the practical implementation in an oncology department of MBCT for patients who have completed their primary treatment and experience significant cancer- and cancer-treatment-related pain, 2) to evaluate effects on pain and well-being, 3) to explore patient satisfaction with the intervention offered, and 4) to explore possible organizational and individual physical, mental and socio-economic barriers for implementation in relation to drop-outs.
Read the detailed description
International research shows that untreated or under treated pain among cancer patients after completion of therapy is a common problem with substantial negative impact on the patients' quality of life and mental and physical function.These challenges have increased interest in psychological pain therapy and among the available methods of psychological intervention, mindfulness-based interventions (MBI) are of particular interest. MBI appears to be particularly relevant for pain, as mindfulness focuses, through different meditation exercises, on concentrating attention on here-and-now experiences and supporting new ways of addressing physical sensations and emotional discomfort, characterized by greater acceptance and openness. MBI has been shown effective in treatment of nonmalignant chronic pain. . Patients seen by all four diagnosis teams at the Oncology Department at AUH are screened for pain (0-10 NRS) in connection with their final consultation with the oncologist. Patients with a pain score of ≥ 4 on one or more of the four pain dimensions questions receive a folder describing MBCT and the treatment plan and are encouraged to contact the MBCT team for more information and scheduling of an interview. If the patient, after initial information either by phone or after the first interview decline the offer to participate, but are willing to be contacted for the purpose of gathering more information about their reasons for not participating, we will send them a brief questionnaire concerning their pain and their reasons for choosing to decline the offer, to complete online. They are also asked to give their permission to collect the same information after three months. All data are collected and registered with REDCap, a high data security project administration system administered by Aarhus University's Clinical Trial Unit. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. The program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including somewhat shorter sessions, shorter yoga exercises, and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain. The aim of the present project is to evaluate the practical implementation of MBCT, with focus on: 1) the observed effects on pain (primary outcome parameter), 2) effects on quality-of-life (QoL) and on other cancer and cancer-treatment-related late effects associated with pain (secondary outcome parameter), 3) possible barriers for continued participation in the program (drop-out), 4) patient experience and satisfaction with the intervention and its organizational/practical implementation, 5) staff's experience of screening procedure and implementation, and 6) collection of data for use in the evaluation of effects, costs, and savings. For use in the evaluation, the patients complete questionnaires prior to the first session (T1), immediately after the last session (T2), and at a six-month follow-up (T3).
- Conditions
- Pain Management
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- cancer, late effects, pain
- Medical subject headings
- Agnosia, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
The patients participate in eight weekly group sessions of two hours each and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. Generally, the program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including shorter sessions, shorter yoga exercises and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain.
| Study group | Role | What they receive |
|---|---|---|
| MBCT | Experimental | As patients with significant pain are identified and accept the offer of receiving 'Mindfulness-Based Cognitive Therapy' (MBCT) for pain, they will be consecutively included in groups of 12-20 participants. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home. Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by NRS
Pain intensity during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no pain, 10= worst pain ever).
Measured: Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain interference assessed by NRS
Pain interference with daily activities during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no interference, 10=maximal interference).
Measured: Change in pain interference from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Secondary outcomes (8)
Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)
Pain quality is assessed by the McGill Pain Questionnaire, which consists of 22 items representing different descriptors of pain. Each item is rated based on a 0-10 scale (0=no pain, 10=worst pain ever) during the last week. The questionnaire comprises of four parts, including continuous, intermittent, neuropathic and affective pain.
Measured: Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain burden assessed by NRS
Pain burden is assessed by a 11-point numeric rating scale (NRS), range 0-10 "How burdensome have your pain been during the last week" (0=not burdensome, 10=very burdensome).
Measured: Change in pain burden from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Cancer-related quality of life assessed by EORTC-QLQ-C30
Cancer-related quality of life is assessed with the European Organisation for Research and Treatment of Cancer's quality of life questionnaire (EORTC-QLQ-C30), which consists of 30 items.
Measured: Change in cancer-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Health-related quality of life assessed by the EQ-5D-3L
Health-realted quality of life is assessed by the EQ-5D, which consists of 5 items, measuring five dimensions of health status: mobility, self-case, usual activities, apin/discomfort, anxiety/depression. Each item is rated by marking a statement representing values at three levels 1-3. Higher scores indicate lower levels of quality of life.
Measured: Change in health-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Well-being assessed by the WHO-5
Well-being is assessed by the World Health Organization Well-Being Index (WHO-5), which consists of 5 items. Each item is rated on a 6-point Likert scale, ranging from 0-5. Higher scores indicate higher levels of well-being.
Measured: Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Fear of cancer recurrence assessed by the FCRI-SF
Fear of cancer recurrence is assessed with the Fear of Cancer Recurrence Inventory - Short Form (FCRI-SF), which consists of 9 items. Each item is rated on a 5-point Likert scale, ranging from 0-4. Higher scores indicate higher levels of fear of cancer recurrence.
Measured: Change in fear of cancer recurrence from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Symptoms of depression assessed by the BDI
Depressive symptoms are assessed by the Beck Depression Index (BDI), which consists of 21 items. Each item is rated by marking a statement representing values from 0-3. Higher scores indicate higher levels of depression symptoms.
Measured: Change in depression symptoms from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Sleep quality assessed by the ISI
Sleep difficulties are assessed by the Insomnia Severity Index (ISI), which consists of 7 items. Each item is rated on a 5-point Likert scale, ranging from 0-4. Higher scores indicate higher severity of insomnia.
