Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer

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.

Conditions

• Breast Cancer

Interventions

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.

Sponsors & Collaborators

• University of Copenhagen

  collaborator OTHER

• Herlev Hospital

  collaborator OTHER

• Danish Cancer Society

  lead OTHER

Principal Investigators

• Christoffer Johansen, M.D., Ph.D. · Head Survivorship, Danish Cancer Society Research Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-03-31

Primary Completion

2010-12-31

Completion

2011-11-30

Countries

• Denmark

Study Locations