Breast CancerNCT04504201
Patient-centered Communication About Healthy Weight in Early Breast Cancer
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Focus Group
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2020to 29 Sep 2020
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast Cancer patients and Breast oncology providers will be eligible for this study
Who may be able to join
- Age 21 or older
- Diagnosed with early breast cancer, Stages I-III
- Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years
- Body mass Index of equal or greater than 30
- Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN
- associated with community-based practices
Who cannot join
- Cannot understand and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer
Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.
Read the detailed description
The overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "Patient-Center Communication about Healthy Weigh in clinical practice
Primary Objective:
- Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups Secondary Objective
- Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.
- Conditions
- Breast Cancer
- Being tested
- Focus Group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.
| Study group | Role | What they receive |
|---|---|---|
| Early Breast Cancer Patients | Early breast cancer patients (Stage I-III) who have completed primary treatment with a current Body mass index (BMI) over 30. Receives: Other: Focus Group | |
| Medical Oncology Clinicians | Oncology providers associated with community-based practices Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feedback from patients regarding healthy weight communication through focus groups
Summary of conversation based on 5A's Behavioral Change Model
Measured: 3 year
Secondary outcomes (1)
Feedback from oncology providers regarding healthy weight communication through semi-structured interview
Provider suggestions on how to implement 5A's Behavioral change model into patient care
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start15 Jun 2020
- Primary completion29 Sep 2020
- Study completion29 Sep 2020
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 UNC Lineberger Comprehensive Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Pfizer
- Responsible party
- Sponsor
- Investigators
- Kirsten Nyrop, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04504201
- Sponsor's protocol ID
- LCCC 1954
- Status last verified
- Jul 2022
- First submitted
- 4 Aug 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-based "Patient-Centered Communication About Healthy Weight" (PCC-HW) in a Diverse Sample of Women With Early Breast Cancer
- ClinicalTrials.gov ID
- NCT04504201
- Acronym / sponsor ID
- LCCC 1954
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Pfizer
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 7 Aug 2020 (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.
Comorbidities in breast cancer survival account for 49% of overall survival difference between black and white women. Many obesity-related comorbidities disproportionately affect black women, therefore pointing to a need to address obesity related comorbidities in survival disparities in early breast cancer patients. This study tinvestigates how messages and messaging about healthy weight can be tailored for racially diverse breast cancer survivors with obesity in order to ensure that clinic-based communications between patients and their oncology provider are patient-centered and culturally sensitive.
Detailed description
The overall goal of this research is to collect essential input for the future development of a quality improvement intervention to foster "Patient-Center Communication about Healthy Weigh in clinical practice
Primary Objective:
- Understand patient-centered perspectives on health weight communication with oncology clinicians by conducting focus groups Secondary Objective
- Understand oncology clinician perspectives on patient center communications for healthy weight interactions through semi-structured interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Breast Cancer Patients | – | Other: Focus GroupEarly breast cancer patients (Stage I-III) who have completed primary treatment with a current Body mass index (BMI) over 30. |
| Medical Oncology Clinicians | – | Other: Focus GroupOncology providers associated with community-based practices |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patients and Breast oncology providers will be eligible for this study
Key inclusion criteria (6 listed)
- Age 21 or older
- Diagnosed with early breast cancer, Stages I-III
- Completed primary treatment (Surgery, chemotherapy, radiation) within past 2 years
- Body mass Index of equal or greater than 30
- Breast cancer oncology provider in North Carolina with MD/DO/PA/NP/RN
Key exclusion criteria (1 listed)
- Cannot understand and speak English
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 |
|---|---|---|
| Focus GroupBreast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight. | Other | Early Breast Cancer Patients, Medical Oncology Clinicians |
Primary outcome
Feedback from patients regarding healthy weight communication through focus groups
Time frame: 3 year
Summary of conversation based on 5A's Behavioral Change Model
1 secondary outcome
Feedback from oncology providers regarding healthy weight communication through semi-structured interview
Time frame: 3 year
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 Jul 2022.
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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.
Kirsten Nyrop, PhD principal investigator
University of North Carolina, Chapel Hill
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 Cancer, run by UNC Lineberger Comprehensive Cancer 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 6 inclusion and 1 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 Jul 2022. 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?
Feedback from patients regarding healthy weight communication through focus groups (time frame: 3 year). 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 29 Jul 2022.