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Perception Prognosis, Goals of Treatment, and Communication

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Temel, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01401894
First received: July 20, 2011
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Gastric Cancer
Esophageal Cancer
Pancreatic Cancer
Liver Cancer
Biliary Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Pilot Study to Investigate Advanced Cancer Patient's Perspective of Their Prognosis, Goals of Treatment, and Quality of Communication With Their Oncologists

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Completion of surveys [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients perceptions of prognosis, goals of care, and communication with providers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality of end of life care [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior chemotherapy for current stage of disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401894

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jennifer Temel, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jennifer Temel, MD, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01401894     History of Changes
Other Study ID Numbers: 10-219
Study First Received: July 20, 2011
Last Updated: May 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
advanced cancer

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

ClinicalTrials.gov processed this record on May 19, 2013