Clinical trial · Interventional
Mindfulness and Cancer Mamma - Clinical Trial MBSR Among Women Operated for Breast Cancer
A Prospective, Randomized Controlled Trial of Mindfulness-based Stress Reduction (MBSR) Among Women Operated for Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mindfulness based stress reduction (MBSR) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- controls
- description
- assessment only
- type
- EXPERIMENTAL
- label
- cases
- description
- MBSR including brief information session and assessments
- interventionNames
- Behavioral: mindfulness based stress reduction (MBSR)
Primary outcomes (1)
- measure
- SCL-90r Depression and anxiety subscales
- timeFrame
- baseline - 12 months
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (5)
- DERIVEDWurtzen 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
- DERIVEDJensen 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
- DERIVEDAndersen 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
- DERIVEDWurtzen 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
- DERIVEDWurtzen 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