Breast CancerNCT03652935

Mindfulness, Breast Cancer and Psycho-Immune Dysregulation

A study testing Mindfulness Based Stress Reduction and Health Education Series in people with Breast Cancer, run by Loyola University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 28 to 75 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: Mindfulness Based Stress Reduction and Health Education Series
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: No sites listed yet
Study dates: 15 Sep 2008to 16 Dec 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 28 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women
Early Stage Breast Cancer

Who cannot join

Prior training in MBSR,
Recurrent breast cancer,
Metastatic breast cancer,
Other cancers (except basal cell carcinoma),
Immune-based disease,
Psychoses,

Show all 10Show fewer

Cognitive dysfunction,
Unable to read or write English,
History of substance abuse,
Use of immune-altering medications

About this study

Official title: Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation

The purpose of this study is to evaluate the benefits of a Mindfulness Based Stress Reduction (MBSR) program for psycho-immune dysregulation in women newly diagnosed with breast cancer compared to women with breast cancer completing an attention control condition (health education classes). Women will be randomized to either the MBSR or health education classes. They will complete psychometric instruments evaluating psychological outcomes and will provide blood samples for immune outcomes. They will also provide saliva samples for cortisol diurnal rhythm determination. Measures will be done longitudinally pre and post MBSR or health education program. It is hypothesized that MBSR participants will exhibit improved psychological and immunological outcomes over time, as compared to women randomized to the health education classes.

Read the detailed description

The Mindfulness-Based Stress Reduction (MBSR) program is designed to cultivate conscious awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner (Kabat-Zinn, et al., 1990). Mindfulness programs may facilitate recovery from cancer. However, most prior mindfulness investigations for women with breast cancer focused on cancer survivors, well beyond the acute period of cancer diagnosis and treatment. Moreover, few of these studies evaluated immune measures with relevance to cancer.

Women diagnosed with early stage breast cancer (Stages 0, 1, 2, and 3) will be enrolled. Eligible women will be identified after completion of their breast surgery and when surgical pathology reports are available. Women will complete psychometric instruments and study questionnaires. They will provide blood for immune measures and saliva for cortisol diurnal rhythm. Measures will be done at five separate time points. These are pre-, mid-, and completion of either the MBSR or the attention control program, as well as at 1- and 6-months post-program. Demographic information and information about health behaviors will be collected by self-report. Wrist actigraphy for an additional assessment of sleep quality will be done in an exploratory manner. Hierarchical linear modeling will be used to compute multilevel model for change, based on full maximum likelihood estimation (Raudenbush, S. W., and A. S. Bryk. 2002). Hierarchical linear modeling will be applied to examine intra-individual and inter-individual differences in initial status (baseline) and trajectories of change over time.

Conditions: Breast Cancer
Being tested: Mindfulness Based Stress Reduction, Health Education Series
Keywords: Breast cancer, mindfulness, immune, stress
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
Health Education SeriesOther
This is an active comparator condition that consists of 8 weekly classes related to health.

Study groups in NCT03652935
Study group	Role	What they receive
Mindfulness Based Stress Reduction	Experimental	The Mindfulness Based Stress Reduction (MBSR) program consists of an 8-week (2.5 hr/wk) program with a 6-hour silent mindful practice retreat after the fifth week. A licensed clinical psychologist, certified as an MBSR instructor, will provide instruction to all groups. Mindfulness will be taught using breath awareness, sitting and walking meditation, and mindful yoga. Participants will be given a standardized session-by-session program workbook containing weekly objectives and assignments, as well as two practice recordings and the book, Full Catastrophe Living (Kabat-Zinn, J, 1990). Receives: Behavioral: Mindfulness Based Stress Reduction
Health Education Series	Active comparator	The active comparator condition consists of an 8-week educational series, administered in group-format, and matched in duration and frequency to the MBSR program. Session topics include: 1) Understanding Breast Cancer and Risks for Breast Cancer, 2) Breast Cancer Treatment, 3) Communicating Effectively with your Health Care Providers; Keeping your Medical Records, 4) Genetic Testing and Cancer, 5) Nutrition and Cancer, (6) Cooking Demonstration, 7) Bone Health, and 8) Image and Cancer (American Cancer Society - Look Good, Feel Better). The program content and objectives were reviewed by four content experts (oncology clinicians) and two breast cancer survivors. Receives: Other: Health Education Series

