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Completed

NCT Number: NCT02119481

Effects of Mindfulness Meditation and Stress Management After 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet, Department of clinical neuroscience

Stockholm, 171 77, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-Based Stress Reduction

Behavioral

Other names: MBSR, MBCT, Mindfulness based cognitive behavioral therapy

Expressive writing condition

Behavioral

Other names: Expressive writing

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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)

  2. 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.

  3. 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.

Other outcomes

  1. Sickness-absence for work

    Time frame: At 24 months follow-up

    Gorup differences in sickness-absence from work as measured in national population registries

  2. All cause morbidity

    Time frame: At 24 months follow-up

    Group differences in all cause morbidity as measured in national registries

  3. All cause mortality

    Time frame: At 24 months follow-up

    Group differences in all cause mortality as measured in national registries.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Apr 21, 2014
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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