Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer (MICA)
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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 |
- SCL-90r Depression and anxiety subscales [ Time Frame: baseline - 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Denmark | |
| Danish Cancer Sociaty Research Center, Suvivorship | |
| Copenhagen, Ø, Denmark, DK-2100 | |
| 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 May 16, 2013