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Natural Killer Cell Activity
Natural killer cell lytic activity (NKCA) against tumor targets will be assessed ex vivo using participant peripheral blood mononuclear cells (PBMC) in a standard chromium release assay, as we described previously (Witek-Janusek, L. et al., 2007).
Measured: Change from baseline NKCA to 36 weeks.
Change in Cytokine Levels
Plasma levels of cytokines, Interleukin 6 (IL-6) and Tumor Necrosis Factor (TNF) alpha and PBMC cytokine production of these cytokines and interferon (IFN) gamma will be determined. Measurement of individual cytokines will be by quantitative sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN), as we described previously (Witek-Janusek, L. et al., 2007; Witek-Janusek, et al., 2008).
Measured: Change from baseline cytokine level to 36 weeks.
Change in Perceived Stress
The construct, perceived stress, will be measured using the Perceived Stress Scale (Cohen, S. et al., 1983). The Perceived Stress Scale is a 10-item instrument that assesses the degree to which life experiences are appraised as uncontrollable. Individual items are summed, with scores ranging from 0 (minimum) to 40 (maximum); higher scores indicate higher perceived stress.
Measured: Change from baseline perceived stress level to 36 weeks.
Change in Depression
The construct, depression, will be measured using the Center for Epidemiologic Studies - Depression scale. This is a 20-item measure that asks individuals to rate how often over the past week they experienced symptoms associated with depression. Individual items are summed with scores ranging from 0 (minimum) to 60 (maximum); higher scores indicate greater depressive symptoms (Radloff, LS, 1977).
Measured: Change from baseline depression level to 36 weeks.
Change in Fatigue
The construct, fatigue, refers to a subjective sense of tiredness. Fatigue will be measured using the Multidimensional Fatigue Symptom Inventory-Short Form, which consists of 30 items that assess the extent of fatigue experienced by the respondent. Individual items are summed with scores ranging from -24 to 96. Higher score indicates greater fatigue (Stein, KD, et al., 2004).
Measured: Change from baseline fatigue level to 36 weeks.
Change in Sleep
The construct, sleep quality, will be measured using the Pittsburgh Sleep Quality Index, which consists of 19 items that measure a person's perception of their sleep quality. An overall score is calculated by summing items. Scores range from 0 (minimum) to 21 (maximum), where lower scores denote a better sleep quality (Buysse, DJ, et al., 1989).
Measured: Change from baseline sleep quality level to 36 weeks.

Secondary outcomes (5)

Change in Cortisol
Cortisol diurnal rhythm is determined by repeated measure of salivary cortisol (Kirschbaum, C and Hellhammer, DH. 1994). This allows frequent non-invasive sampling under everyday conditions. Subjects will collect saliva samples upon awakening (within 15 minutes of awakening), and at 1200, 1700, and 2200 hr on 2 consecutive days. Centrifuged samples will be frozen and assayed in duplicate using immunoassay kits (Salimetrics™), which measure biologically active (non-protein bound) cortisol.
Measured: Change from baseline cortisol level to 36 weeks.
Change in Quality of Life in Cancer
The construct, quality of life, will be measured using the Quality of Life Index Cancer Version III. Quality of life refers to "a person's sense of well-being that stems from satisfaction or dissatisfaction with the areas of life that are important to him/her." Items are summed to provide global quality of life, with score ranging from 0 (minimum) to 30 (maximum); higher scores indicate better quality of life (Ferrans, CE, 1990).
Measured: Change from baseline quality of life level to 36 weeks.
Change in Social Support
The construct of social support refers to the extent to which a person's social relationships provide support. Social support will be measured using the 24-item Social Provisions scale, which measures the degree of perceived social support. Responses to items are summed and scores range from 24 to 96;a higher score indicates a greater degree of perceived support (Cutrona CE and Russell DW,1987).
Measured: Change from baseline social support level to 36 weeks.
Change in Coping
The construct of coping with cancer will be measured using the Jalowiec Coping Scale. The Jalowiec Coping Scale is a 60 item self-report measure assessing efficacy of coping behaviors. The JCS allows for the respondent to identify which coping behaviors he/she uses and to then rate the effectiveness of that coping behavior. A score of coping effectiveness is calculated. Scores can theoretically range between 0 and 180, with higher scores indicating greater use of coping behaviors (Jalowiec A, et al., 1984).
Measured: Change from baseline to 36 weeks.
Change in Wrist Actigraphy Measure of Sleep Quality
Wrist Actigraphy will be used as a measure of sleep quality (Morgenthaler, T. et al. 2007). Women will be given an Actiwatch (Respironics) and asked to wear the Actiwatch for 6 days (non-dominate wrist). Actiwatch software will be used to calculate a composite of sleep quality.
Measured: Change from baseline actigraphy to 36 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 200816 Dec 2013

