Pancreatic CancerNCT02055313
Perceptions of Exceptional Patients in Cancer Care Relating to Their Unusual Survival
An observational study of Pancreatic Cancer and Lung Cancer, run by Meir Medical Center.
Trial summary
The main objective of this study is to explore experiences and insights from exceptional patients, patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Lung Cancer, Stomach Cancer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Dec 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 will be identified through the HMO registry in a region of 630,000 members with a diagnosis of pancreatic cancer, advanced lung cancer, advanced stomach cancer and advanced esophageal cancer that are still alive from 2001-2008.
Who may be able to join
- 18 years of age or older Ability to speak and read Hebrew, English or Russian. Diagnosis of pancreatic adenocarcinoma advanced lung cancer, advanced stomach cancer and advanced esophageal cancer confirmed by the treating physician, laboratory tests and medical imaging techniques.
- Pancreatic adenocarcinoma patient advanced lung cancer, advanced stomach cancer and advanced esophageal cancer patient who is alive when his probability of doing so was less than 15%.
- Consent to participate in this study
- -
Who cannot join
- Inability to understand the intent of the study Medical condition that would preclude participation in an interview session lasting over 30 minutes Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
About this study
Official title: The Exceptional Patient in Cancer Care
The main objective of this study is to explore experiences and insights from exceptional patients, patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
A secondary future objective of this study is to develop an international multicenter registry and database documenting and examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
Read the detailed description
This pilot study will utilize a population registry in one location (Israel) to identify exceptional patients with one terminal disease. Pancreatic malignancy, advanced lung cancer; advanced stomach cancer and advanced esophageal cancer have been chosen as the specific terminal disease, based on its extremely high mortality rate. These specific situations can apply to a strict definition set by Gotay: "An exceptional survivor is a cancer patient who is alive when the probability of doing so was less than 25% of living for five or more years , for a given type and stage." [48] These types of cancers are associated with a 5 year survival of less than 15% and even with the latest technology and advances in cancer care; there is a very slight improvement in survival of these patients.
The study will be divided into three stages:
- Identifying the patients Clalit HMO will be approached to obtain ethical committee's approval to the study and access to the HMO registry. Clalit HMO is the largest HMO in Israel with over 4 million members (out of a total population of 7.5 million). After securing this approval, patients will be identified through the HMO registry. We will try to identify patients with a diagnosis of pancreatic cancer advanced lung cancer, advanced stomach cancer and advanced esophageal cancer that are still alive from 2001-2008. Each patient's physician will be contacted to verify that the diagnosis is correct. The physician will be asked to contact the patient and obtain his or her consent to participate in the study. Consenting patients will be sent a letter signed by their primary physician that describes the study and indicates that someone will be calling them to invite them to participate in the study. The letter will clarify that participation is completely voluntary and declining to participate will not affect them in any way.
- Approaching the patients Patients consenting to participate in the study will be contacted by our qualitative researcher (SG) which will interview them following a qualitative study protocol
- Analysis of findings and preparation of summary report.
- Conditions
- Pancreatic Cancer, Lung Cancer, Stomach Cancer, Esophageal Cancer
- Keywords
- Exceptional patient, Cancer care, Lung cancer, Pancreatic cancer, Stomach cancer, Unexplained survival, still alive from 2001-2008
- Medical subject headings
- Pancreatic Neoplasms, Lung Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
Understanding the patient's experience of a disease process is important in assessing and treating a complicated illness. Qualitative research allows participants to describe an experience in the way that is most meaningful to them. A qualitative approach is deemed as the most appropriate to capture the perceptions and experiences of exceptional patients. This study is using an exploratory, qualitative approach consisting of in-depth, semi-structured interviews. This approach has been widely used in health care to better understand the patient experience. Descriptive analysis of sociodemographic, disease-related, and treatment-related factors were conducted to characterize the sample and to verify that sampling criteria were met. The study endpoint is aimed at reaching saturation of recurring themes that were extracted in the interviews.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startMay 2012
- Primary completionOct 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services
- Responsible party
- Principal investigator, Moshe Frenkel, Meir Medical Center
- Investigators
- Moshe A Frenkel, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055313
- Sponsor's protocol ID
- 2012-1
- Status last verified
- Feb 2021
- First submitted
- 30 Jan 2014
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Exceptional Patient in Cancer Care
- ClinicalTrials.gov ID
- NCT02055313
- Acronym / sponsor ID
- 2012-1
- Conditions
- Pancreatic Cancer, Lung Cancer, Stomach Cancer, Esophageal Cancer
- Keywords
- Exceptional patient, Cancer care, Lung cancer, Pancreatic cancer, Stomach cancer, Unexplained survival, still alive from 2001-2008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services
- Study start
- May 2012
- Primary completion
- Oct 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 5 Feb 2014 (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 main objective of this study is to explore experiences and insights from exceptional patients, patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
A secondary future objective of this study is to develop an international multicenter registry and database documenting and examining the experience of patients with cancer that were considered by their physicians as having exceptional course of survival related to their specific disease state.
Detailed description
This pilot study will utilize a population registry in one location (Israel) to identify exceptional patients with one terminal disease. Pancreatic malignancy, advanced lung cancer; advanced stomach cancer and advanced esophageal cancer have been chosen as the specific terminal disease, based on its extremely high mortality rate. These specific situations can apply to a strict definition set by Gotay: "An exceptional survivor is a cancer patient who is alive when the probability of doing so was less than 25% of living for five or more years , for a given type and stage." [48] These types of cancers are associated with a 5 year survival of less than 15% and even with the latest technology and advances in cancer care; there is a very slight improvement in survival of these patients.
The study will be divided into three stages:
- Identifying the patients Clalit HMO will be approached to obtain ethical committee's approval to the study and access to the HMO registry. Clalit HMO is the largest HMO in Israel with over 4 million members (out of a total population of 7.5 million). After securing this approval, patients will be identified through the HMO registry. We will try to identify patients with a diagnosis of pancreatic cancer advanced lung cancer, advanced stomach cancer and advanced esophageal cancer that are still alive from 2001-2008. Each patient's physician will be contacted to verify that the diagnosis is correct. The physician will be asked to contact the patient and obtain his or her consent to participate in the study. Consenting patients will be sent a letter signed by their primary physician that describes the study and indicates that someone will be calling them to invite them to participate in the study. The letter will clarify that participation is completely voluntary and declining to participate will not affect them in any way.
- Approaching the patients Patients consenting to participate in the study will be contacted by our qualitative researcher (SG) which will interview them following a qualitative study protocol
- Analysis of findings and preparation of summary report.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be identified through the HMO registry in a region of 630,000 members with a diagnosis of pancreatic cancer, advanced lung cancer, advanced stomach cancer and advanced esophageal cancer that are still alive from 2001-2008.
Key inclusion criteria (4 listed)
- 18 years of age or older Ability to speak and read Hebrew, English or Russian. Diagnosis of pancreatic adenocarcinoma advanced lung cancer, advanced stomach cancer and advanced esophageal cancer confirmed by the treating physician, laboratory tests and medical imaging techniques.
- Pancreatic adenocarcinoma patient advanced lung cancer, advanced stomach cancer and advanced esophageal cancer patient who is alive when his probability of doing so was less than 15%.
- Consent to participate in this study
- -
Key exclusion criteria (1 listed)
- Inability to understand the intent of the study Medical condition that would preclude participation in an interview session lasting over 30 minutes Diagnosis of active psychosis or severe cognitive impairment confirmed by the patient's attending physician.
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
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
Time frame: Two years
Understanding the patient's experience of a disease process is important in assessing and treating a complicated illness. Qualitative research allows participants to describe an experience in the way that is most meaningful to them. A qualitative approach is deemed as the most appropriate to capture the perceptions and experiences of exceptional patients. This study is using an exploratory, qualitative approach consisting of in-depth, semi-structured interviews. This approach has been widely used in health care to better understand the patient experience. Descriptive analysis of sociodemographic, disease-related, and treatment-related factors were conducted to characterize the sample and to verify that sampling criteria were met. The study endpoint is aimed at reaching saturation of recurring themes that were extracted in the interviews.
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 25 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Moshe A Frenkel, MD principal investigator
Clalit Health Services
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Lung Cancer, run by Meir Medical Center.
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 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 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Qualitative Data Collection: Patients' Experience of Exceptional Disease Course (time frame: Two years). 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 25 Feb 2021.