Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments mindfulness-based stress reduction, expressive writing condition
Sponsor Karolinska Institutet
Start date May 2014
End date June 2017
Trial size 142 participants
Trial identifier NCT02119481, KI-MBSR-Main-BC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Mindfulness-based stress reduction training
mindfulness-based stress reduction MBSR
(Active Comparator)
Expressive writing
expressive writing condition Expressive writing
(No Intervention)
Waiting list

Primary Outcomes

Measure
Change in Perceived Stress
time frame: Baseline to 8 week follow-up change
Change in Psychological Well-Being
time frame: Baseline to 8 week follow-up change
Change in Sleep quality
time frame: Baseline to 8 week follow-up change

Secondary Outcomes

Measure
Change in Perceived stress
time frame: Change from baseline to 12 months follow-up
Change in Psychological well-being
time frame: Change from baseline to 12-month follow-up
Change in Sleep quality
time frame: Change from baseline to 12-month follow-up

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Karolinska Institutet.