Measured: Change in sleep quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Mar 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Zachariae, DMSCi, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591237
- Sponsor's protocol ID
- MBCT-late effects 2018
- Status last verified
- May 2019
- First submitted
- 26 Mar 2018
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Cognitive Therapy for Pain in Cancer Patients After Primary Treatment: An Open Implementation Trial
- ClinicalTrials.gov ID
- NCT03591237
- Acronym / sponsor ID
- MBCT-late effects 2018
- Conditions
- Pain Management
- Keywords
- cancer, late effects, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 19 Jul 2018 (actual)
- 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.
The objectives of the present study are: 1) to executing the practical implementation in an oncology department of MBCT for patients who have completed their primary treatment and experience significant cancer- and cancer-treatment-related pain, 2) to evaluate effects on pain and well-being, 3) to explore patient satisfaction with the intervention offered, and 4) to explore possible organizational and individual physical, mental and socio-economic barriers for implementation in relation to drop-outs.
Detailed description
International research shows that untreated or under treated pain among cancer patients after completion of therapy is a common problem with substantial negative impact on the patients' quality of life and mental and physical function.These challenges have increased interest in psychological pain therapy and among the available methods of psychological intervention, mindfulness-based interventions (MBI) are of particular interest. MBI appears to be particularly relevant for pain, as mindfulness focuses, through different meditation exercises, on concentrating attention on here-and-now experiences and supporting new ways of addressing physical sensations and emotional discomfort, characterized by greater acceptance and openness. MBI has been shown effective in treatment of nonmalignant chronic pain. . Patients seen by all four diagnosis teams at the Oncology Department at AUH are screened for pain (0-10 NRS) in connection with their final consultation with the oncologist. Patients with a pain score of ≥ 4 on one or more of the four pain dimensions questions receive a folder describing MBCT and the treatment plan and are encouraged to contact the MBCT team for more information and scheduling of an interview. If the patient, after initial information either by phone or after the first interview decline the offer to participate, but are willing to be contacted for the purpose of gathering more information about their reasons for not participating, we will send them a brief questionnaire concerning their pain and their reasons for choosing to decline the offer, to complete online. They are also asked to give their permission to collect the same information after three months. All data are collected and registered with REDCap, a high data security project administration system administered by Aarhus University's Clinical Trial Unit. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. The program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including somewhat shorter sessions, shorter yoga exercises, and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain. The aim of the present project is to evaluate the practical implementation of MBCT, with focus on: 1) the observed effects on pain (primary outcome parameter), 2) effects on quality-of-life (QoL) and on other cancer and cancer-treatment-related late effects associated with pain (secondary outcome parameter), 3) possible barriers for continued participation in the program (drop-out), 4) patient experience and satisfaction with the intervention and its organizational/practical implementation, 5) staff's experience of screening procedure and implementation, and 6) collection of data for use in the evaluation of effects, costs, and savings. For use in the evaluation, the patients complete questionnaires prior to the first session (T1), immediately after the last session (T2), and at a six-month follow-up (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBCT | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyAs patients with significant pain are identified and accept the offer of receiving 'Mindfulness-Based Cognitive Therapy' (MBCT) for pain, they will be consecutively included in groups of 12-20 participants. The patients will participate in eight weekly two hour group sessions and will be asked to do an additional 45 minutes of daily training at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 yrs. of age
- completed primary cancer treatment
- experiencing moderate to severe pain >4 (11-point NRS)
Key exclusion criteria (2 listed)
- incomplete chemotherapy or radiation therapy
- serious psychiatric diagnoses eg. psychosis
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 Cognitive TherapyThe patients participate in eight weekly group sessions of two hours each and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. Generally, the program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including shorter sessions, shorter yoga exercises and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain. | Behavioural | MBCT |
Primary outcome
Pain intensity assessed by NRS
Time frame: Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain intensity during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no pain, 10= worst pain ever).
Pain interference assessed by NRS
Time frame: Change in pain interference from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain interference with daily activities during the last week is assessed by a 11-point numeric rating scale (NRS), range 0-10. (0=no interference, 10=maximal interference).
8 secondary outcomes
Pain quality assessed by the McGill Pain Questionnaire (SF-MPQ-2)
Time frame: Change in pain quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Pain burden assessed by NRS
Time frame: Change in pain burden from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Cancer-related quality of life assessed by EORTC-QLQ-C30
Time frame: Change in cancer-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Health-related quality of life assessed by the EQ-5D-3L
Time frame: Change in health-related quality of life from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Well-being assessed by the WHO-5
Time frame: Change in well-being from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Fear of cancer recurrence assessed by the FCRI-SF
Time frame: Change in fear of cancer recurrence from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Symptoms of depression assessed by the BDI
Time frame: Change in depression symptoms from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Sleep quality assessed by the ISI
Time frame: Change in sleep quality from baseline (day 0) to post-intervention (up to 30 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- 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.
Robert Zachariae, DMSCi principal investigator
University of Aarhus
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Pain Management, run by University of Aarhus at 2 sites in Denmark.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ingeborg Farver-Vestergaard, Ph.D. (+4587166154, ifarver@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity assessed by NRS (time frame: Change in pain intensity from baseline (day 0) to post-intervention (up to 30 weeks after baseline)). The study lists 2 primary outcomes in all. 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 28 May 2019.