Breast Cancer FemaleNCT03575624
Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors
A study testing Nutritional and goal-setting education, yoga in people with Breast Cancer Female and Survivorship, run by Mount Mary University at 1 site in United States.
Trial summary
The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female, Survivorship
- What is being tested?
- Nutritional and goal-setting education, yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2017to 15 Jun 2017
- 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
- Sex: female
- Race: African American
- Survivor of breast cancer
- Physical activity participation not limited by medical doctor
- English speaking
Who cannot join
- Sex: male
- Race: not African American
- No breast cancer history
- Physical activity limitations imposed by medical doctor
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding
Read the detailed description
Social and environmental issues continue to impact disease morbidity and mortality resulting in the inequities of health, wellness, and quality of life experienced by African American breast cancer survivors (AABCS) living in urban Milwaukee. AABCS outcomes in Milwaukee are significantly worse (OR=1.55) than those of Caucasian survivors.
The American Diabetes Association/American Cancer Society expert committee recommends the promotion of a healthy diet, physical activity, and weight management with low waist circumference to prevent diabetes, cancer, and obesity and to extend life expectancy. According to the National Health Interview Survey, 56% of African Americans are inactive. Yoga is one way to increase physical activity while improving wellness and health in AABCS.
The investigator's goal was to facilitate improved self-care efficacy through evidence-based integrative health and wellness strategies to help families overcome the effects of multiple negative, deep-rooted social determinants.
- Conditions
- Breast Cancer Female, Survivorship
- Being tested
- Nutritional and goal-setting education, yoga
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and goal-setting education, yogaBehavioural
This integrative program series, Live Well, was delivered bi-weekly from January-May 2017, by an interdisciplinary team of a registered nurse, occupational therapist/researcher, registered dietitian, and certified yoga instructor.
Session experiences were designed to build:
Sisterhood for health promotion and support, Individual and group health promotion through goal-setting, Healthy family nutrition and meal planning skills , Family integrated yoga practice
| Study group | Role | What they receive |
|---|---|---|
| Nutrition, goal-setting, yoga | Experimental | Behavioral: Nutritional and goal-setting education, yoga to promote achievement of change in health behaviors. SMART goal setting was used to guide nutritional and physical activity change to decrease disease risk and promote well-being. Receives: Behavioral: Nutritional and goal-setting education, yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central adiposity
circumferential measurement of waist
Measured: 20 weeks
Secondary outcomes (5)
Independent yoga posture series
participant independently demonstrates series of 6 postures
Measured: 20 weeks
Change in body weight
weight in pounds
Measured: 20 weeks
Change in balance
Time in seconds in single-leg stance
Measured: 20 weeks
independent healthy meal preparation
participant brings dish prepared from intervention recipe focusing on nutrition
Measured: Post intervention, after 20 weeks
Goal setting
Participant independently writes SMART (specific, measureable,attainable , reasonable, timely)
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start26 Jan 2017
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm model.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Mary University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie H Hunley, PhD, Principal investigator, Mount Mary University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575624
- Sponsor's protocol ID
- 20170126
- Status last verified
- Jun 2018
- First submitted
- 10 May 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Beyer KM, Zhou Y, Matthews K, Hoormann K, Bemanian A, Laud PW, Nattinger AB. Breast and Colorectal Cancer Survival Disparities in Southeastern Wisconsin. WMJ. 2016 Feb;115(1):17-21.
PubMed 27057575Garg SK, Maurer H, Reed K, Selagamsetty R. Diabetes and cancer: two diseases with obesity as a common risk factor. Diabetes Obes Metab. 2014 Feb;16(2):97-110. doi: 10.1111/dom.12124. Epub 2013 Jun 12.
PubMed 23668396NCHS, National Health Interview Survey, 2016, Sample Adult Core component retrieved online https://www.cdc.gov/nchs/data/nhis/earlyrelease/EarlyRelease201803_07.pdf
Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
PubMed 17785709
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Health Behaviors to Manage Chronic Conditions in Community-dwelling African American Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03575624
- Acronym / sponsor ID
- 20170126
- Conditions
- Breast Cancer Female, Survivorship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mount Mary UniversityUniversity, hospital or other
- Study start
- 26 Jan 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 2 Jul 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.
