Gastric CancerNCT01401894
Perception Prognosis, Goals of Treatment, and Communication
An observational study of Gastric Cancer and Esophageal Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer, Pancreatic Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Jun 2014
- 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: All patients with a recent diagnosis of advanced gastric, esophageal, pancreatic and hepatobiliary cancer, not being treated with curative intent and receiving their cancer care at Massachusetts General Hospital.
Who may be able to join
- Confirmed new diagnosis of advanced gastric, esophageal, pancreatic, and hepatobiliary cancer, not being treated with curative intent.
- Planning to receive chemotherapy at Massachusetts General Hospital
- Ability to read and respond to questions in English.
Who cannot join
- Prior chemotherapy for current stage of disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot Study to Investigate Advanced Cancer Patient's Perspective of Their Prognosis, Goals of Treatment, and Quality of Communication With Their Oncologists
The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. This study will help us to figure out how the investigators can improve how other patients understand their illness and goals of treatment and help us improve communication with their doctors. This research is being done because there is not a lot of information on how much patients understand about their illness and prognosis.
Read the detailed description
- Participants will be asked to answer a few basic questions regarding race, ethnicity, religion, relationship status, education, income, and living situation.
- They will then be asked to complete a questionnaire which contains questions about their mood, spirituality, quality of life and their understanding of their treatment and prognosis and their communication with their oncologist. They will complete these questionnaires in the clinic or infusion room on one of their regularly scheduled visit.
- Keywords
- advanced cancer
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms, Pancreatic Neoplasms, Liver Neoplasms, Biliary Tract Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of surveys
Measured: 1 year
Secondary outcomes (3)
Patients perceptions of prognosis, goals of care, and communication with providers
Measured: 1 year
Quality of end of life care
Measured: 1 year
Survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, El-Jawahri, Areej,M.D., Massachusetts General Hospital
- Investigators
- Jennifer Temel, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401894
- Sponsor's protocol ID
- 10-219
- Status last verified
- Jan 2017
- First submitted
- 20 Jul 2011
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate Advanced Cancer Patient's Perspective of Their Prognosis, Goals of Treatment, and Quality of Communication With Their Oncologists
- ClinicalTrials.gov ID
- NCT01401894
- Acronym / sponsor ID
- 10-219
- Keywords
- advanced cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2011 (estimated)
- 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.
The purpose of this research study is to assess what the participant understands about their illness, prognosis, the goals of the cancer treatment and their communication with their oncology providers. This study will help us to figure out how the investigators can improve how other patients understand their illness and goals of treatment and help us improve communication with their doctors. This research is being done because there is not a lot of information on how much patients understand about their illness and prognosis.
Detailed description
- Participants will be asked to answer a few basic questions regarding race, ethnicity, religion, relationship status, education, income, and living situation.
- They will then be asked to complete a questionnaire which contains questions about their mood, spirituality, quality of life and their understanding of their treatment and prognosis and their communication with their oncologist. They will complete these questionnaires in the clinic or infusion room on one of their regularly scheduled visit.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a recent diagnosis of advanced gastric, esophageal, pancreatic and hepatobiliary cancer, not being treated with curative intent and receiving their cancer care at Massachusetts General Hospital.
Key inclusion criteria (3 listed)
- Confirmed new diagnosis of advanced gastric, esophageal, pancreatic, and hepatobiliary cancer, not being treated with curative intent.
- Planning to receive chemotherapy at Massachusetts General Hospital
- Ability to read and respond to questions in English.
Key exclusion criteria (1 listed)
- Prior chemotherapy for current stage of disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Completion of surveys
Time frame: 1 year
3 secondary outcomes
Patients perceptions of prognosis, goals of care, and communication with providers
Time frame: 1 year
Quality of end of life care
Time frame: 1 year
Survival
Time frame: 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 Jan 2017.
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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.
Jennifer Temel, MD principal investigator
Massachusetts General Hospital
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 Cancer and Esophageal Cancer, run by Massachusetts General Hospital 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 Jan 2017. 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?
Completion of surveys (time frame: 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 Jan 2017.