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Effects of Mindfulness Meditation and Stress Management After Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02119481
First Posted: April 21, 2014
Last Update Posted: August 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard Branstrom, Karolinska Institutet
  Purpose
The primary aim of this study is to examine the effects of a mindfulness-based stress reduction training program, delivered in individual web-based sessions, among breast cancer patients. The objectives are to study and answer questions regarding effects of the such training in a randomized controlled trial including the following outcome measures: physical and mental health status, perceived stress, post-traumatic stress symptoms, psychological well-being, and sleep quality. In addition to the primary aim, the investigators plan to explore potential mechanisms through which mindfulness training lead to improvement in perceived stress, well-being and sleep-quality. This will be studied by mediational analyses.

Condition Intervention
Breast Cancer Behavioral: Mindfulness-based stress reduction Behavioral: Expressive writing condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Mindfulness Meditation and Stress Management Training on Perceived Stress, Psychological Well-being, and Sleep Quality Among Patients Diagnosed With Breast Cancer

Resource links provided by NLM:


Further study details as provided by Richard Branstrom, Karolinska Institutet:

Primary Outcome Measures:
  • Change in Perceived Stress [ Time Frame: Baseline to 8 week follow-up change ]
    Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention

  • Change in Psychological Well-Being [ Time Frame: Baseline to 8 week follow-up change ]
    Psychological Well-Being as measured with the Psychological Well-Being (PWB) scale by C Ryff; a questionnaire measuring six dimensions of psychological well-being: environmental mastery; self-acceptance; positive relations with others; purpose in life; personal growth; and autonomy.

  • Change in Sleep quality [ Time Frame: Baseline to 8 week follow-up change ]
    Sleep quality as measured with the Karolinska Sleep Questionnaire (KSQ) a 13-item questionnaire assessing sleep-time and quality as well as perceived satisfaction with sleep, sleepiness and sleep disturbance.


Secondary Outcome Measures:
  • Change in Perceived stress [ Time Frame: Change from baseline to 12 months follow-up ]
    Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R)

  • Change in Psychological well-being [ Time Frame: Change from baseline to 12-month follow-up ]
    Change in psychological well-being as measured with the Psychological well-being scale.

  • Change in Sleep quality [ Time Frame: Change from baseline to 12-month follow-up ]
    Change in sleep quality as measured with the Karolinska sleep questionnaire.


Other Outcome Measures:
  • Sickness-absence for work [ Time Frame: At 24 months follow-up ]
    Gorup differences in sickness-absence from work as measured in national population registries

  • All cause morbidity [ Time Frame: At 24 months follow-up ]
    Group differences in all cause morbidity as measured in national registries

  • All cause mortality [ Time Frame: At 24 months follow-up ]
    Group differences in all cause mortality as measured in national registries.


Enrollment: 142
Study Start Date: May 2014
Estimated Study Completion Date: June 2018
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness-based stress reduction
Mindfulness-based stress reduction training
Behavioral: Mindfulness-based stress reduction
Other Names:
  • MBSR
  • MBCT
  • Mindfulness based cognitive behavioral therapy
Active Comparator: Expressive writing condition
Expressive writing
Behavioral: Expressive writing condition
Other Name: Expressive writing
No Intervention: Waiting-list control condition
Waiting list

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
  • Access and regular use of the internet

Exclusion Criteria:

  • Non Swedish speaking
  • Previous sever psychiatric illness
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119481


Locations
Sweden
Karolinska Institutet, Department of clinical neuroscience
Stockholm, Sweden, 171 77
Sponsors and Collaborators
Karolinska Institutet
  More Information

Responsible Party: Richard Branstrom, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02119481     History of Changes
Other Study ID Numbers: KI-MBSR-Main-BC
First Submitted: April 16, 2014
First Posted: April 21, 2014
Last Update Posted: August 21, 2017
Last Verified: August 2017

Keywords provided by Richard Branstrom, Karolinska Institutet:
Mindfulness stress reduction training
Expressive writing condition
Waiting list control condition

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