NCT03563352

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.

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 Aug 2018

Typical duration for all trials

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withdrawn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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 30, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2020

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

2.1 years

First QC Date

June 8, 2018

Last Update Submit

December 10, 2020

Conditions

Breast CarcinomaCholangiocarcinomaColorectal CarcinomaGastric CarcinomaMalignant Digestive System NeoplasmPancreatic CarcinomaProstate Carcinoma

Outcome Measures

Primary Outcomes (1)

  • The way patients with cancer choose and obtain nutritional supplements to support medical management

    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 Outcomes (1)

  • Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies

    Up to 1 year

Study Arms (1)

Observational (interview, survey)

Participants attend an interview over 15 minutes and complete surveys.

Other: InterviewOther: Survey Administration

Interventions

InterviewOTHER

Attend an interview

Observational (interview, survey)
Survey AdministrationOTHER

Ancillary studies

Observational (interview, survey)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCholangiocarcinomaColorectal NeoplasmsStomach NeoplasmsGastrointestinal NeoplasmsPancreatic NeoplasmsProstatic Neoplasms

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeIntestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesStomach DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jacek Pinski, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 20, 2018

Study Start

August 30, 2018

Primary Completion

September 24, 2020

Study Completion

September 24, 2020

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

US(1)