Effects of Mindfulness Meditation and Stress Management After Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119481
• Other study ID #: KI-MBSR-Main-BC
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: June 2018

Study information

• Verified date: August 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Mindfulness-based stress reduction

• Expressive writing condition

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Department of clinical neuroscience	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sickness-absence for work	Gorup differences in sickness-absence from work as measured in national population registries	At 24 months follow-up
Other	All cause morbidity	Group differences in all cause morbidity as measured in national registries	At 24 months follow-up
Other	All cause mortality	Group differences in all cause mortality as measured in national registries.	At 24 months follow-up
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Change in Sleep quality	Change in sleep quality as measured with the Karolinska sleep questionnaire.	Change from baseline to 12-month follow-up