Breast CancerNCT01674881
The Effectiveness of Mindfulness on Chronic Pain in Breast Cancer Survivors
A study testing Mindfulness-Based Cognitive Therapy and Waitlist in people with Breast Cancer and Chronic Pain, run by University of Aarhus at 1 site in Denmark.
Trial summary
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Chronic Pain
- What is being tested?
- Mindfulness-Based Cognitive Therapy and Waitlist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2012to Jan 2015
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A timeframe of >3 months from surgery, radiation- and chemotherapy and a minimum score of >3 on a pain scale from 0-10 corresponding to moderate pain
Who cannot join
- Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand Danish, and chronic pain otherwise associated with the musculoskeletal system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.
Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.
Read more
The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.
The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.
- Conditions
- Breast Cancer, Chronic Pain
- Being tested
- Mindfulness-Based Cognitive Therapy, Waitlist
- Keywords
- Mindfulness, breast cancer, chronic pain, mediators, distress, Breast cancer survivors, Effectiveness of MBCT on chronic pain, Potential mediators and moderators, Effectiveness of MBCT on psychological symptoms
- Medical subject headings
- Breast Neoplasms, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyOther
MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).
Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD.
WaitlistOther
Waitlist: participants are offered the intervention (MBCT) after the completion of the main study
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | This group will receive MBCT for 8 consecutive weeks. Receives: Other: Mindfulness-Based Cognitive Therapy |
| Waitlist control group | Other | This group is a waitlist control group. Receives: Other: Waitlist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Revised McGill Pain Questionnaire Short Form
VAS: pain interference
Additional items: Pain descriptors
Measured: From baseline until 6 months
Secondary outcomes (5)
Mindfulness
The Five Facet Mindfulness Questionnaire
Measured: From baseline until 6 months
Self compassion
the Self Compassion Scale Short Form
Measured: From baseline until 6 months
Pain Catastrophizing
the Pain Catastrophizing Scale
Measured: From baseline until 6 months
Depression and anxiety
the Hospital Anxiety and Depression Scale
Measured: From baseline until 6 months
Well-being
the WHO-5
Measured: From baseline until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maja Johannsen, PhD-fellow, MSc psychology, Principal investigator, Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University HospitalRobert Zachariae, Professor, MDSci., MSc, Principal investigator, Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674881
- Sponsor's protocol ID
- EPoS-1
- Status last verified
- Aug 2013
- First submitted
- 24 Aug 2012
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Johannsen M, O'Connor M, O'Toole MS, Jensen AB, Hojris I, Zachariae R. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Oct 1;34(28):3390-9. doi: 10.1200/JCO.2015.65.0770. Epub 2016 Jun 20.
PubMed 27325850
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) on Chronic Pain in Women Treated for Breast Cancer
- ClinicalTrials.gov ID
- NCT01674881
- Acronym / sponsor ID
- EPoS-1
- Conditions
- Breast Cancer, Chronic Pain
- Keywords
- Mindfulness, breast cancer, chronic pain, mediators, distress, Breast cancer survivors, Effectiveness of MBCT on chronic pain, Potential mediators and moderators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Aug 2012 (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.
A recent epidemiologic survey has indicated that approx. 42% of Danish women treated for breast cancer experience negative sequelae in the form of pain following treatment. Chronic pain is known to be associated with impaired social and emotional functioning, and thus presents a particular concern.
Mindfulness-based intervention is among the complementary, psychological treatments, which cancer patients commonly seek out in relation to the course of their illness. Despite the popularity of mindfulness-based intervention among cancer patients, no studies have so far investigated the effect of mindfulness-based intervention on chronic pain in breast cancer patients. While no studies so far have focused on pain, there is evidence to suggest that mindfulness-based intervention is associated with improved psychosocial adaption to cancer. Furthermore, non-cancer research suggests that mindfulness-based intervention is associated with reduced pain experiences.
The aim of this project is to investigate the effect of Mindfulness-Based Cognitive Therapy (MBCT) on chronic pain in breast cancer patients. Women who have completed their treatment for breast cancer and who experience chronic pain, will be randomized to an intervention group (MBCT) or a treatment-as-usual control group. All participants will be assessed at the same time points, i.e. before the intervention (baseline), and three times after the intervention/control condition, with the last follow-up 6 months after the intervention. In addition, a number of potential moderators and mediators of the outcome will be explored. For example, recent studies indicate that adult attachment style may constitute an important moderator and/or mediator in the development of pain, and preliminary research has suggested that attachment style may moderate the effect of mindfulness-based intervention.
The results will provide valuable new knowledge about the potential of MBCT as a treatment strategy for chronic pain in breast cancer patients, will contribute to the clarification of underlying mechanisms in the experience of and coping with pain, which could help the development of more effective, individualized interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy (MBCT) | Experimental | Other: Mindfulness-Based Cognitive TherapyThis group will receive MBCT for 8 consecutive weeks. |
| Waitlist control group | Other | Other: WaitlistThis group is a waitlist control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A timeframe of >3 months from surgery, radiation- and chemotherapy and a minimum score of >3 on a pain scale from 0-10 corresponding to moderate pain
Key exclusion criteria (1 listed)
- Breast cancer recurrence, bilateral breast cancer, other cancer, psychiatric illnesses, insufficient ability to speak and understand Danish, and chronic pain otherwise associated with the musculoskeletal system
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 TherapyMBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min). Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD. | Other | Mindfulness-Based Cognitive Therapy (MBCT) |
| WaitlistWaitlist: participants are offered the intervention (MBCT) after the completion of the main study | Other | Waitlist control group |
Primary outcome
Pain
Time frame: From baseline until 6 months
Revised McGill Pain Questionnaire Short Form VAS: pain interference Additional items: Pain descriptors
5 secondary outcomes
Mindfulness
Time frame: From baseline until 6 months
Self compassion
Time frame: From baseline until 6 months
Pain Catastrophizing
Time frame: From baseline until 6 months
Depression and anxiety
Time frame: From baseline until 6 months
Well-being
Time frame: From baseline until 6 months
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 14 Apr 2015.
- Derived from this study: PubMed 27325850Johannsen M, O'Connor M, O'Toole MS, Jensen AB, Hojris I, Zachariae R. Efficacy of Mindfulness-Based Cognitive Therapy on Late Post-Treatment Pain in Women Treated for Primary Breast Cancer: A Randomized Controlled Trial. J Clin Oncol. 2016 Oct 1;34(28):3390-9. doi: 10.1200/JCO.2015.65.0770. Epub 2016 Jun 20.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Maja Johannsen, PhD-fellow, MSc psychology principal investigator
Unit for Psychooncology and Health Psychology, Aarhus University and Aarhus University Hospital
Robert Zachariae, Professor, MDSci., MSc principal investigator
Unit for Psychooncology and Health Psychology, Aarhus University Hospital and Aarhus University
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 Cognitive Therapy and Waitlist in people with Breast Cancer and Chronic Pain, run by University of Aarhus at 1 site 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 1 inclusion and 1 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 14 Apr 2015. 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 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?
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?
Pain (time frame: From baseline until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01674881, which also lists 1 linked publication.
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 14 Apr 2015.