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Effects of Mindfulness Meditation and Stress Management After Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Mindfulness-based stress reduction
Expressive writing condition
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet, Department of clinical neuroscience

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness-based stress reduction

Expressive writing condition

Waiting-list control condition

Arm Description

Mindfulness-based stress reduction training

Expressive writing

Waiting list

Outcomes

Primary Outcome Measures

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
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.
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.

Secondary Outcome Measures

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 in Psychological well-being
Change in psychological well-being as measured with the Psychological well-being scale.
Change in Sleep quality
Change in sleep quality as measured with the Karolinska sleep questionnaire.

Full Information

First Posted
April 16, 2014
Last Updated
August 31, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02119481
Brief Title
Effects of Mindfulness Meditation and Stress Management After Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based stress reduction
Arm Type
Experimental
Arm Description
Mindfulness-based stress reduction training
Arm Title
Expressive writing condition
Arm Type
Active Comparator
Arm Description
Expressive writing
Arm Title
Waiting-list control condition
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction
Other Intervention Name(s)
MBSR, MBCT, Mindfulness based cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing condition
Other Intervention Name(s)
Expressive writing
Primary Outcome Measure Information:
Title
Change in Perceived Stress
Description
Perceived stress as measured with the Perceived stress scale (PSS) and the Intrusion of event scale revised (IES-R) before and after intervention
Time Frame
Baseline to 8 week follow-up change
Title
Change in Psychological Well-Being
Description
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.
Time Frame
Baseline to 8 week follow-up change
Title
Change in Sleep quality
Description
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.
Time Frame
Baseline to 8 week follow-up change
Secondary Outcome Measure Information:
Title
Change in Perceived stress
Description
Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R)
Time Frame
Change from baseline to 12 months follow-up
Title
Change in Psychological well-being
Description
Change in psychological well-being as measured with the Psychological well-being scale.
Time Frame
Change from baseline to 12-month follow-up
Title
Change in Sleep quality
Description
Change in sleep quality as measured with the Karolinska sleep questionnaire.
Time Frame
Change from baseline to 12-month follow-up
Other Pre-specified Outcome Measures:
Title
Sickness-absence for work
Description
Gorup differences in sickness-absence from work as measured in national population registries
Time Frame
At 24 months follow-up
Title
All cause morbidity
Description
Group differences in all cause morbidity as measured in national registries
Time Frame
At 24 months follow-up
Title
All cause mortality
Description
Group differences in all cause mortality as measured in national registries.
Time Frame
At 24 months follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Karolinska Institutet, Department of clinical neuroscience
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden

12. IPD Sharing Statement

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Effects of Mindfulness Meditation and Stress Management After Breast Cancer

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