Breast CancerYBCSSNCT05981716
Young Breast Cancer Survivors Study
An observational study of Breast Cancer, run by University of South Carolina at 1 site in United States.
Trial summary
Despite significant overall reductions in mortality rates for breast cancer over the past decade, both incidence and mortality rates have steadily climbed in adults diagnosed before age 50. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 384 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 31 Dec 2023
- 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 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: The investigators plan to enroll 384 women who were previously diagnosed with breast cancer prior to the age of 50 years.
Who may be able to join
- Non-institutionalized
- English literate
- Female breast cancer survivors
- Diagnosed with breast cancer within the past 10 years and diagnosed younger than age 50 years
Who cannot join
- Male breast cancer survivors
- Breast cancer survivors diagnosed with breast cancer after the age of 50 years
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Ella Gustafson, ellabg@email.sc.edu
About this study
Official title: Factors Affecting Quality of Life and Treatment Adherence Among Early-Age-at-Onset Breast Cancer Survivors
Despite significant overall reductions in mortality rates for breast cancer over the past decade, both incidence and mortality rates have steadily climbed in adults diagnosed before age 50. This research project addresses factors associated with quality of life among and treatment response in early-age-at-onset breast cancer patients. The overall objective is collect information from early-onset breast cancer patients using an online questionnaire and examine factors related to cancer survival, (i.e.,better quality of life, better treatment adherence, less adverse treatment responses).
Aim 1: Identify dietary patterns related to health-related quality of life in early-age-at-onset breast cancer patients. The investigators hypothesize that diet quality is related to better health-related quality of life among young breast cancer survivors.
Aim 2. Identify demographic, social determinants, and geographic factors associated with treatment adherence. The investigators hypothesize that social determinants such as poverty-to-income ratio, education, and proximity to cancer treatment facilities are associated with treatment adherence in early-onset breast cancer.
Read the detailed description
This is an observational epidemiologic study in which the investigators will collect data from approximately 384 participants at one point in time using online questionnaires (REDCaP and the NCI Diet History Questionnaire III). Recruitment will be conducted via breast cancer survivor social media support groups and advocacy groups. Electronic consent will be granted at the beginning of each online questionnaire. Data collection will occur via self-report in the location chosen by the participant using an online questionnaire. The investigators will use established validated questionnaires used by other previously conducted cohorts to enquire about demographics, occupation, cancer screening history, family history of cancer, comorbidities, cancer and other comorbidity treatment including fertility-related, HRQoL, dietary intake using the online NCI Dietary History Questionnaire III which includes dietary supplement use, residential history, hormonal status, physical activity, tobacco product and alcohol use, experiences with racism, social support, and information on health care utilization.
To accomplish Aim 1, the investigators will use the NCI Diet History Questionnaire III, an online 135-item food frequency questionnaire with 26 dietary supplement questions, reflecting the past one month of intake to estimate food and nutrient intakes and overall dietary patterns.Health related quality of life (HRQoL) is a multidimensional concept that not only includes physical, psychological and social domains, but may also encompass other domains such as cognitive functioning. Cancer patients also exhibit many symptoms (e.g., fatigue, pain, sleep disturbance) that are not measurable directly from laboratory tests. Thus, assessing HRQoL and these symptom burdens among cancer survivors will need to rely on patients' self-reports, measured by validated instruments especially for patients with breast cancer, and includes the Functional Assessment of Cancer Therapy (FACT-B).
Descriptive statistics will be presented as mean (standard deviation) and median (inter quartile range) for continuous variables and as frequency (percentage) for categorical variables. Data visualization tools such as histogram, boxplot, scatterplot and line plot will be employed to assess the trends and outliers in the data. Bivariate association between categorical variables will be tested for statistical significance using Chi-square test or exact test. Differences in continuous variables will be tested for statistical significance using Kruskal-Wallis test. HRQoL data typically are not distributed normally with left-skewed distributions and potential ceiling effects requiring consideration of alternative estimators in multivariate models. A number of different alternative models have been proposed over the standard ordinary least squares approach including beta regression, tobit regression, and two-part modeling. The investigators will assess the distribution of the primary HRQoL measures in building analytic models. With healthy dietary pattern as the primary independent variable and measures of HRQoL serving as primary dependent variable, the investigators expect to find that as diet quality increases, HRQoL increases.
For Aim 2, the investigators will ask study participants to complete questionnaires related to racism, fatalism, and demographics and the investigators will geocode residential histories of participants to measure the role of racism, fatalism, income, education, and proximity to treatment facilities in treatment adherence. The investigators will use geographic information systems to geocode participants' residential histories. Participants will be asked the ZIP code of residence at the time of diagnosis, as well as the ZIP code of the treatment facility in which they received care. If the ZIP code of the treatment facility is unknown, the participant can give the city and state, in which a ZIP code of the central point of the city will be found and used for analysis. Using Microsoft Excel, and the list of latitudes and longitudes by ZIP code, provided by the United States Census Bureau (find citation), the distance in miles between the place of residence and place of treatment will be determined. This distance calculation can be used to help evaluate treatment adherence and the distance to treatment. Residential histories will also be used to determine participant rurality. Regarding the many competing definitions and classification schemes for rurality, Hall et al. found dichotomous definitions mask heterogeneity relevant to health research and studies of accessibility. The investigators will instead use the Rural-Urban Commuting Area (RUCA) codes developed by the Office of Rural Health Policy of the Health Resources and Services Administration and the Economic Research Service of the United States Department of Agriculture (USDA). RUCA codes combine information on population density, urbanicity, and daily commuting patterns to classify census tracts into 22 distinct codes, which can then be consolidated into more manageable classifications.
Descriptive statistics will be presented as mean (standard deviation) and median (inter quartile range) for continuous variables and as frequency (percentage) for categorical variables. Data visualization tools such as histogram, boxplot, scatterplot and line plot will be employed to assess the trends and outliers in the data. The investigators will explore the associations between treatment adherence and each measure of social determinants (such as poverty to income ratio, racism, education, and proximity to treatment facility) using mixed effect logistic regression. The model will be sequentially adjusted for the effect of non-modifiable and modifiable confounders such as age, cancer stage, treatment type, and insurance status.
Recruitment of participants is expected to be ongoing for ~12 months.
- Conditions
- Breast Cancer
- Being tested
- No intervention
- Keywords
- Nutrition, Breast Cancer, Cancer Survivors, Quality of Life, Treatment Adherence, Social Determinants
- Medical subject headings
- Breast Neoplasms, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study. There is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Young Breast Cancer Survivors | The investigators will enroll approximately 384 female breast cancer patients. Only non-institutionalized, English literate, female breast cancer patients diagnosed within the previous ten years and younger than 50 years old at the time of diagnosis will be eligible. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on Health-related Quality of Life Measure
For Aim 1, health-related quality of life (HRQoL) is a multidimensional concept that not only includes physical, psychological and social domains, but may also encompass other domains such as cognitive functioning. Cancer patients also exhibit many symptoms (e.g., fatigue, pain, sleep disturbance) that are not measurable directly from laboratory tests. Thus, assessing HRQoL and these symptom burdens among cancer survivors will need to rely on patients' self-reports, measured by validated instruments especially for patients with breast cancer. Participants will complete the 37-item Functional Assessment of Cancer Therapy-B with a 5-point Likert-type scale capturing the domains of Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being, and a Breast Cancer Subscale. Item responses are scored according to scoring guidelines ranging from scores of 0 to 148, with a higher score representing better quality of life.
Measured: Measured at one point in time, from 0-10 years after diagnosis
Number of Participants with Treatment Adherence Compared to those without Treatment Adherence
For Aim 2, the primary outcome is treatment adherence (at patient-level), which will be determined as per National Comprehensive Cancer Network (NCCN) guidelines and eventually categorized as treatment adherent/non-adherent.
