Breast CancerNCT01601548
Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
A study testing Mindfulness Based Cancer Recovery in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Ovarian Cancer
- What is being tested?
- Mindfulness Based Cancer Recovery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2013
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I-III breast cancer, gynecologic cancer or colorectal cancer
- Cancer survivor at least 18 years of age at the time of study enrollment
- Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed)
Who cannot join
- Psychologic disease in which informed consent cannot be obtained from the subject
- Need for ongoing chemotherapy and/or radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.
Read the detailed description
MBCR is a step wise standardized behavioral intervention of MBSR. The program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. During class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. In addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. A full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer
- Being tested
- Mindfulness Based Cancer Recovery
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cancer RecoveryBehavioural
Defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being. MBCR is a psycho-educational program developed by Dr. Linda Carlson. It is a step by step mindful-based stress reduction program (MBSR) designed to help cancer patients cope with their cancer diagnosis and treatment
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Subjects are randomized to the Mindfulness Based Cancer Recovery (MBSR) intervention. Participants are presented with mindfulness medication techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. A full day silent retreat will occur in the second half of the course, providing an opportunity for class participants to gain experience with mindfulness techniques. Receives: Behavioral: Mindfulness Based Cancer Recovery |
| Control Arm | No intervention | No intervention is administered. Health-related quality of life questionnaires will be completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Medical Outcomes Study Scores - Intervention versus Control
MOS SF-36: Medical Outcomes Study 36-Item Short-Form
Measured: Day 1, Week 8 and 4 Month Follow-Up
Secondary outcomes (7)
Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control
FACT-F: Functional Assessment in Cancer Therapy - Fatigue
Measured: Day 1, Week 8 and 4 Month Follow-Up
Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control
PSQI: Pittsburgh Sleep Quality Index
Measured: Day 1, Week 8 and 4 Month Follow-Up
Change in State-Trait Anxiety Inventory Scores - Intervention versus Control
20-item State-Trait Anxiety Inventory
Measured: Day 1, Week 8 and 4 Month Follow-Up
Comparison of Sexual Functioning Scale Scores - Intervention versus Control
MOS Sexual Functioning Scale
Measured: Day 1, Week 8 and 4 Month Follow-Up
Change in Self-Compassion Scale Scores - Intervention versus Control
SCS-SF: Self-Compassion Scale - Short Form
Measured: Day 1, Week 8 and 4 Month Follow-Up
Change in Self-Collected Information - Intervention versus Control
Self collected and self-report information regarding weekly meditation practice time, recorded class attendance and information from participants regarding barriers and challenges to practice, and perceived benefits to practice will be collected.
Measured: Day 1, Week 8 and 4 Month Follow-Up
Change in Number of Natural Killer Cells - Intervention versus Control
Measured: Day 1, Week 8 and 4 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 posted18 May 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
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 Masonic Cancer Center, University of MinnesotaThe 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
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Blaes, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601548
- Sponsor's protocol ID
- 2012NTLS014
- Status last verified
- Nov 2017
- First submitted
- 24 Apr 2012
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer and Mindfulness-Based Cancer Recovery After Chemotherapy
- ClinicalTrials.gov ID
- NCT01601548
- Acronym / sponsor ID
- 2012NTLS014
- Conditions
- Breast Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 18 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.
Upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. Mindfulness Based Cancer Recovery (MBCR) is a type of mind-body intervention. Mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.
Detailed description
MBCR is a step wise standardized behavioral intervention of MBSR. The program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. During class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. In addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. A full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Mindfulness Based Cancer RecoverySubjects are randomized to the Mindfulness Based Cancer Recovery (MBSR) intervention. Participants are presented with mindfulness medication techniques and share their experiences related to these meditation practices. There is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. A full day silent retreat will occur in the second half of the course, providing an opportunity for class participants to gain experience with mindfulness techniques. |
| Control Arm | No intervention | –No intervention is administered. Health-related quality of life questionnaires will be completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stage I-III breast cancer, gynecologic cancer or colorectal cancer
- Cancer survivor at least 18 years of age at the time of study enrollment
- Completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed)
Key exclusion criteria (2 listed)
- Psychologic disease in which informed consent cannot be obtained from the subject
- Need for ongoing chemotherapy and/or radiation therapy
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 Cancer RecoveryDefined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being. MBCR is a psycho-educational program developed by Dr. Linda Carlson. It is a step by step mindful-based stress reduction program (MBSR) designed to help cancer patients cope with their cancer diagnosis and treatment | Behavioural | Intervention Arm |
Primary outcome
Change in Medical Outcomes Study Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
MOS SF-36: Medical Outcomes Study 36-Item Short-Form
7 secondary outcomes
Change in Functional Assessment in Cancer Therapy Fatigue Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Change in Pittsburgh Sleep Quality Index Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Change in State-Trait Anxiety Inventory Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Comparison of Sexual Functioning Scale Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Change in Self-Compassion Scale Scores - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Change in Self-Collected Information - Intervention versus Control
Time frame: Day 1, Week 8 and 4 Month Follow-Up
Change in Number of Natural Killer Cells - Intervention versus Control
Time frame: Day 1, Week 8 and 4 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 2 Dec 2017.
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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.
Anne Blaes, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
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 Cancer Recovery in people with Breast Cancer and Colorectal Cancer, run by Masonic Cancer Center, University of Minnesota 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 3 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 2 Dec 2017. 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 Medical Outcomes Study Scores - Intervention versus Control (time frame: Day 1, Week 8 and 4 Month Follow-Up). 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 2 Dec 2017.