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

This study has been completed.
Sponsor:
Collaborators:
University of Copenhagen
Herlev Hospital
Information provided by (Responsible Party):
Hanne Würtzen, Danish Cancer Society
ClinicalTrials.gov Identifier:
NCT00990977
First received: October 2, 2009
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Behavioral: mindfulness based stress reduction (MBSR)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Danish Cancer Society:

Primary Outcome Measures:
  • SCL-90r Depression and anxiety subscales [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical databases, containing information on BC (stage, treatment protocol) and comorbidity (other acute or chronic physical or psychiatric diseases) [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
  • standardized validated psychometric scales [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
    SCL-90r, NEO-PIR, FACIT-Sp, CES-D,MDI, WHO5, Inter99, IPAQ, FFMQ, BCPT-BEES,


Enrollment: 336
Study Start Date: March 2008
Study Completion Date: November 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: controls
assessment only
Experimental: cases
MBSR including brief information session and assessments
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Months to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women 18-75 years
  • operated for breast cancer stage I-III at either Herlev hospital (F-118) or Ringsted sygehus (Mammakirurgisk Klinik) after september 2006
  • speak and read danish

Exclusion Criteria:

  • other cancers
  • diseases or disabilities hindering MBSR-participation
  • active treatment for psychiatric disease including alcohol abuse
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00990977

Locations
Denmark
Danish Cancer Sociaty Research Center, Suvivorship
Copenhagen, Ø, Denmark, DK-2100
Sponsors and Collaborators
Danish Cancer Society
University of Copenhagen
Herlev Hospital
Investigators
Study Chair: Christoffer Johansen, M.D., Ph.D. Head Survivorship, Danish Cancer Society Research Center
  More Information

Additional Information:
No publications provided by Danish Cancer Society

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hanne Würtzen, Ph.d-fellow, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT00990977     History of Changes
Other Study ID Numbers: DanishCS, 2007-41-1654
Study First Received: October 2, 2009
Last Updated: January 19, 2012
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by Danish Cancer Society:
breast cancer
supportive care
post-treatment
intervention
MBSR
mindfulness
anxiety
depression
lifestyle
diet
alcohol consumption
smoking
exercise
spirituality
existential well-being
physical symptoms
women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014