First posted29 Aug 2018
Study start15 Sep 2008
Primary completion16 Dec 2013
Study completion16 Dec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03652935
Sponsor's protocol ID: 200101
Status last verified: Aug 2018
First submitted: 26 Aug 2018
Last updated: 29 Aug 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
PubMed 17520797
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Cutrona CE and Russell DW. 1987. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1:37-6.
Ferrans CE. Development of a quality of life index for patients with cancer. Oncol Nurs Forum. 1990 May-Jun;17(3 Suppl):15-9; discussion 20-1.
PubMed 2342979
Jalowiec A, Murphy SP, Powers MJ. Psychometric assessment of the Jalowiec Coping Scale. Nurs Res. 1984 May-Jun;33(3):157-61.
PubMed 6563533
Kabat-Zinn, J. 1990. Full Catastrophe Living. Delacorte, New York.
Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. doi: 10.1016/0306-4530(94)90013-2.
PubMed 8047637
Radloff, LS 1977. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1:385-401. doi.org/10.1177/014662167700100306
Raudenbush, SW and Bryk, AS. 2002. Hierarchical Linear Models: Applications and Data Analysis Methods, 2 ed. Sage, Thousand Oaks, CA.
Stein KD, Jacobsen PB, Blanchard CM, Thors C. Further validation of the multidimensional fatigue symptom inventory-short form. J Pain Symptom Manage. 2004 Jan;27(1):14-23. doi: 10.1016/j.jpainsymman.2003.06.003.
PubMed 14711465
Witek-Janusek L, Gabram S, Mathews HL. Psychologic stress, reduced NK cell activity, and cytokine dysregulation in women experiencing diagnostic breast biopsy. Psychoneuroendocrinology. 2007 Jan;32(1):22-35. doi: 10.1016/j.psyneuen.2006.09.011. Epub 2006 Nov 7.
PubMed 17092654
Witek-Janusek L, Albuquerque K, Chroniak KR, Chroniak C, Durazo-Arvizu R, Mathews HL. Effect of mindfulness based stress reduction on immune function, quality of life and coping in women newly diagnosed with early stage breast cancer. Brain Behav Immun. 2008 Aug;22(6):969-81. doi: 10.1016/j.bbi.2008.01.012. Epub 2008 Mar 21.
PubMed 18359186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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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
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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation
ClinicalTrials.gov ID: NCT03652935
Acronym / sponsor ID: 200101
Conditions: Breast Cancer
Keywords: Breast cancer, mindfulness, immune, stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Study start: 15 Sep 2008 (actual)
Primary completion: 16 Dec 2013 (actual)
Study completion: 16 Dec 2013 (actual)
First posted: 29 Aug 2018 (actual)
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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness Based Stress Reduction	Experimental	Behavioral: Mindfulness Based Stress ReductionThe Mindfulness Based Stress Reduction (MBSR) program consists of an 8-week (2.5 hr/wk) program with a 6-hour silent mindful practice retreat after the fifth week. A licensed clinical psychologist, certified as an MBSR instructor, will provide instruction to all groups. Mindfulness will be taught using breath awareness, sitting and walking meditation, and mindful yoga. Participants will be given a standardized session-by-session program workbook containing weekly objectives and assignments, as well as two practice recordings and the book, Full Catastrophe Living (Kabat-Zinn, J, 1990).
Health Education Series	Active comparator	Other: Health Education SeriesThe active comparator condition consists of an 8-week educational series, administered in group-format, and matched in duration and frequency to the MBSR program. Session topics include: 1) Understanding Breast Cancer and Risks for Breast Cancer, 2) Breast Cancer Treatment, 3) Communicating Effectively with your Health Care Providers; Keeping your Medical Records, 4) Genetic Testing and Cancer, 5) Nutrition and Cancer, (6) Cooking Demonstration, 7) Bone Health, and 8) Image and Cancer (American Cancer Society - Look Good, Feel Better). The program content and objectives were reviewed by four content experts (oncology clinicians) and two breast cancer survivors.

Who may qualify

Ages: 28 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Women
Early Stage Breast Cancer

Key exclusion criteria (10 listed)

Prior training in MBSR,
Recurrent breast cancer,
Metastatic breast cancer,
Other cancers (except basal cell carcinoma),
Immune-based disease,

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 Reduction	Behavioural	Mindfulness Based Stress Reduction
Health Education SeriesThis is an active comparator condition that consists of 8 weekly classes related to health.	Other	Health Education Series

