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Clinical Trials/NCT02119481
NCT02119481
Completed
Not Applicable

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

Karolinska Institutet1 site in 1 country142 target enrollmentMay 2014
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Karolinska Institutet
Enrollment
142
Locations
1
Primary Endpoint
Change in Sleep quality
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
June 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Richard Branstrom

Associate Professor

Karolinska Institutet

Eligibility 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

Outcomes

Primary Outcomes

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.

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 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

Secondary Outcomes

  • Change in Perceived stress(Change from baseline to 12 months follow-up)
  • Change in Psychological well-being(Change from baseline to 12-month follow-up)
  • Change in Sleep quality(Change from baseline to 12-month follow-up)

Study Sites (1)

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