Effects of Mindfulness Meditation and Stress Management After Breast Cancer
|ClinicalTrials.gov Identifier: NCT02119481|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2014
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: Mindfulness-based stress reduction Behavioral: Expressive writing condition||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|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|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2018|
Experimental: Mindfulness-based stress reduction
Mindfulness-based stress reduction training
Behavioral: Mindfulness-based stress reduction
Active Comparator: Expressive writing condition
Behavioral: Expressive writing condition
Other Name: Expressive writing
No Intervention: Waiting-list control condition
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119481
|Karolinska Institutet, Department of clinical neuroscience|
|Stockholm, Sweden, 171 77|