Breast CancerNCT02279303
Rx for Better Breast Health
A study testing Dietary Intervention in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females 18 years or older
- Primary diagnosis of breast cancer
- Fluency in English
- B.M.I. >= 30
- Available for follow-up for 12 months
Who cannot join
- Clinical evidence of metastatic disease
- Not diagnosed with primary breast cancer
- Lack fluency in English
- B.M.I. < 30
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Prescription for Better Breast Health
This randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.
Read the detailed description
The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.
- Conditions
- Breast Cancer
- Being tested
- Dietary Intervention, Dietary Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary InterventionBehavioural
Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.
Dietary ControlBehavioural
Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention | Experimental | Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Receives: Behavioral: Dietary Intervention |
| Dietary Control | Active comparator | Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Receives: Behavioral: Dietary Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieve USDA-recommended dietary intake based on five major food groups
The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.
Measured: 12 months
Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up
We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.
Measured: 12 months
Comparison of Interleukin (IL) pro-inflammatory biomarkers
We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.
Measured: 12 months
Comparison of Interleukin (IL) anti-inflammatory biomarkers
We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.
Measured: 12 months
Comparison of C-Reactive Protein (CRP)
We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.
Measured: 12 months
Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)
We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2017
- Study completionDec 2017
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 The University of Texas Health Science Center at San AntonioThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Principal investigator, Amelie Ramirez, The University of Texas Health Science Center at San Antonio
- Investigators
- Amelie Ramirez, DRPH, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279303
- Sponsor's protocol ID
- HSC20140150H
- Status last verified
- Jan 2018
- First submitted
- 15 Oct 2014
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription for Better Breast Health
- ClinicalTrials.gov ID
- NCT02279303
- Acronym / sponsor ID
- HSC20140150H
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Apr 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Oct 2014 (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 randomized controlled trial will test the impact of a patient-navigated, anti-inflammatory, culinary-based intervention (reinforced by motivational interviewing [MI] and tailored newsletters) on obese (body mass index [BMI] 30+), early-stage (0-IIIA) breast cancer survivors compared to a control group.
Detailed description
The investigators will recruit English-speaking, early-stage breast cancer survivors (N=200) to a two-arm randomized controlled trial (RCT) involving a 2 (group) by 3 (time) repeated measures design. The intervention will stimulate dietary behavior changes using individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. Groups will be compared at baseline and 6- and 12-month follow-up. Dependent measures will include dietary behavior and levels of cancer-associated biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention | Experimental | Behavioral: Dietary InterventionParticipants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. |
| Dietary Control | Active comparator | Behavioral: Dietary ControlControl participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females 18 years or older
- Primary diagnosis of breast cancer
- Fluency in English
- B.M.I. >= 30
- Available for follow-up for 12 months
Key exclusion criteria (4 listed)
- Clinical evidence of metastatic disease
- Not diagnosed with primary breast cancer
- Lack fluency in English
- B.M.I. < 30
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 |
|---|---|---|
| Dietary InterventionParticipants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change. | Behavioural | Dietary Intervention |
| Dietary ControlControl participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments. | Behavioural | Dietary Control |
Primary outcome
Achieve USDA-recommended dietary intake based on five major food groups
Time frame: 12 months
The USDA has published dietary intake guidelines for 5 major food groups. We will create a composite score ("yes" vs. "no") describing whether ss achieve designated levels of dietary intake for all five food groups. We will compare proportions of study and control women achieving this target at 12-month follow-up controlling for baseline values.
Intervention versus Control group comparison of circulating Adipose Stromal Cells (ASCs) at follow-up
Time frame: 12 months
We will compare participant (intervention) versus control levels of circulating Adipose Stromal Cells (ASCs) at 12-month follow-up. Participant levels of ASCs will be significantly lower than controls, controlling for baseline values.
Comparison of Interleukin (IL) pro-inflammatory biomarkers
Time frame: 12 months
We will compare participant versus control levels of Interleukins IL3, IL6, IL8 at 12-month follow-up. Participant levels of IL3, IL6, and IL8 will be significantly lower than controls, controlling for baseline values.
Comparison of Interleukin (IL) anti-inflammatory biomarkers
Time frame: 12 months
We will compare participant versus control levels of Interleukin IL10 at 12-month follow-up. Participant levels of IL10 will be significantly lower than controls, controlling for baseline values.
Comparison of C-Reactive Protein (CRP)
Time frame: 12 months
We will compare participant versus control levels of C-Reactive Protein (CRP) at 12-month follow-up. Participant levels of CRP will be significantly lower than controls, controlling for baseline values.
Comparison of Tumor Necrosis Factor-alpha (TNF-alpha)
Time frame: 12 months
We will compare participant versus control levels of Tumor Necrosis Factor-alpha (TNF-alpha) at 12-month follow-up. Participant levels of TNF-alpha will be significantly lower than controls, controlling for baseline values.
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 23 Jan 2018.
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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.
Amelie Ramirez, DRPH principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Intervention in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio 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 23 Jan 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?
Achieve USDA-recommended dietary intake based on five major food groups (time frame: 12 months). 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?
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 23 Jan 2018.