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Trial record 24 of 208 for:    Oral Cancer | Recruiting Studies | NIH

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 : Recruiting
First Posted : June 20, 2018
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

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 Type : Observational
Estimated Enrollment : 180 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
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

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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

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


Contacts
Contact: Cheryl Kefauver, RN 323-865-0459 Cheryl.Kefauver@med.usc.edu

Locations
United States, California
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Cheryl Kefauver, RN    323-865-0459    Cheryl.Kefauver@med.usc.edu   
Principal Investigator: Jacek Pinski, MD         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jacek Pinski, MD University of Southern California

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT03563352     History of Changes
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: September 3, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Prostatic Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Intestinal Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Endocrine Gland Neoplasms
Carcinoma
Cholangiocarcinoma
Breast Diseases
Skin Diseases
Adenocarcinoma
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Genital Diseases, Male
Prostatic Diseases
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases