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Lung Cancer Symptom Assessment and Management Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852462
First Posted: February 27, 2009
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Boston Medical Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute
February 26, 2009
February 27, 2009
October 21, 2016
May 2008
August 2012   (Final data collection date for primary outcome measure)
% completion of intervention use and adherence to suggested symptom management strategies. [ Time Frame: 2 years ]
To determine the usability of a computerized symptom assessment tool for patients and the usability of the output tool in the form of patient-specific data and care recommendations for HCPs. [ Time Frame: 2 years ]
Complete list of historical versions of study NCT00852462 on ClinicalTrials.gov Archive Site
Health-related quality of life [ Time Frame: 6 months ]
Not Provided
Not Provided
Not Provided
 
Lung Cancer Symptom Assessment and Management Intervention
Lung Cancer Symptom Assessment and Management Intervention
The purpose of this study is to develop and test the usability of a computerized symptom assessment and management intervention system in a laboratory setting (phase I) and its feasibility in a clinical setting in a group randomized trial (phase II).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Lung Cancer
Behavioral: SAMI
Patients and Health care providers use Symptom Assessment and Management Intervention: patient report symptoms by answering validated questionnaires in a secure online program. The system generates a report for providers that displays symptoms and customized suggestions for their clinical management.
  • Experimental: SAMI
    Patients and Health care providers use Symptom Assessment and Management Intervention: patient report symptoms by answering validated questionnaires in a secure online program. The system generates a report for providers that displays symptoms and customized suggestions for their clinical management.
    Intervention: Behavioral: SAMI
  • No Intervention: Usual Care
    Symptom assessment and management follows customary procedures in each study site.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
June 2016
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • HCPs: attending physician, thoracic medical oncologist, expected to work in the setting for at least 2 years.
  • Patients: 21 years of age or older; diagnosis of Stage IIIA, IIIB, IV non-small cell lung cancer OR limited or extensive stage small cell lung cancer; receiving care in the out-patient setting; receiving treatment with chemotherapy +/- additional therapies; English speaking.

Exclusion Criteria:

  • Patients: Any patient who needs emergent care, routine visits scheduled less than once a month
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00852462
07-404
5R01CA125256 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Mary E. Cooley, Phd, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Boston Medical Center
  • National Cancer Institute (NCI)
Principal Investigator: Mary E. Cooley, PhD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP