Effects of Mindfulness Meditation and Stress Management After Breast Cancer

NCT02119481 | Completed

• 1 other identifier: KI-MBSR-Main-BC
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Mindfulness stress reduction training; Expressive writing condition; Waiting list control condition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Perceived stress

  Change from baseline to 12 months follow-up

• Change in Psychological well-being

  Change from baseline to 12-month follow-up

• Change in Sleep quality

  Change from baseline to 12-month follow-up

Other Outcomes (3)

• Sickness-absence for work

  At 24 months follow-up

• All cause morbidity

  At 24 months follow-up

• All cause mortality

  At 24 months follow-up

Study Arms (3)

Mindfulness-based stress reduction

EXPERIMENTAL

Mindfulness-based stress reduction training

Behavioral: Mindfulness-based stress reduction

Expressive writing condition

ACTIVE COMPARATOR

Expressive writing

Behavioral: Expressive writing condition

Waiting-list control condition

NO INTERVENTION

Waiting list

Interventions

Mindfulness-based stress reduction BEHAVIORAL

Also known as: MBSR, MBCT, Mindfulness based cognitive behavioral therapy

Mindfulness-based stress reduction

Expressive writing condition BEHAVIORAL

Also known as: Expressive writing

Expressive writing condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
• Access and regular use of the internet

You may not qualify if:

• Non Swedish speaking
• Previous sever psychiatric illness

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Department of clinical neuroscience

Stockholm, 171 77, Sweden

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: May 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: September 1, 2020

Record last verified: 2020-08

Locations

SE (1)