Effects of Mindfulness Meditation and Stress Management After Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Mindfulness-based stress reduction; Behavioral: Expressive writing condition

• Registration Number: NCT02119481
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Study Start: 2014-05
• Primary Completion: 2017-06
• Study Completion: 2018-06
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

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

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Exclusion Criteria

• Non Swedish speaking
• Previous sever psychiatric illness

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based stress reduction	Mindfulness-based stress reduction	Mindfulness-based stress reduction training
Expressive writing condition	Expressive writing condition	Expressive writing

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress	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 Sleep quality	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	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.

Secondary Outcome Measures

Name	Time	Method
Change in Perceived stress	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	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	Change from baseline to 12-month follow-up	Change in sleep quality as measured with the Karolinska sleep questionnaire.

Trial Locations

Locations (1)

Karolinska Institutet, Department of clinical neuroscience; 🇸🇪 Stockholm, Sweden