Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tell us Your Food Story

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04117438
Recruitment Status : Withdrawn (Due to COVID-19 pandemic, we will not be pursuing this study)
First Posted : October 7, 2019
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Amy Rymaszewski, Medical College of Wisconsin

Brief 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. 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.


Condition or disease Intervention/treatment
Breast Neoplasms Other: no intervention

Detailed Description:
  1. All interviews will occur at a community clinic or convenient community location.
  2. 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.
  3. 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.
  4. 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.
  5. The interview will be scheduled at a time convenient for the patient.
  6. If the patient does not want to participate, no further action is required
  7. All study subjects will be adults with the ability to understand the study and consent to participate.
  8. The sample will be a convenience sample based upon interest in participating.
  9. At the time of the interview, patients will receive a written and oral overview of the research.
  10. 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.

  11. The interview will take place immediately after the subject has agreed to participate.
  12. 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.
  13. Our highest estimate is that 50 subjects will be needed to complete the project.
  14. Interviews will be audiotaped and transcribed verbatim by a transcription service following the conclusion of the interview.
  15. The transcriptionist will be instructed to remove any names of individuals that may be discussed by the subject.
  16. Transcriptions will be placed in a password protected computer file.
  17. PI will review the transcripts to ensure that transcriptions are anonymous.
  18. When determined, PI will instruct that the recording be erased.
  19. The team will only begin analysis after ensuring that all transcripts are anonymous.
  20. 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Interviewing Breast Cancer Patients to Understand the Patients Relationship With Food Before and After Cancer Diagnosis.
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : November 20, 2020
Actual Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Other: no intervention
    There is no intervention. We are just asking breast cancer patients what their food story is.


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04117438


Locations
Layout table for location information
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53222-3100
Sponsors and Collaborators
Medical College of Wisconsin
Layout table for additonal information
Responsible Party: Amy Rymaszewski, Research Associate II, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04117438    
Other Study ID Numbers: PRO00034502
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since these are personal stories, the investigators will not be sharing these with others.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases