Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer (MICA)
|ClinicalTrials.gov Identifier: NCT00990977|
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : June 30, 2015
|First Submitted Date ICMJE||October 2, 2009|
|First Posted Date ICMJE||October 7, 2009|
|Last Update Posted Date||June 30, 2015|
|Study Start Date ICMJE||March 2008|
|Actual Primary Completion Date||December 2010 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||SCL-90r Depression and anxiety subscales [ Time Frame: baseline - 12 months ]|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00990977 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer|
|Official Title ICMJE||A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer|
The number of Danish women treated for breast cancer rise every year, though survival rates have improved, women can still expect to experience the diverse late effects reported by this group of patients. Mindfulness labels the ability to be aware of the present moment - thereby avoiding speculations about both past and present. Mindfulness based stress-reduction (MBSR) is an 8-week program, covering 24 contact-hours and 45 minutes daily home practice. The program aims at developing participants' coping resources and developing participants' mindful awareness. Thus the program consists of guided meditations, guided body scan(a specific awareness exercise)and through meditation, yoga and psychoeducation concerning stress and stress-reactions, while meditation and bodyscan is practiced at home by the use of specific audio-CDs guiding the patient. The MBSR-program have shoved promising results among patients with anxiety-disorders, depression and chronic pain. Smaller studies have also found positive effects of the program among cancer patients. The investigators want to evaluate the effect of the MBSR program on levels of anxiety and depression as well as the possible influence of mindfulness training on health behaviors and existential concerns. The study are based on the following hypotheses:
All participants in this randomized controlled trial will fill out questionnaires at enrollment and as 1, 6 and 12 months follow-up. Based on results from this trial clinicians and patients will be able to make decisions regarding post-treatment psychosocial intervention and researchers will have initial evidence of the effect of the intervention and thus possible indications for research on mindfulness among patients diagnosed with cancer at other stages or sites.
Original Research Protocol, Copenhagen January 2007 Cancer and Mindfulness: A prospective, randomized trial of a psychosocial intervention among women operated for breast cancer
Background From the time of diagnosis cancer patients have a need for psychological support. Many patients handle the situation by the help of friends and family, while others need professional support to come to terms with different phases of life as a cancer patient. Only few randomized trials have been conducted in order to determine what kinds of professional support patients will benefit from. These studies conclude that the prevalence of anxiety and depression in reduced. This is of major importance as depending of cancer type, treatment modality, age and gender, a total of 10-50 % of Danish cancer patients reports such well-defined psychosocial symptoms following the diagnosis of cancer.
Mindfulness meditation aims to increase the experience of presence and an increased relation to several emotional and sensory experiences. Instead of being a technique aimed to control and change unwanted psychological states the method is rather a way to stay present in the here and now without judging and as such it has been developed into a stress reduction method: mindfulness based stress reduction (MBSR). The method is taught within a group setting by an instructor guiding the patients during a week long program. The method has been evaluated within a variety of settings and has been found to effectively reduce symptoms related to different stress and pain conditions i.e. psoriasis, chronic pain, HIV/AIDS, anxiety and depression.2 Based on these experiences several programs have been developed and the program developed by Williams and Kabatt-Zinn has gained status as the most commonly applied and best validated. Within recent years the program has been included into cognitive-behavioral therapy. But with potential effects not only as reduction of symptoms but further opens the opportunity for participants to approach spiritual and existential themes. The potential effect is therefore not limited to simple reduction of symptoms but includes increased meaningfulness, quality of life and sense of coherence.
Nine studies of the effect of MBSR haw been conducted, including 10- 157 adult cancer patients being taught MBSR in groups of mainly breast cancer patients, but only three of these trials have been conducted as randomized controlled trials. I these trials patients have self-referred (selection bias), analysis have not been adjusted for biological status of the cancer disease (confounding), samples have been small (n=10-157) (type 2 error) and patients have differed with regard to time since diagnosis (misclassification). Despite these methodological limitations a tendency of positive effects of MBSR participation on psychological and physiological outcomes has been observed.
