Clinical trial NCT02055313: Perceptions of Exceptional Patients in Cancer Care Relating to Their Unusual Survival
Official title: The Exceptional Patient in Cancer Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
Collaborators: name: Clalit Health Services
First posted: 2014-02-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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:

1. 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.
2. 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
3. Analysis of findings and preparation of summary report.

Eligibility criteria: Inclusion Criteria:

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

-

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Qualitative Data Collection: Patients' Experience of Exceptional Disease Course
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clalit Health Services
name: Moshe A Frenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: