Breast CarcinomaNCT03563352
Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer
An observational study of Breast Carcinoma and Cholangiocarcinoma, run by University of Southern California at 1 site in United States.
Trial summary
This trial studies nutritional preferences and product accessibility in oral nutritional supplements in participants with breast, colorectal, upper gastrointestinal, or prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma
- What is being tested?
- Interview and Survey Administration
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2018to 24 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- Identify how patients with cancer are obtaining nutrition to support medical management.
SECONDARY OBJECTIVES:
- 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.
- Conditions
- Breast Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma, Gastric Carcinoma, Malignant Digestive System Neoplasm, Pancreatic Carcinoma
- Being tested
- Interview, Survey Administration
- Medical subject headings
- Breast Neoplasms, Cholangiocarcinoma, Colorectal Neoplasms, Stomach Neoplasms, Gastrointestinal Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Attend an interview
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (interview, survey) | Participants attend an interview over 15 minutes and complete surveys. Receives: Other: Interview; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (1)
Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies
Data from the survey will be used for testing the association of gastrointestinal side effects with specific diagnosis and medical therapies.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start30 Aug 2018
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
Why it stopped: Zero accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jacek Pinski, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563352
- Sponsor's protocol ID
- 0S-17-4
- Other IDs
- NCI-2018-00948, 0S-17-4, P30CA014089
- Status last verified
- Dec 2020
- First submitted
- 8 Jun 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03563352
- Acronym / sponsor ID
- 0S-17-4
- Conditions
- Breast Carcinoma, Cholangiocarcinoma, Colorectal Carcinoma, Gastric Carcinoma, Malignant Digestive System Neoplasm, Pancreatic Carcinoma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Zero accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 20 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Identify how patients with cancer are obtaining nutrition to support medical management.
SECONDARY OBJECTIVES:
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview, survey) | – | Other: Interview, Other: Survey AdministrationParticipants attend an interview over 15 minutes and complete surveys. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAttend an interview | Other | Observational (interview, survey) |
| Survey AdministrationAncillary studies | Other | Observational (interview, survey) |
Primary outcome
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.
1 secondary outcome
Associations of gastrointestinal side effects with specific diagnoses and respective medical therapies
Time frame: Up to 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacek Pinski, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma and Cholangiocarcinoma, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The way patients with cancer choose and obtain nutritional supplements to support medical management (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.