Effects of Mindfulness Meditation and Stress Management After Breast Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mindfulness-based stress reduction; Behavioral: Expressive writing condition

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 171 77
    • Karolinska Institutet, department of clinical neuroscience

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-based stress reduction; Mindfulness-based stress reduction training	Behavioral: Mindfulness-based stress reduction; Other Names: MBSR; MBCT; Mindfulness based cognitive behavioral therapy
Active Comparator: Expressive writing condition; Expressive writing	Behavioral: Expressive writing condition; Other Names: Expressive writing
No Intervention: Waiting-list control condition; Waiting list

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sickness-absence for work	Gorup differences in sickness-absence from work as measured in national population registries	At 24 months follow-up
All cause morbidity	Group differences in all cause morbidity as measured in national registries	At 24 months follow-up
All cause mortality	Group differences in all cause mortality as measured in national registries.	At 24 months follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: April 16, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (Estimate): April 21, 2014

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Mindfulness stress reduction training; Expressive writing condition; Waiting list control condition
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: KI-MBSR-Main-BC