Breast CancerC-MBSRNCT02840344
Couples-Based Mindfulness for Young Breast Cancer Survivors
A study testing Couples MBSR and Individual MBSR in people with Breast Cancer, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Couples MBSR and Individual MBSR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 16 Jul 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years to 45 years old when diagnosed with breast cancer
- Diagnosed with stage 0, I, II, III breast cancer
- within 1 to 6 years after diagnosis of breast cancer
- Married or unmarried and living together.
- Living anywhere in the United States
- Both members of the couple must understand, read, and speak English
- Both members of the couple must have regular access to email and willingness to use the Internet.
Who cannot join
- 1. Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.
Read the detailed description
Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.
- Conditions
- Breast Cancer
- Being tested
- Couples MBSR, Individual MBSR
- Keywords
- Couple Functioning, Stress Reduction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples MBSRBehavioural
Both members of the couple will be asked to participate in the weekly video sessions and activities.
Individual MBSRBehavioural
Only the young breast cancer survivor will participate in the weekly video sessions and activities.
| Study group | Role | What they receive |
|---|---|---|
| Couples MBSR | Experimental | Young breast cancer survivors and their partners take part in an 8-week Couples Mindfulness-Based Stress reduction (C-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor and partner will be asked to watch a video module, together, each week for a total of 8 weeks. The C-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts.
Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention. Receives: Behavioral: Couples MBSR |
| Individual MBSR | Active comparator | Young breast cancer survivors take part in an 8-week Individual Mindfulness-Based Stress reduction (I-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor will be asked to watch a video module each week for 8 weeks in a row. The I-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts.
Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention. Receives: Behavioral: Individual MBSR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in couple functioning measured by the Sexual Interest and Satisfaction Scale
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in couple functioning measured by the Interpersonal Mindfulness Scale
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Perceived Partner Responsiveness
This scale will be measured each week for the 8 weeks of the intervention
Measured: Baseline to 8 weeks
Secondary outcomes (7)
Change in anxiety scores measured by PROMIS -- Anxiety
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in depression scores measured by the PROMIS -- Depression
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in fatigue scores measured by PROMIS -- Fatigue
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Change in stress scores measured by the Perceived Stress Scale
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Changes in physical functioning measured by the PROMIS - Physical Function
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Changes in salivary cortisol biomarker to assess stress levels
Saliva will be analyzed for cortisol and summary scores will be calculated for each condition (no individual scores will be reported).
Measured: Baseline to 8 weeks
Changes in trait mindfulness measured by Mindful Attention and Awareness Scale
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Oct 2017
- Primary completion16 Jul 2018
- Study completion16 Jul 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 University of Missouri-ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Missouri, St. Louis, University of Missouri, Kansas City
- Responsible party
- Principal investigator, Ann Bettencourt, University of Missouri-Columbia
- Investigators
- Ann Bettencourt, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840344
- Sponsor's protocol ID
- 2003808
- Acronym
- C-MBSR
- Status last verified
- Oct 2018
- First submitted
- 29 Jun 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples-Based Mindfulness for Young Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02840344
- Acronym / sponsor ID
- C-MBSR / 2003808
- Conditions
- Breast Cancer
- Keywords
- Couple Functioning, Stress Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- University of Missouri, St. Louis, University of Missouri, Kansas City
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 21 Jul 2016 (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.
This study aims to improve relationship, psychological, and physical adjustment among young breast cancer survivors (YBCS; diagnosed at age 45 or younger) and their committed/life partners. A mindfulness-based stress reduction (MBSR) intervention has been designed to meet the specific needs for young breast cancer survivors and their partners. The intervention will be administered in your home by using recorded videos of a trained MBSR instructor. Before, during, and after the 8-week intervention, participants will be asked to complete surveys.
