Effects of Mindfulness Meditation and Stress Management Training on Perceived Stress, Psychological Well-being, and Sleep Quality Among Patients Diagnosed With Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Richard Branstrom, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT02119481
First received: April 16, 2014
Last updated: April 18, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Karolinska Institutet:

Primary Outcome Measures:
  • Change in Perceived Stress [ Time Frame: Baseline to 8 week follow-up change ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Gorup differences in sickness-absence from work as measured in national population registries

  • All cause morbidity [ Time Frame: At 24 months follow-up ] [ Designated as safety issue: No ]
    Group differences in all cause morbidity as measured in national registries

  • All cause mortality [ Time Frame: At 24 months follow-up ] [ Designated as safety issue: No ]
    Group differences in all cause mortality as measured in national registries.


Estimated Enrollment: 210
Study Start Date: May 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: May 2016 (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

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT02119481

Locations
Sweden
Karolinska Institutet, Department of clinical neuroscience Not yet recruiting
Stockholm, Sweden, 171 77
Contact: Richard Branstrom, PhD    +46768111721    richard.branstrom@ki.se   
Contact: Pia Kvillemo, MSc    +706734864    pia.kvillemo@ki.se   
Principal Investigator: Richard Branstrom, PhD         
Sub-Investigator: Pia Kvillemo, MSc         
Sponsors and Collaborators
Karolinska Institutet
  More Information

No publications provided

Responsible Party: Richard Branstrom, Associate Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02119481     History of Changes
Other Study ID Numbers: KI-MBSR-Main-BC
Study First Received: April 16, 2014
Last Updated: April 18, 2014
Health Authority: Sweden: The National Board of Health and Welfare

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

Additional relevant MeSH terms:
Breast Neoplasms
Stress, Psychological
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014