The purpose of this project was to test the efficacy of partnering with a community-led wellness program to reduce disease risk and increase wellness among breast cancer survivors. Information gathered will serve the dual purpose of testing intervention effectiveness and providing the community organization data to be used to secure sustainability funding
Detailed description
Social and environmental issues continue to impact disease morbidity and mortality resulting in the inequities of health, wellness, and quality of life experienced by African American breast cancer survivors (AABCS) living in urban Milwaukee. AABCS outcomes in Milwaukee are significantly worse (OR=1.55) than those of Caucasian survivors.
The American Diabetes Association/American Cancer Society expert committee recommends the promotion of a healthy diet, physical activity, and weight management with low waist circumference to prevent diabetes, cancer, and obesity and to extend life expectancy. According to the National Health Interview Survey, 56% of African Americans are inactive. Yoga is one way to increase physical activity while improving wellness and health in AABCS.
The investigator's goal was to facilitate improved self-care efficacy through evidence-based integrative health and wellness strategies to help families overcome the effects of multiple negative, deep-rooted social determinants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm model.
| Arm | Type | Receives |
|---|---|---|
| Nutrition, goal-setting, yoga | Experimental | Behavioral: Nutritional and goal-setting education, yogaBehavioral: Nutritional and goal-setting education, yoga to promote achievement of change in health behaviors. SMART goal setting was used to guide nutritional and physical activity change to decrease disease risk and promote well-being. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sex: female
- Race: African American
- Survivor of breast cancer
- Physical activity participation not limited by medical doctor
- English speaking
Key exclusion criteria (4 listed)
- Sex: male
- Race: not African American
- No breast cancer history
- Physical activity limitations imposed by medical doctor
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 |
|---|---|---|
| Nutritional and goal-setting education, yogaThis integrative program series, Live Well, was delivered bi-weekly from January-May 2017, by an interdisciplinary team of a registered nurse, occupational therapist/researcher, registered dietitian, and certified yoga instructor. Session experiences were designed to build: Sisterhood for health promotion and support, Individual and group health promotion through goal-setting, Healthy family nutrition and meal planning skills , Family integrated yoga practice | Behavioural | Nutrition, goal-setting, yoga |
Primary outcome
Change in central adiposity
Time frame: 20 weeks
circumferential measurement of waist
5 secondary outcomes
Independent yoga posture series
Time frame: 20 weeks
Change in body weight
Time frame: 20 weeks
Change in balance
Time frame: 20 weeks
independent healthy meal preparation
Time frame: Post intervention, after 20 weeks
Goal setting
Time frame: 20 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 2 Jul 2018.
- Background: PubMed 27057575Beyer KM, Zhou Y, Matthews K, Hoormann K, Bemanian A, Laud PW, Nattinger AB. Breast and Colorectal Cancer Survival Disparities in Southeastern Wisconsin. WMJ. 2016 Feb;115(1):17-21.
- Background: PubMed 23668396Garg SK, Maurer H, Reed K, Selagamsetty R. Diabetes and cancer: two diseases with obesity as a common risk factor. Diabetes Obes Metab. 2014 Feb;16(2):97-110. doi: 10.1111/dom.12124. Epub 2013 Jun 12.
- BackgroundNCHS, National Health Interview Survey, 2016, Sample Adult Core component retrieved online https://www.cdc.gov/nchs/data/nhis/earlyrelease/EarlyRelease201803_07.pdf
- Background: PubMed 17785709Moadel AB, Shah C, Wylie-Rosett J, Harris MS, Patel SR, Hall CB, Sparano JA. Randomized controlled trial of yoga among a multiethnic sample of breast cancer patients: effects on quality of life. J Clin Oncol. 2007 Oct 1;25(28):4387-95. doi: 10.1200/JCO.2006.06.6027. Epub 2007 Sep 4.
- 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.
Julie H Hunley, PhD principal investigator
Mount Mary University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional and goal-setting education, yoga in people with Breast Cancer Female and Survivorship, run by Mount Mary University 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 5 inclusion and 4 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 Jul 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 central adiposity (time frame: 20 weeks). 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 NCT03575624, which also lists 4 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 2 Jul 2018.