Primary outcome

Change in Natural Killer Cell Activity
Time frame: Change from baseline NKCA to 36 weeks.
Natural killer cell lytic activity (NKCA) against tumor targets will be assessed ex vivo using participant peripheral blood mononuclear cells (PBMC) in a standard chromium release assay, as we described previously (Witek-Janusek, L. et al., 2007).
Change in Cytokine Levels
Time frame: Change from baseline cytokine level to 36 weeks.
Plasma levels of cytokines, Interleukin 6 (IL-6) and Tumor Necrosis Factor (TNF) alpha and PBMC cytokine production of these cytokines and interferon (IFN) gamma will be determined. Measurement of individual cytokines will be by quantitative sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN), as we described previously (Witek-Janusek, L. et al., 2007; Witek-Janusek, et al., 2008).
Change in Perceived Stress
Time frame: Change from baseline perceived stress level to 36 weeks.
The construct, perceived stress, will be measured using the Perceived Stress Scale (Cohen, S. et al., 1983). The Perceived Stress Scale is a 10-item instrument that assesses the degree to which life experiences are appraised as uncontrollable. Individual items are summed, with scores ranging from 0 (minimum) to 40 (maximum); higher scores indicate higher perceived stress.
Change in Depression
Time frame: Change from baseline depression level to 36 weeks.
The construct, depression, will be measured using the Center for Epidemiologic Studies - Depression scale. This is a 20-item measure that asks individuals to rate how often over the past week they experienced symptoms associated with depression. Individual items are summed with scores ranging from 0 (minimum) to 60 (maximum); higher scores indicate greater depressive symptoms (Radloff, LS, 1977).
Change in Fatigue
Time frame: Change from baseline fatigue level to 36 weeks.
The construct, fatigue, refers to a subjective sense of tiredness. Fatigue will be measured using the Multidimensional Fatigue Symptom Inventory-Short Form, which consists of 30 items that assess the extent of fatigue experienced by the respondent. Individual items are summed with scores ranging from -24 to 96. Higher score indicates greater fatigue (Stein, KD, et al., 2004).
Change in Sleep
Time frame: Change from baseline sleep quality level to 36 weeks.
The construct, sleep quality, will be measured using the Pittsburgh Sleep Quality Index, which consists of 19 items that measure a person's perception of their sleep quality. An overall score is calculated by summing items. Scores range from 0 (minimum) to 21 (maximum), where lower scores denote a better sleep quality (Buysse, DJ, et al., 1989).

5 secondary outcomes

Change in Cortisol
Time frame: Change from baseline cortisol level to 36 weeks.
Change in Quality of Life in Cancer
Time frame: Change from baseline quality of life level to 36 weeks.
Change in Social Support
Time frame: Change from baseline social support level to 36 weeks.
Change in Coping
Time frame: Change from baseline to 36 weeks.
Change in Wrist Actigraphy Measure of Sleep Quality
Time frame: Change from baseline actigraphy to 36 weeks.

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 29 Aug 2018.
Background: PubMed 17520797Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
BackgroundCutrona CE and Russell DW. 1987. The provisions of social relationships and adaptation to stress. Advances in Personal Relationships. 1:37-6.
Background: PubMed 2342979Ferrans CE. Development of a quality of life index for patients with cancer. Oncol Nurs Forum. 1990 May-Jun;17(3 Suppl):15-9; discussion 20-1.
Background: PubMed 6563533Jalowiec A, Murphy SP, Powers MJ. Psychometric assessment of the Jalowiec Coping Scale. Nurs Res. 1984 May-Jun;33(3):157-61.
BackgroundKabat-Zinn, J. 1990. Full Catastrophe Living. Delacorte, New York.
Background: PubMed 8047637Kirschbaum C, Hellhammer DH. Salivary cortisol in psychoneuroendocrine research: recent developments and applications. Psychoneuroendocrinology. 1994;19(4):313-33. doi: 10.1016/0306-4530(94)90013-2.
BackgroundRadloff, LS 1977. The CES-D Scale: A self-report depression scale for research in the general population. Applied Psychological Measurement 1:385-401. doi.org/10.1177/014662167700100306
BackgroundRaudenbush, SW and Bryk, AS. 2002. Hierarchical Linear Models: Applications and Data Analysis Methods, 2 ed. Sage, Thousand Oaks, CA.
Background: PubMed 14711465Stein KD, Jacobsen PB, Blanchard CM, Thors C. Further validation of the multidimensional fatigue symptom inventory-short form. J Pain Symptom Manage. 2004 Jan;27(1):14-23. doi: 10.1016/j.jpainsymman.2003.06.003.
Background: PubMed 17092654Witek-Janusek L, Gabram S, Mathews HL. Psychologic stress, reduced NK cell activity, and cytokine dysregulation in women experiencing diagnostic breast biopsy. Psychoneuroendocrinology. 2007 Jan;32(1):22-35. doi: 10.1016/j.psyneuen.2006.09.011. Epub 2006 Nov 7.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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RecruitingPhase 2
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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
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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.

Linda Janusek, PhD principal investigator

Loyola University Chicago

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness Based Stress Reduction and Health Education Series in people with Breast Cancer, run by Loyola University.

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 10 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 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

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 Natural Killer Cell Activity (time frame: Change from baseline NKCA to 36 weeks.). The study lists 6 primary outcomes in all. 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 NCT03652935, which also lists 13 linked publications.

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 29 Aug 2018.