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

December 10, 2020 updated by: University of Southern California

Evaluating Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements for Oncologic Patients - A Cross-Sectional Survey Study at Norris Comprehensive Cancer Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (interview, survey)
Participants attend an interview over 15 minutes and complete surveys.
Other: Survey Administration
Ancillary studies
Other: Interview
Attend an interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2018

Primary Completion (Actual)

September 24, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

June 8, 2018

First Submitted That Met QC Criteria

June 8, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0S-17-4 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2018-00948 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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