Measured: Up to 2 years post-diagnosis of breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start10 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 University of South CarolinaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Steck, University of South Carolina
- Investigators
- Susan Steck, PhD, MPH, RD, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981716
- Sponsor's protocol ID
- YBCSS-2023
- Acronym
- YBCSS
- Status last verified
- Aug 2023
- First submitted
- 12 Mar 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data from the final research dataset may be shared with execution of a Data Use Agreement. The study protocol and statistical analysis plan are available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Quality of Life and Treatment Adherence Among Early-Age-at-Onset Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05981716
- Acronym / sponsor ID
- YBCSS / YBCSS-2023
- Conditions
- Breast Cancer
- Keywords
- Nutrition, Breast Cancer, Cancer Survivors, Quality of Life, Treatment Adherence, Social Determinants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Aug 2023 (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.
Despite significant overall reductions in mortality rates for breast cancer over the past decade, both incidence and mortality rates have steadily climbed in adults diagnosed before age 50. This research project addresses factors associated with quality of life among and treatment response in early-age-at-onset breast cancer patients. The overall objective is collect information from early-onset breast cancer patients using an online questionnaire and examine factors related to cancer survival, (i.e.,better quality of life, better treatment adherence, less adverse treatment responses).
Aim 1: Identify dietary patterns related to health-related quality of life in early-age-at-onset breast cancer patients. The investigators hypothesize that diet quality is related to better health-related quality of life among young breast cancer survivors.
Aim 2. Identify demographic, social determinants, and geographic factors associated with treatment adherence. The investigators hypothesize that social determinants such as poverty-to-income ratio, education, and proximity to cancer treatment facilities are associated with treatment adherence in early-onset breast cancer.
Detailed description
This is an observational epidemiologic study in which the investigators will collect data from approximately 384 participants at one point in time using online questionnaires (REDCaP and the NCI Diet History Questionnaire III). Recruitment will be conducted via breast cancer survivor social media support groups and advocacy groups. Electronic consent will be granted at the beginning of each online questionnaire. Data collection will occur via self-report in the location chosen by the participant using an online questionnaire. The investigators will use established validated questionnaires used by other previously conducted cohorts to enquire about demographics, occupation, cancer screening history, family history of cancer, comorbidities, cancer and other comorbidity treatment including fertility-related, HRQoL, dietary intake using the online NCI Dietary History Questionnaire III which includes dietary supplement use, residential history, hormonal status, physical activity, tobacco product and alcohol use, experiences with racism, social support, and information on health care utilization.
To accomplish Aim 1, the investigators will use the NCI Diet History Questionnaire III, an online 135-item food frequency questionnaire with 26 dietary supplement questions, reflecting the past one month of intake to estimate food and nutrient intakes and overall dietary patterns.Health related quality of life (HRQoL) is a multidimensional concept that not only includes physical, psychological and social domains, but may also encompass other domains such as cognitive functioning. Cancer patients also exhibit many symptoms (e.g., fatigue, pain, sleep disturbance) that are not measurable directly from laboratory tests. Thus, assessing HRQoL and these symptom burdens among cancer survivors will need to rely on patients' self-reports, measured by validated instruments especially for patients with breast cancer, and includes the Functional Assessment of Cancer Therapy (FACT-B).
Descriptive statistics will be presented as mean (standard deviation) and median (inter quartile range) for continuous variables and as frequency (percentage) for categorical variables. Data visualization tools such as histogram, boxplot, scatterplot and line plot will be employed to assess the trends and outliers in the data. Bivariate association between categorical variables will be tested for statistical significance using Chi-square test or exact test. Differences in continuous variables will be tested for statistical significance using Kruskal-Wallis test. HRQoL data typically are not distributed normally with left-skewed distributions and potential ceiling effects requiring consideration of alternative estimators in multivariate models. A number of different alternative models have been proposed over the standard ordinary least squares approach including beta regression, tobit regression, and two-part modeling. The investigators will assess the distribution of the primary HRQoL measures in building analytic models. With healthy dietary pattern as the primary independent variable and measures of HRQoL serving as primary dependent variable, the investigators expect to find that as diet quality increases, HRQoL increases.
