Effects of Mindfulness Meditation and Stress Management After Breast Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Mindfulness-based stress reduction
* Behavioral: Expressive writing condition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based stress reduction<br>Mindfulness-based stress reduction training | Behavioral: Mindfulness-based stress reduction<br> <br> * Other names: Mindfulness based cognitive behavioral therapy;|
| Active Comparator: Expressive writing condition<br>Expressive writing | Behavioral: Expressive writing condition<br> <br> * Other names: Expressive writing;|
| No Intervention: Waiting-list control condition<br>Waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress | Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention | Baseline to 8 week follow-up change | 
| Change in Psychological Well-Being | 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. | Baseline to 8 week follow-up change | 
| Change in Sleep quality | 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. | Baseline to 8 week follow-up change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived stress | Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R) | Change from baseline to 12 months follow-up | 
| Change in Psychological well-being | Change in psychological well-being as measured with the Psychological well-being scale. | Change from baseline to 12-month follow-up | 
| Change in Sleep quality | Change in sleep quality as measured with the Karolinska sleep questionnaire. | Change from baseline to 12-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition