NCT04117438

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

October 2, 2019

Last Update Submit

April 5, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    10 years

Interventions

There is no intervention. We are just asking breast cancer patients what their food story is.

Eligibility Criteria

AgeUp to 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53222-3100, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases
0

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate II

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 7, 2019

Study Start

October 1, 2019

Primary Completion

November 20, 2020

Study Completion

November 20, 2020

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Since these are personal stories, the investigators will not be sharing these with others.

Locations