Breast NeoplasmsNCT04117438
Tell us Your Food Story
An observational study of Breast Neoplasms, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
In 2017, it is estimated that 318,590 Americans, men and women, will be diagnosed with breast cancer (American Cancer Society, 13). It was predicted in the 1970s that 1 in 11 Americans would be diagnosed with breast cancer, currently, it is 1 in 8 people. Read more about this study
- Who is it for?
- Ages Up to 99 years, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 20 Nov 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 Up to 99 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Little is known about a patient and their food stories before, during and after cancer treatment. The investigators would like to understand how cancer impacts a patients food narrative. Patients that live in areas where food is less readily accessible maybe looking for ways to improve their food narrative. This population will only include any 18 or older adult with a history of breast cancer.
Who may be able to join
- Any patient that lives in Southeastern Wisconsin and has a diagnosis of breast cancer, or a history of breast cancer and is over the age of 18.
Who cannot join
- Any subject that is under the age of 18, that does not live in Southeastern Wisconsin and has no diagnosis of breast cancer, or a history of breast cancer will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53222-3100
About this study
Official title: Interviewing Breast Cancer Patients to Understand the Patients Relationship With Food Before and After Cancer Diagnosis.
In 2017, it is estimated that 318,590 Americans, men and women, will be diagnosed with breast cancer (American Cancer Society, 13). It was predicted in the 1970s that 1 in 11 Americans would be diagnosed with breast cancer, currently, it is 1 in 8 people. A person is twice as likely to be diagnosed with breast cancer if they have one first-degree female with a diagnosis, 3-4 times if there is more than one first-degree female relative with a diagnosis. Reasons for this increase in breast cancer diagnoses are that people are living longer, changes in reproductive patterns, increases or decreases in menopausal hormone use, increased numbers of detection through screening including genetic testing, and the rising prevalence of obesity (American Cancer Society). The purpose of this study is to better understand how a diagnosis of breast cancer supports change in diet and their food story.
Qualitative methodology and specifically the long interview is the method the team will use to gain insight into adult patients' perceptions of their food story.
Read the detailed description
- All interviews will occur at a community clinic or convenient community location.
- Clinical faculty will receive an oral and written overview of the project prior to beginning in case they have patients they want to recommend to participate.
- Physician will approach individual patients to participate during a regular medical office visit, patients will be given an introduction and overview of the study, and then will be asked if they would like to participate in the study.
- If the patient wants to participate, Malika Siker, MD will schedule a time for the patient to meet with a member of the study team to conduct the interview.
- The interview will be scheduled at a time convenient for the patient.
- If the patient does not want to participate, no further action is required
- All study subjects will be adults with the ability to understand the study and consent to participate.
- The sample will be a convenience sample based upon interest in participating.
- At the time of the interview, patients will receive a written and oral overview of the research.
- The subject will have ample time to ask questions before completing the survey or beginning the interview. All study subjects will understand and agree to having the interview audiotaped.
- The interview will take place immediately after the subject has agreed to participate.
- Interviews will last between approximately 60 minutes. Subjects can decline to answer any question and can withdraw from the study at any time during the process.
- Our highest estimate is that 50 subjects will be needed to complete the project.
- Interviews will be audiotaped and transcribed verbatim by a transcription service following the conclusion of the interview.
- The transcriptionist will be instructed to remove any names of individuals that may be discussed by the subject.
- Transcriptions will be placed in a password protected computer file.
- PI will review the transcripts to ensure that transcriptions are anonymous.
- When determined, PI will instruct that the recording be erased.
- The team will only begin analysis after ensuring that all transcripts are anonymous.
- The team will analyze the data for thick description and for themes that emerge during the analysis by following procedures developed by Corbin and Strauss.
- Conditions
- Breast Neoplasms
- Being tested
- no intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
There is no intervention. We are just asking breast cancer patients what their food story is.
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer patients relationship with food.
A patient recently diagnosed with breast cancer will be more aware of the relationship they have with diet then those patients that have been in treatment for an extended period of time. The investigators will analyze the data for thick description and for themes that emerge during the analysis by following procedures developed by Corbin and Strauss.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Oct 2019
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Why it stopped: Due to COVID-19 pandemic, we will not be pursuing this study
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.
- More trials run by Medical College of WisconsinThe 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Rymaszewski, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117438
- Sponsor's protocol ID
- PRO00034502
- Status last verified
- Apr 2023
- First submitted
- 2 Oct 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since these are personal stories, the investigators will not be sharing these with others.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interviewing Breast Cancer Patients to Understand the Patients Relationship With Food Before and After Cancer Diagnosis.
- ClinicalTrials.gov ID
- NCT04117438
- Acronym / sponsor ID
- PRO00034502
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to COVID-19 pandemic, we will not be pursuing this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 7 Oct 2019 (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.
In 2017, it is estimated that 318,590 Americans, men and women, will be diagnosed with breast cancer (American Cancer Society, 13). It was predicted in the 1970s that 1 in 11 Americans would be diagnosed with breast cancer, currently, it is 1 in 8 people. A person is twice as likely to be diagnosed with breast cancer if they have one first-degree female with a diagnosis, 3-4 times if there is more than one first-degree female relative with a diagnosis. Reasons for this increase in breast cancer diagnoses are that people are living longer, changes in reproductive patterns, increases or decreases in menopausal hormone use, increased numbers of detection through screening including genetic testing, and the rising prevalence of obesity (American Cancer Society). The purpose of this study is to better understand how a diagnosis of breast cancer supports change in diet and their food story.
Qualitative methodology and specifically the long interview is the method the team will use to gain insight into adult patients' perceptions of their food story.
Detailed description
- All interviews will occur at a community clinic or convenient community location.
- Clinical faculty will receive an oral and written overview of the project prior to beginning in case they have patients they want to recommend to participate.
- Physician will approach individual patients to participate during a regular medical office visit, patients will be given an introduction and overview of the study, and then will be asked if they would like to participate in the study.
- If the patient wants to participate, Malika Siker, MD will schedule a time for the patient to meet with a member of the study team to conduct the interview.
- The interview will be scheduled at a time convenient for the patient.
- If the patient does not want to participate, no further action is required
- All study subjects will be adults with the ability to understand the study and consent to participate.
- The sample will be a convenience sample based upon interest in participating.
- At the time of the interview, patients will receive a written and oral overview of the research.
- The subject will have ample time to ask questions before completing the survey or beginning the interview. All study subjects will understand and agree to having the interview audiotaped.
- The interview will take place immediately after the subject has agreed to participate.
- Interviews will last between approximately 60 minutes. Subjects can decline to answer any question and can withdraw from the study at any time during the process.
- Our highest estimate is that 50 subjects will be needed to complete the project.
- Interviews will be audiotaped and transcribed verbatim by a transcription service following the conclusion of the interview.
- The transcriptionist will be instructed to remove any names of individuals that may be discussed by the subject.
- Transcriptions will be placed in a password protected computer file.
- PI will review the transcripts to ensure that transcriptions are anonymous.
- When determined, PI will instruct that the recording be erased.
- The team will only begin analysis after ensuring that all transcripts are anonymous.
- The team will analyze the data for thick description and for themes that emerge during the analysis by following procedures developed by Corbin and Strauss.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- Up to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Little is known about a patient and their food stories before, during and after cancer treatment. The investigators would like to understand how cancer impacts a patients food narrative. Patients that live in areas where food is less readily accessible maybe looking for ways to improve their food narrative. This population will only include any 18 or older adult with a history of breast cancer.
Key inclusion criteria (1 listed)
- Any patient that lives in Southeastern Wisconsin and has a diagnosis of breast cancer, or a history of breast cancer and is over the age of 18.
Key exclusion criteria (1 listed)
- Any subject that is under the age of 18, that does not live in Southeastern Wisconsin and has no diagnosis of breast cancer, or a history of breast cancer will be excluded.
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 interventionThere is no intervention. We are just asking breast cancer patients what their food story is. | Other | – |
Primary outcome
Breast cancer patients relationship with food.
Time frame: 10 years
A patient recently diagnosed with breast cancer will be more aware of the relationship they have with diet then those patients that have been in treatment for an extended period of time. The investigators will analyze the data for thick description and for themes that emerge during the analysis by following procedures developed by Corbin and Strauss.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Individual participant dataSharing planned: No. Since these are personal stories, the investigators will not be sharing these with others.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Medical College of Wisconsin 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 1 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: withdrawn, as of the sponsor's last update on 7 Apr 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Breast cancer patients relationship with food. (time frame: 10 years). 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 7 Apr 2023.