NCT02055313

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

8.4 years

First QC Date

January 30, 2014

Last Update Submit

February 23, 2021

Conditions

Keywords

Exceptional patientCancer careLung cancerPancreatic cancerStomach cancerUnexplained survivalstill alive from 2001-2008

Outcome Measures

Primary Outcomes (1)

  • 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.

    Two years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic NeoplasmsLung NeoplasmsStomach NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Moshe A Frenkel, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Moshe Frenkel MD

Study Record Dates

First Submitted

January 30, 2014

First Posted

February 5, 2014

Study Start

May 1, 2012

Primary Completion

October 1, 2020

Study Completion

December 1, 2020

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share