Breast NeoplasmsCARENCT02887196
Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment
An observational study of Breast Neoplasms and Body Weight Changes, run by Pennington Biomedical Research Center at 1 site in United States.
Trial summary
Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Body Weight Changes
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 18 Sep 2018
- Phase
- Observational
- 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
Study population: Community hospitals and physician offices in the Baton Rouge, LA area
Who may be able to join
- Female
- ≥18 years of age
- Diagnosed with stage I, II or III breast cancer with plans to undergo endocrine and/or chemotherapy treatment (radiation in combination with one or more of these therapies is acceptable)
- Willing to complete up to 4 clinic visits
Who cannot join
- Have received neoadjuvant therapy for current diagnosis
- Currently receiving adjuvant chemotherapy or other adjuvant therapy that was initiated prior to study enrollment
- History of cancer and neoplastic treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808-4124
About this study
Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . The primary goal of this pilot study is to investigate the physical and behavioral changes that occur in patients receiving treatment for breast cancer.
Read the detailed description
In this cross sectional, longitudinal, observational study, 25 women will be followed through their treatment for stage I-III breast cancer. The women will be asked to provide their opinions and desires for lifestyle intervention at four timepoints throughout treatment. In addition to qualitative data, basic clinical data will be collected (anthropometrics, vital signs, dietary intake, and physical activity). The primary goal of this pilot study is to investigate the anthropometric and behavioral changes that occur in patients undergoing adjuvant chemotherapy for breast cancer.
Aim 1: To better understand patients' attitudes toward and perceived barriers to nutrition and physical activity interventions during neoplastic treatment.
Hypothesis: Patients' reported attitudes, motivation, and perceived barriers will change throughout treatment.
Aim 2: To measure the physical and metabolic changes that occur throughout neoplastic treatment for breast cancer.
Hypothesis: Over 50% of the participants will gain body weight during treatment and metabolic parameters will trend with body weight change.
- Conditions
- Breast Neoplasms, Body Weight Changes
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms, Body Weight Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived attitudes towards lifestyle interventions
Qualitative data collected via semi-structured interview
Measured: 9 months
Secondary outcomes (3)
Diet
24 hour recall (ASA24) to assess food intake changes throughout treatment
Measured: 9 months
Physical Activity
Wrist worn Actigraph accelerometer to assess activity changes throughout treatment
Measured: 9 months
Body Weight
Body weight change throughout treatment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion11 Sep 2018
- Study completion18 Sep 2018
Why it stopped: Saturation of a particular breast cancer treatment regimen enrolled. We will need to reexamine inclusion/exclusion criteria in future studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Gilmore, Pennington Biomedical Research Center
- Investigators
- Anne Gilmore, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887196
- Sponsor's protocol ID
- PBRC 2016-050
- Acronym
- CARE
- Status last verified
- Jul 2021
- First submitted
- 29 Aug 2016
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment
- ClinicalTrials.gov ID
- NCT02887196
- Acronym / sponsor ID
- CARE / PBRC 2016-050
- Conditions
- Breast Neoplasms, Body Weight Changes
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Saturation of a particular breast cancer treatment regimen enrolled. We will need to reexamine inclusion/exclusion criteria in future studies.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 18 Sep 2018 (actual)
- First posted
- 2 Sep 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.
Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . The primary goal of this pilot study is to investigate the physical and behavioral changes that occur in patients receiving treatment for breast cancer.
Detailed description
In this cross sectional, longitudinal, observational study, 25 women will be followed through their treatment for stage I-III breast cancer. The women will be asked to provide their opinions and desires for lifestyle intervention at four timepoints throughout treatment. In addition to qualitative data, basic clinical data will be collected (anthropometrics, vital signs, dietary intake, and physical activity). The primary goal of this pilot study is to investigate the anthropometric and behavioral changes that occur in patients undergoing adjuvant chemotherapy for breast cancer.
Aim 1: To better understand patients' attitudes toward and perceived barriers to nutrition and physical activity interventions during neoplastic treatment.
Hypothesis: Patients' reported attitudes, motivation, and perceived barriers will change throughout treatment.
Aim 2: To measure the physical and metabolic changes that occur throughout neoplastic treatment for breast cancer.
Hypothesis: Over 50% of the participants will gain body weight during treatment and metabolic parameters will trend with body weight change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community hospitals and physician offices in the Baton Rouge, LA area
Key inclusion criteria (4 listed)
- Female
- ≥18 years of age
- Diagnosed with stage I, II or III breast cancer with plans to undergo endocrine and/or chemotherapy treatment (radiation in combination with one or more of these therapies is acceptable)
- Willing to complete up to 4 clinic visits
Key exclusion criteria (3 listed)
- Have received neoadjuvant therapy for current diagnosis
- Currently receiving adjuvant chemotherapy or other adjuvant therapy that was initiated prior to study enrollment
- History of cancer and neoplastic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived attitudes towards lifestyle interventions
Time frame: 9 months
Qualitative data collected via semi-structured interview
3 secondary outcomes
Diet
Time frame: 9 months
Physical Activity
Time frame: 9 months
Body Weight
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Saturation of a particular breast cancer treatment regimen enrolled. We will need to reexamine inclusion/exclusion criteria in future studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 Gilmore, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Body Weight Changes, run by Pennington Biomedical Research Center 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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 23 Jul 2021. 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 was stopped early (reason given: Saturation of a particular breast cancer treatment regimen enrolled. We will need to reexamine inclusion/exclusion criteria in future studies.). Results are not available in the source record.
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?
Perceived attitudes towards lifestyle interventions (time frame: 9 months). 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 Jul 2021.