Detailed description
Participants will be young breast cancer survivors (YBCS) and their partners. Young breast cancer survivors are those diagnosed at age 45 or younger. This study includes stress reducing interventions known to have a positive influence on physical and psychological functioning that will be administered through recorded videos. The interventions include watching an hour-long video stress-reduction class, each week, for 8 weeks and practicing guided meditations. YBCS participants will be randomly assigned to either an 8-week mindfulness-based stress reduction course designed for couples (C-MBSR) or an 8-week mindfulness-based stress reduction course for individuals. At the end of the study all participants (regardless of what assignment) will receive both sets of stress-reducing videos. Partners of the YBCS assigned to the couples condition will also be asked to watch the 8 C-MBSR videos. Some young breast cancer survivor participants and their partners will be asked to complete provide salivary cortisol and all survivors and partners will be asked to complete the 4 surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples MBSR | Experimental | Behavioral: Couples MBSRYoung breast cancer survivors and their partners take part in an 8-week Couples Mindfulness-Based Stress reduction (C-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor and partner will be asked to watch a video module, together, each week for a total of 8 weeks. The C-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts. Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention. |
| Individual MBSR | Active comparator | Behavioral: Individual MBSRYoung breast cancer survivors take part in an 8-week Individual Mindfulness-Based Stress reduction (I-MBSR) intervention. The course will be taught through recorded videos of a trained MBSR instructor. The young breast cancer survivor will be asked to watch a video module each week for 8 weeks in a row. The I-MBSR course consists of practicing mindful stress reduction techniques and filling out handouts. Both members of the couple will be asked to complete surveys assessing primary and secondary outcome measures administered at baseline and after final session. Participants will be asked to provide a Salivary Cortisol sample at baseline and after the 8th session. Follow up Surveys will be administered at one and three months after intervention. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18 years to 45 years old when diagnosed with breast cancer
- Diagnosed with stage 0, I, II, III breast cancer
- within 1 to 6 years after diagnosis of breast cancer
- Married or unmarried and living together.
- Living anywhere in the United States
Key exclusion criteria (1 listed)
- 1. Neither members of the couple may be experienced meditators (20 minutes daily, 5 days a week or more, for over a year) or graduates of a former MBSR class.
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 |
|---|---|---|
| Couples MBSRBoth members of the couple will be asked to participate in the weekly video sessions and activities. | Behavioural | Couples MBSR |
| Individual MBSROnly the young breast cancer survivor will participate in the weekly video sessions and activities. | Behavioural | Individual MBSR |
Primary outcome
Change in couple functioning measured by the Measured by the Dyadic Adjustment Scale
Time frame: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Change in couple functioning measured by the Measured by the Autonomy and Relatedness Inventory
Time frame: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Change in couple functioning measured by the Sexual Interest and Satisfaction Scale
Time frame: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Change in couple functioning measured by the Interpersonal Mindfulness Scale
Time frame: Baseline to 6 months
The scale scores will be the average of items in the measure. The scale scores will be averaged to create a summary score for each condition (no individual scores will be reported).
Perceived Partner Responsiveness
Time frame: Baseline to 8 weeks
This scale will be measured each week for the 8 weeks of the intervention
7 secondary outcomes
Change in anxiety scores measured by PROMIS -- Anxiety
Time frame: Baseline to 6 months
Change in depression scores measured by the PROMIS -- Depression
Time frame: Baseline to 6 months
Change in fatigue scores measured by PROMIS -- Fatigue
Time frame: Baseline to 6 months
Change in stress scores measured by the Perceived Stress Scale
Time frame: Baseline to 6 months
Changes in physical functioning measured by the PROMIS - Physical Function
Time frame: Baseline to 6 months
Changes in salivary cortisol biomarker to assess stress levels
Time frame: Baseline to 8 weeks
Changes in trait mindfulness measured by Mindful Attention and Awareness Scale
Time frame: Baseline to 6 months
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 17 Oct 2018.
- Individual participant dataSharing planned: No
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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.
Ann Bettencourt, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples MBSR and Individual MBSR in people with Breast Cancer, run by University of Missouri-Columbia at 1 site in United States.
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 7 inclusion and 1 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 17 Oct 2018. 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 United States. 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 couple functioning measured by the Measured by the Dyadic Adjustment Scale (time frame: Baseline to 6 months). The study lists 5 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 17 Oct 2018.