Yet it is still not determined whether MBSR will provide cancer patients benefit improving their daily life with cancer. Some important aspects have not been addressed in previous studies: When MBSR is applied as an intervention dose-response relation has only been observed among patients with a moderate level of symptoms. Thus sensitivity of MBSR in relation to stages of cancer, levels of pain or negative effects of treatments. We still do not know whether all cancer patients will profit from this type of intervention. Further the influence of patient compliance and working alliance is still not explored.
The diagnosis of cancer accentuates existential dimensions as spirituality and quality of life. Yet we do not know how MBSR can support patients in dealing with such themes. Be review of literature regarding patients coping with cancer the patients demand for interventions supporting their need to deal with existential themes is striking.
Aim We will conduct a randomized controlled trial among women diagnosed with primary breast cancer in order to evaluate the effect of MBSR on depression, anxiety quality of life, health behavior and psychological well-being.
Inclusion All patient diagnosed with primary breast cancer in Department of Breast Surgery, Copenhagen Hospital Herlev, will be invited to participate in the study and in the randomization allocating patients to either MBSR intervention or treatment as usual control. Patients diagnosed and in active treatment for major psychiatric disease, patients with musculoskeletal disease and cardiovascular disease hindering MBSR participation, and patients previously diagnosed with other cancers than non-melanoma skin cancer will be excluded. A project nurse will contact eligible patients, deliver oral and written information and collect informed consent. If the patient consents baseline questionnaire will be administered.
Randomization will then take place. The project nurse will up-load patient data on secured project home-page. Computer generated sequence will automatically assign a unique study number to each patient indicating which study group she is allocated to. Result of the randomization will be delivered to the patient by the project nurse and potential disappointment will be handles at this point, and information regarding optional counseling provided by the Danish Cancer Society will also be given.
Intervention group MBSR will be delivered in groups of maximum 20 participants. The course will follow an 8 week schedule with 2-2½ hour sessions each week and instruction to practice 45 minutes daily at home. Upon conclusion of the course each group will participate in a full-day course (8 hours). The courses will be delivered by a manual (including audio CDs) developed by Antonia Sumbundu (see attached file). The group must meet in a quiet room large enough to room 20 persons lying down, as well as mats, carpets and chairs. The courses will be delivered in locations not affiliated with a hospital.
Control group The control group will receive treatment as usual and thus follow the standard control program applied by the surgical department.
Ethics Application of permission to conduct the study will be submitted to the The National Committee on Health Research Ethics and to the Danish Data Protection Agency. In information to patients regarding the study it will be stressed that participation is voluntary and that patients withdraw without any explanation at any time, and that withdrawal will have no influence on treatments delivered. Both written and oral consent must be given prior to participation. A short report will be mailed to all participants upon conclusion of the study. Vital status of participants will be checked in Central Persons Registry prior to any sending of study questionnaire. Data kept in the study database will be encrypted ensuring that only authorized scientific staff will be able to identify individuals. The encryption code will be kept by study manager. Results will be reported as tables and figures hindering identification of individuals. Also in the reporting of qualitative data will the quoted participants be kept anonymous.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Condition ICMJE||Breast Cancer|
|Intervention ICMJE||Behavioral: mindfulness based stress reduction (MBSR)
MBSR is an 8-week course covering a total of 24 contact hours where the group of patients meet with an clinical psychologist certified as mindfulness instructor. The group will train the ability of mindfulness by specific awareness improving practises (body-scan) guided meditations and soft yoga. Between group-sessions participants are recommended to practice 45 minutes daily and to go through instructions in MBSR hand-outs. Participants will be given audio-CDs containing instructions and guides to support home practice.
Other Name: MBSR (Kabat-Zinn)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Actual Enrollment ICMJE
|Actual Study Completion Date||November 2011|
|Actual Primary Completion Date||December 2010 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 75 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Denmark|
|Removed Location Countries|
|NCT Number ICMJE||NCT00990977|
|Other Study ID Numbers ICMJE||DanishCS
2007-41-1654 ( Registry Identifier: Danish Data Protection Agency )
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Trille Kjær, Danish Cancer Society|
|Study Sponsor ICMJE||Danish Cancer Society|
|PRS Account||Danish Cancer Society|
|Verification Date||June 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP