Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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:

        -  report of anxiety and depression will decrease among cases

        -  better compliance will lead to more decrease in levels of anxiety and depression

        -  cases will make lifestyle changes suitable with recommendations for BC patients in
           post-treatment phase of the illness

        -  decreased level of anxiety and depression will reflect improved spiritual well-being

        -  improved spiritual wellbeing will lead to decreased report of physical symptoms

      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.
    

Detailed description: 
      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.

      Research questions

        -  We do not know whether all types of cancer patients will benefit from MBSR. Especially
           patients compliance must be empirically documented

        -  Cancer accentuates an array of existential concerns and the effect of MBSR on these
           subjective concerns must be examined

      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.

        -  Questionnaire Prior to randomization and as follow-up after 6 and 12 months both study
           groups will be mailed questionnaires containing validated psychometric

        -  Hospital charts Descriptions of breast cancer operation, pathology of tumor as well as
           day to day entries will be collected.

        -  Administrative registries Data regarding comorbidity of all eligible patients will be
           collected in National Patient Registry and Central Psychiatric Registry upon
           finalization of the project.

        -  Qualitative outcomes Data collected by standardized self-report instruments will be
           supplemented by qualitative interviews inviting the intervention group participants to
           present themselves by giving an account of the treatment and a personal evaluation of
           the potential benefit.

      Analysis

        -  Quantitative data Data will be stores in a database at the institute. Logistic
           regression analysis will be applied to evaluate which background variables effects
           participation. Analysis of outcomes will be conducted by applying multiple regressions
           at each time point. For simultaneous analysis of all follow-up times a linear mixed
           model with random effects of persons will be fitted. Outcomes as relapse and death among
           intervention group in comparison to both control group and non-participants will be
           analyzed by use of Cox regression model, controlling for the effect of biological and
           demographic variables. Analysis will be conducted under supervision of a senior
           statistician at the Department of Statistics and Epidemiology at the Institute.

        -  Qualitative data Based on the qualitative interviews a set of data-driven categories
           will be developed. These categories will be quantitatively evaluated. The transcript of
           the patient's self-presentation (approximately 2 pages) will be analyzed by use of
           qualitative methods, allowing for grouping of content categories as expressed by the
           patients. Statistical analysis will be applied to evaluate these categories.

      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.

      Reference List

        1. Ross L, Boesen E, Dalton S, Johansen C. Mind and cancer: does psychological intervention
           improve suvival and psychological well-being? European Journal of Cancer 2001.

        2. Ott MJ, Norris RL, Bauer-Wu SM. Mindfulness meditation for oncology patients: a
           discussion and critical review. Integr Cancer Ther 2006; 5(2):98-108.

        3. Bower JE, Ganz PA, Desmond KA, Rowland JH, Meyerowitz BE, Belin TR. Fatigue in Breast
           Cancer Survivors: Occurrence, Correlates, and Impact on Quality of Life. J Clin Oncol
           2000; 18(4):743.

        4. Bower JE, Ganz PA, Desmond KA et al. Fatigue in long-term breast carcinoma survivors: a
           longitudinal investigation. Cancer 2006; 106(4):751-758.
    

Intervention name(s): mindfulness based stress reduction (MBSR)
Intervention type(s): Behavioral
Intervention description(s): 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 intervention name(s): MBSR (Kabat-Zinn)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breast cancer; supportive care; post-treatment; intervention; MBSR; mindfulness; anxiety; depression; lifestyle; diet; alcohol consumption; smoking; exercise; spirituality; existential well-being; physical symptoms; women