Breast CancerNCT02119481
Effects of Mindfulness Meditation and Stress Management After Breast Cancer
A study testing Mindfulness-based stress reduction and Expressive writing condition in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mindfulness-based stress reduction and Expressive writing condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
- Access and regular use of the internet
Who cannot join
- Non Swedish speaking
- Previous sever psychiatric illness
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Department of clinical neuroscience
Stockholm, 171 77
About this study
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
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
- Being tested
- Mindfulness-based stress reduction, Expressive writing condition
- Keywords
- Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based stress reductionBehavioural
Also called MBSR, MBCT, Mindfulness based cognitive behavioral therapy
Expressive writing conditionBehavioural
Also called Expressive writing
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Mindfulness-based stress reduction training Receives: Behavioral: Mindfulness-based stress reduction |
| Expressive writing condition | Active comparator | Expressive writing Receives: Behavioral: Expressive writing condition |
| Waiting-list control condition | No intervention | Waiting list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Baseline to 8 week follow-up change
Secondary outcomes (3)
Change in Perceived stress
Change in Perceived stress as measured with the Perceived stress scale and the Intrusion of event scale revised (IES-R)
Measured: 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.
Measured: Change from baseline to 12-month follow-up
Change in Sleep quality
Change in sleep quality as measured with the Karolinska sleep questionnaire.
Measured: Change from baseline to 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Branstrom, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119481
- Sponsor's protocol ID
- KI-MBSR-Main-BC
- Status last verified
- Aug 2020
- First submitted
- 16 Apr 2014
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02119481
- Acronym / sponsor ID
- KI-MBSR-Main-BC
- Conditions
- Breast Cancer
- Keywords
- Mindfulness stress reduction training, Expressive writing condition, Waiting list control condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction | Experimental | Behavioral: Mindfulness-based stress reductionMindfulness-based stress reduction training |
| Expressive writing condition | Active comparator | Behavioral: Expressive writing conditionExpressive writing |
| Waiting-list control condition | No intervention | –Waiting list |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Breast cancer patient ≥ 18 years of age who has received the cancer diagnosis ≤ 2 years previously
- Access and regular use of the internet
Key exclusion criteria (2 listed)
- Non Swedish speaking
- Previous sever psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based stress reductionAlso: MBSR, MBCT, Mindfulness based cognitive behavioral therapy | Behavioural | Mindfulness-based stress reduction |
| Expressive writing conditionAlso: Expressive writing | Behavioural | Expressive writing condition |
Primary outcome
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
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.
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.
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction and Expressive writing condition in people with Breast Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress (time frame: Baseline to 8 week follow-up change). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.