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

NCT00990977 | Completed Phase 2

• 2 other identifiers: DanishCS2007-41-1654
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief 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

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

Outcome Measures

Primary Outcomes (1)

• SCL-90r Depression and anxiety subscales

  baseline - 12 months

Secondary Outcomes (2)

• clinical databases, containing information on BC (stage, treatment protocol) and comorbidity (other acute or chronic physical or psychiatric diseases)

  baseline - 12 months

• standardized validated psychometric scales

  baseline - 12 months

Study Arms (2)

controls

NO INTERVENTION

assessment only

cases

EXPERIMENTAL

MBSR including brief information session and assessments

Behavioral: mindfulness based stress reduction (MBSR)

Interventions

mindfulness based stress reduction (MBSR) BEHAVIORAL

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.

Also known as: MBSR (Kabat-Zinn)

cases

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other cancers
• diseases or disabilities hindering MBSR-participation
• active treatment for psychiatric disease including alcohol abuse

Sponsors & Collaborators

• Danish Cancer Society: lead
• University of Copenhagen: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Danish Cancer Sociaty Research Center, Suvivorship

Copenhagen, Ø, DK-2100, Denmark

Location

Related Publications (5)

• Wurtzen H, Dalton SO, Christensen J, Andersen KK, Elsass P, Flyger HL, Pedersen AE, Sumbundu A, Steding-Jensen M, Johansen C. Effect of mindfulness-based stress reduction on somatic symptoms, distress, mindfulness and spiritual wellbeing in women with breast cancer: Results of a randomized controlled trial. Acta Oncol. 2015 May;54(5):712-9. doi: 10.3109/0284186X.2014.997371. Epub 2015 Mar 9.

  PMID: 25752972 DERIVED

• Jensen CG, Elsass P, Neustrup L, Bihal T, Flyger H, Kay SM, Khan S, Jensen SS, Pedersen A, Wurtzen H. What to listen for in the consultation. Breast cancer patients' own focus on talking about acceptance-based psychological coping predicts decreased psychological distress and depression. Patient Educ Couns. 2014 Nov;97(2):165-72. doi: 10.1016/j.pec.2014.07.020. Epub 2014 Jul 22.

  PMID: 25086446 DERIVED

• Andersen SR, Wurtzen H, Steding-Jessen M, Christensen J, Andersen KK, Flyger H, Mitchelmore C, Johansen C, Dalton SO. Effect of mindfulness-based stress reduction on sleep quality: results of a randomized trial among Danish breast cancer patients. Acta Oncol. 2013 Feb;52(2):336-44. doi: 10.3109/0284186X.2012.745948. Epub 2013 Jan 3.

  PMID: 23282113 DERIVED

• Wurtzen H, Dalton SO, Elsass P, Sumbundu AD, Steding-Jensen M, Karlsen RV, Andersen KK, Flyger HL, Pedersen AE, Johansen C. Mindfulness significantly reduces self-reported levels of anxiety and depression: results of a randomised controlled trial among 336 Danish women treated for stage I-III breast cancer. Eur J Cancer. 2013 Apr;49(6):1365-73. doi: 10.1016/j.ejca.2012.10.030. Epub 2012 Dec 19.

  PMID: 23265707 DERIVED

• Wurtzen H, Dalton SO, Andersen KK, Elsass P, Flyger HL, Sumbundu A, Johansen C. Who participates in a randomized trial of mindfulness-based stress reduction (MBSR) after breast cancer? A study of factors associated with enrollment among Danish breast cancer patients. Psychooncology. 2013 May;22(5):1180-5. doi: 10.1002/pon.3094. Epub 2012 May 16.

  PMID: 22592966 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders; Depression; Alcohol Drinking; Smoking; Motor Activity

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christoffer Johansen, M.D., Ph.D.

  Head Survivorship, Danish Cancer Society Research Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.d-fellow

Study Record Dates

• First Submitted: October 2, 2009
• First Posted: October 7, 2009
• Study Start: March 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: November 1, 2011
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

DK (1)