Gastric AdenocarcinomaNCT04483349
Assessment of What Patients and Healthcare Providers Value
An observational study of Gastric Adenocarcinoma and Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience), and how these patients’ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Pancreatic Neuroendocrine Carcinoma
- What is being tested?
- Survey Administration
- How many people
- 397 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 11 Aug 2022
- 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 pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma, and healthcare providers involved in the care of gastric and pancreatic cancer patients at the MD Anderson Cancer Center
Who may be able to join
- Any patient who has been treated, or is anticipated to be treated, for potentially resectable, biopsy-proven pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma
- Providers involved in the care of gastric and pancreatic cancer patients. Providers will include non-collaborative surgical oncologists, medical oncologists, radiation oncologists, administrators, nurses, mid-level providers
- Able to understand the description of the study and willing to participate
Who cannot join
- Inability to read and answer questions in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "What Do You Value?" A Survey Study Assessing How Patients and Health Care Providers Weigh the Different Components of the Value Equation
To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience), and how these patients’ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).
Read the detailed description
PRIMARY OBJECTIVE:
- To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience).
SECONDARY OBJECTIVES:
- To assess which attributes of value (i.e., outcomes, QOL, cost, experience) health care providers (i.e., physicians, nurses, administrators) feel are most important in health care delivery.
II. To assess how these patients' views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).
III. To assess how patients' view differ to health providers.
OUTLINE:
Patients and healthcare providers complete a survey over 10-15 minutes.
- Being tested
- Survey Administration
- Medical subject headings
- Somatostatinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey administration) | Patients and healthcare providers complete a survey over 10-15 minutes. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
We will calculate the mean rank of patients yielding usable data and its corresponding 95% confidence interval. Patient characteristics and survey items will be summarized using descriptive statistics, including means, standard deviations (SDs), proportions, range, and 95% confidence intervals (CIs), etc.
Measured: Survey completion up to 1 year
Secondary outcomes (2)
Most important attributes of value to healthcare providers
Provider characteristics and survey items will be summarized using descriptive statistics, including means, SDs, proportions, range, and 95% CIs, etc.
Measured: Survey completion up to 1 year
Importance care providers (i.e., physicians, nurses, administrators) place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
Chi-square tests (or Fisher's exact test) will be used to compare the results between patients and providers.
Measured: Survey completion 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 posted23 Jul 2020
- Study start11 Jun 2020
- Primary completion11 Aug 2022
- Study completion11 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Matthew H Katz, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483349
- Sponsor's protocol ID
- 2020-0211
- Other IDs
- NCI-2020-04577, 2020-0211, P30CA016672
- Status last verified
- Aug 2022
- First submitted
- 14 Jul 2020
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "What Do You Value?" A Survey Study Assessing How Patients and Health Care Providers Weigh the Different Components of the Value Equation
- ClinicalTrials.gov ID
- NCT04483349
- Acronym / sponsor ID
- 2020-0211
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 11 Aug 2022 (actual)
- First posted
- 23 Jul 2020 (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.
To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience), and how these patients’ views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).
Detailed description
PRIMARY OBJECTIVE:
- To assess the importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience).
SECONDARY OBJECTIVES:
- To assess which attributes of value (i.e., outcomes, QOL, cost, experience) health care providers (i.e., physicians, nurses, administrators) feel are most important in health care delivery.
II. To assess how these patients' views differ depending on the stage of their therapy (pretreatment, preoperative therapy, post-operative, long-term surveillance, recurrence).
III. To assess how patients' view differ to health providers.
OUTLINE:
Patients and healthcare providers complete a survey over 10-15 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey administration) | – | Other: Survey AdministrationPatients and healthcare providers complete a survey over 10-15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma, and healthcare providers involved in the care of gastric and pancreatic cancer patients at the MD Anderson Cancer Center
Key inclusion criteria (3 listed)
- Any patient who has been treated, or is anticipated to be treated, for potentially resectable, biopsy-proven pancreatic adenocarcinoma, pancreatic neuroendocrine malignancy, or gastric adenocarcinoma
- Providers involved in the care of gastric and pancreatic cancer patients. Providers will include non-collaborative surgical oncologists, medical oncologists, radiation oncologists, administrators, nurses, mid-level providers
- Able to understand the description of the study and willing to participate
Key exclusion criteria (1 listed)
- Inability to read and answer questions in English
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 |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey administration) |
Primary outcome
Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
Time frame: Survey completion up to 1 year
We will calculate the mean rank of patients yielding usable data and its corresponding 95% confidence interval. Patient characteristics and survey items will be summarized using descriptive statistics, including means, standard deviations (SDs), proportions, range, and 95% confidence intervals (CIs), etc.
2 secondary outcomes
Most important attributes of value to healthcare providers
Time frame: Survey completion up to 1 year
Importance care providers (i.e., physicians, nurses, administrators) place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience)
Time frame: Survey completion up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Related InfoLink provided by the sponsor.
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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.
Matthew H Katz principal investigator
M.D. Anderson Cancer Center
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 Gastric Adenocarcinoma and Pancreatic Adenocarcinoma, run by M.D. Anderson Cancer Center 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 31 Aug 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Importance patients place on each of the attributes of value (i.e., outcomes, quality of life [QOL], cost, experience) (time frame: Survey completion 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 31 Aug 2022.