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Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03563352
Recruitment Status : Withdrawn (Zero accrual)
First Posted : June 20, 2018
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California

Study Description
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Brief Summary:
This trial studies nutritional preferences and product accessibility in oral nutritional supplements in participants with breast, colorectal, upper gastrointestinal, or prostate cancer. Learning what participants like and dislike about their current or past used nutritional supplements may help doctor know how to improve them.

Condition or disease Intervention/treatment
Breast Carcinoma Cholangiocarcinoma Colorectal Carcinoma Gastric Carcinoma Malignant Digestive System Neoplasm Pancreatic Carcinoma Prostate Carcinoma Other: Interview Other: Survey Administration

Detailed Description:

PRIMARY OBJECTIVES:

I. Identify how patients with cancer are obtaining nutrition to support medical management.

SECONDARY OBJECTIVES:

I. Examine associations of gastrointestinal side effects with specific diagnoses and respective medical therapies.

II. Understand how patients access information regarding nutritional supplements.

III. Evaluate patient satisfaction with currently available oral nutritional supplements (ONS).

IV. Identify patient preferences in formulating a novel nutritional supplement.

OUTLINE:

Participants attend an interview over 15 minutes and complete surveys.

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluating Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements for Oncologic Patients - A Cross-Sectional Survey Study at Norris Comprehensive Cancer Center
Actual Study Start Date : August 30, 2018
Actual Primary Completion Date : September 24, 2020
Actual Study Completion Date : September 24, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Observational (interview, survey)
Participants attend an interview over 15 minutes and complete surveys.
 Other: Interview
Attend an interview

Other: Survey Administration
Ancillary studies


Outcome Measures
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Primary Outcome Measures :
  1. The way patients with cancer choose and obtain nutritional supplements to support medical management [ Time Frame: Up to 1 year ]
    Data from the oral nutritional supplement survey that examines quality, quantity, access and affordability of oral nutrional supplements will be summarized.


Secondary Outcome Measures :
  1. Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies [ Time Frame: Up to 1 year ]
    Data from the survey will be used for testing the association of gastrointestinal side effects with specific diagnosis and medical therapies.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the diagnosis of breast cancer, colorectal cancer, upper gastrointestinal cancer (including gastric, pancreatic, and cholangiocarcinoma), and prostate cancer who are seen at the USC facilities will be screened and recruited for this study.
Criteria

Inclusion Criteria:

  • Ability to comprehend English (both reading and writing)
  • Subjects in the inpatient and outpatient setting with the diagnosis of breast cancer, colorectal cancer, upper gastrointestinal cancer (including gastric, pancreatic, and cholangiocarcinoma), or prostate cancer
  • Receiving chemotherapy, biologic, or hormonal therapy in the University of Southern California (USC) Norris Comprehensive Cancer Center Day Hospital
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients with a mental disability that makes them unable to understand and respond to the questions
  • Patients with reported non-oncologic associated deficits in taste and smell
Contacts and Locations
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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): NCT03563352


Locations
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United States, California
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jacek Pinski, MD University of Southern California
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03563352    
Other Study ID Numbers: 0S-17-4
NCI-2018-00948 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
0S-17-4 ( Other Identifier: USC / Norris Comprehensive Cancer Center )
P30CA014089 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Cholangiocarcinoma
Breast Neoplasms
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms by Site
 Breast Diseases
Skin Diseases
Intestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases