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Perceptions of Exceptional Patients in Cancer Care Relating to Their Unusual Survival

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Clalit Health Services
Information provided by (Responsible Party):
Moshe Frenkel, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT02055313
First received: January 30, 2014
Last updated: March 21, 2017
Last verified: March 2017
  Purpose

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.


Condition
Pancreatic Cancer Lung Cancer Stomach Cancer Esophageal Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: The Exceptional Patient in Cancer Care

Resource links provided by NLM:


Further study details as provided by Moshe Frenkel, Meir Medical Center:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055313

Sponsors and Collaborators
Meir Medical Center
Clalit Health Services
Investigators
Principal Investigator: Moshe A Frenkel, MD Clalit Health Services
  More Information

Responsible Party: Moshe Frenkel, Moshe Frenkel MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT02055313     History of Changes
Other Study ID Numbers: 2012-1
Study First Received: January 30, 2014
Last Updated: March 21, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Moshe Frenkel, Meir Medical Center:
Exceptional patient
Cancer care
Lung cancer
Pancreatic cancer
Stomach cancer
Unexplained survival
still alive from 2001-2008

Additional relevant MeSH terms:
Pancreatic Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 21, 2017