For Aim 2, the investigators will ask study participants to complete questionnaires related to racism, fatalism, and demographics and the investigators will geocode residential histories of participants to measure the role of racism, fatalism, income, education, and proximity to treatment facilities in treatment adherence. The investigators will use geographic information systems to geocode participants' residential histories. Participants will be asked the ZIP code of residence at the time of diagnosis, as well as the ZIP code of the treatment facility in which they received care. If the ZIP code of the treatment facility is unknown, the participant can give the city and state, in which a ZIP code of the central point of the city will be found and used for analysis. Using Microsoft Excel, and the list of latitudes and longitudes by ZIP code, provided by the United States Census Bureau (find citation), the distance in miles between the place of residence and place of treatment will be determined. This distance calculation can be used to help evaluate treatment adherence and the distance to treatment. Residential histories will also be used to determine participant rurality. Regarding the many competing definitions and classification schemes for rurality, Hall et al. found dichotomous definitions mask heterogeneity relevant to health research and studies of accessibility. The investigators will instead use the Rural-Urban Commuting Area (RUCA) codes developed by the Office of Rural Health Policy of the Health Resources and Services Administration and the Economic Research Service of the United States Department of Agriculture (USDA). RUCA codes combine information on population density, urbanicity, and daily commuting patterns to classify census tracts into 22 distinct codes, which can then be consolidated into more manageable classifications.
Descriptive statistics will be presented as mean (standard deviation) and median (inter quartile range) for continuous variables and as frequency (percentage) for categorical variables. Data visualization tools such as histogram, boxplot, scatterplot and line plot will be employed to assess the trends and outliers in the data. The investigators will explore the associations between treatment adherence and each measure of social determinants (such as poverty to income ratio, racism, education, and proximity to treatment facility) using mixed effect logistic regression. The model will be sequentially adjusted for the effect of non-modifiable and modifiable confounders such as age, cancer stage, treatment type, and insurance status.
Recruitment of participants is expected to be ongoing for ~12 months.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young Breast Cancer Survivors | – | Other: No interventionThe investigators will enroll approximately 384 female breast cancer patients. Only non-institutionalized, English literate, female breast cancer patients diagnosed within the previous ten years and younger than 50 years old at the time of diagnosis will be eligible. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The investigators plan to enroll 384 women who were previously diagnosed with breast cancer prior to the age of 50 years.
Key inclusion criteria (4 listed)
- Non-institutionalized
- English literate
- Female breast cancer survivors
- Diagnosed with breast cancer within the past 10 years and diagnosed younger than age 50 years
Key exclusion criteria (2 listed)
- Male breast cancer survivors
- Breast cancer survivors diagnosed with breast cancer after the age of 50 years
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 |
|---|---|---|
| No interventionThis is an observational study. There is no intervention. | Other | Young Breast Cancer Survivors |
Primary outcome
Score on Health-related Quality of Life Measure
Time frame: Measured at one point in time, from 0-10 years after diagnosis
For Aim 1, health-related quality of life (HRQoL) is a multidimensional concept that not only includes physical, psychological and social domains, but may also encompass other domains such as cognitive functioning. Cancer patients also exhibit many symptoms (e.g., fatigue, pain, sleep disturbance) that are not measurable directly from laboratory tests. Thus, assessing HRQoL and these symptom burdens among cancer survivors will need to rely on patients' self-reports, measured by validated instruments especially for patients with breast cancer. Participants will complete the 37-item Functional Assessment of Cancer Therapy-B with a 5-point Likert-type scale capturing the domains of Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being, and a Breast Cancer Subscale. Item responses are scored according to scoring guidelines ranging from scores of 0 to 148, with a higher score representing better quality of life.
Number of Participants with Treatment Adherence Compared to those without Treatment Adherence
Time frame: Up to 2 years post-diagnosis of breast cancer
For Aim 2, the primary outcome is treatment adherence (at patient-level), which will be determined as per National Comprehensive Cancer Network (NCCN) guidelines and eventually categorized as treatment adherent/non-adherent.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: Yes. De-identified participant data from the final research dataset may be shared with execution of a Data Use Agreement. The study protocol and statistical analysis plan are available upon reasonable request.
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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.
Susan Steck, PhD, MPH, RD principal investigator
University of South Carolina
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 University of South Carolina 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 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susan Steck, PhD, MPH, RD (8037771527, stecks@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on Health-related Quality of Life Measure (time frame: Measured at one point in time, from 0-10 years after diagnosis). The study lists 2 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 14 Aug 2023.