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

Withdrawn

• Conditions: Pancreatic Carcinoma; Cholangiocarcinoma; Colorectal Carcinoma; Breast Carcinoma; Gastric Carcinoma; Malignant Digestive System Neoplasm; Prostate Carcinoma
• Interventions: Other: Interview; Other: Survey Administration

• Registration Number: NCT03563352
• Lead Sponsor: University of Southern California

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-20
• Study Start: 2018-08-30
• Primary Completion: 2020-09-24
• Study Completion: 2020-09-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-10
• Last Update Posted: 2020-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (interview, survey)	Interview	Participants attend an interview over 15 minutes and complete surveys.
Observational (interview, survey)	Survey Administration	Participants attend an interview over 15 minutes and complete surveys.

Primary Outcome Measures

Name	Time	Method
The way patients with cancer choose and obtain nutritional supplements to support medical management	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

Name	Time	Method
Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies	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.

Trial Locations

Locations (1)

USC / Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States