Breast CancerNCT01591915
A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
A study testing MBSR in people with Breast Cancer, run by Skaraborg Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MBSR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2010to Dec 2020
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy
Who cannot join
- patients with advanced illness at diagnosis
- patients previously used MBSR
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer
- Conditions
- Breast Cancer
- Being tested
- MBSR
- Keywords
- Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSROther
Participants in Intervention 1 and Intervention 2 will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 min sessions, 6 days/week. Participants will be provided information material including a book of 20 pages introduction to mindfulness training, self-instructing CD, diary and training program. Only participants in Intervention 1 will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 h. Led by a certified MBSR instructor, these weekly group sessions are focused on participant's experiences of mindfulness, and include yoga and meditation training. Four registered nurses, skilled in patient learning, have been educated as certified MBSR instructors.
| Study group | Role | What they receive |
|---|---|---|
| MBSR self care program including weekly sessions | Experimental | Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Participants will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 hours. Receives: Other: MBSR |
| MBSR self care program | Experimental | Participants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Receives: Other: MBSR |
| Standard care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Mindfulness Based Stress Reduction on mood disorders
Measured: up to 5 years follow up
Secondary outcomes (1)
Coping capacity and health-related quality of life
Measured: up to 5 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skaraborg Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elisabeth Kenne Sarenmalm, Skaraborg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591915
- Sponsor's protocol ID
- 499-09
- Status last verified
- Apr 2016
- First submitted
- 2 May 2012
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kenne Sarenmalm E, Martensson LB, Holmberg SB, Andersson BA, Oden A, Bergh I. Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complement Altern Med. 2013 Oct 2;13:248. doi: 10.1186/1472-6882-13-248.
PubMed 24088535
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Mindfulness Based Stress Reduction Intervention in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT01591915
- Acronym / sponsor ID
- 499-09
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Mindfulness Based Stress Reduction, RCT, mood, cooping, health related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Skaraborg HospitalOther government
- Study start
- Jan 2010
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 4 May 2012 (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 purpose of this study is to evaluate the effect of mindfulness based stress reduction intervention in women with breast cancer
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MBSR self care program including weekly sessions | Experimental | Other: MBSRParticipants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. Participants will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 hours. |
| MBSR self care program | Experimental | Other: MBSRParticipants will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 minutes sessions, 6 days/week. |
| Standard care | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with breast cancer after completion of adjuvant chemotherapy or radiation therapy, with/or without endocrine therapy
Key exclusion criteria (2 listed)
- patients with advanced illness at diagnosis
- patients previously used MBSR
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 |
|---|---|---|
| MBSRParticipants in Intervention 1 and Intervention 2 will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 min sessions, 6 days/week. Participants will be provided information material including a book of 20 pages introduction to mindfulness training, self-instructing CD, diary and training program. Only participants in Intervention 1 will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 h. Led by a certified MBSR instructor, these weekly group sessions are focused on participant's experiences of mindfulness, and include yoga and meditation training. Four registered nurses, skilled in patient learning, have been educated as certified MBSR instructors. | Other | MBSR self care program, MBSR self care program including weekly sessions |
Primary outcome
The efficacy of Mindfulness Based Stress Reduction on mood disorders
Time frame: up to 5 years follow up
1 secondary outcome
Coping capacity and health-related quality of life
Time frame: up to 5 years follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Derived from this study: PubMed 24088535Kenne Sarenmalm E, Martensson LB, Holmberg SB, Andersson BA, Oden A, Bergh I. Mindfulness based stress reduction study design of a longitudinal randomized controlled complementary intervention in women with breast cancer. BMC Complement Altern Med. 2013 Oct 2;13:248. doi: 10.1186/1472-6882-13-248.
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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 MBSR in people with Breast Cancer, run by Skaraborg Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 2 May 2016. 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?
Results are not available in the source record.
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?
The efficacy of Mindfulness Based Stress Reduction on mood disorders (time frame: up to 5 years follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01591915, which also lists 1 linked publication.
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 2 May 2016.