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Lung Cancer Symptom Assessment and Management Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boston Medical Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00852462
First received: February 26, 2009
Last updated: April 23, 2013
Last verified: April 2013
History of Changes

February 26, 2009
April 23, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852462 on ClinicalTrials.gov Archive Site
Health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Active, not recruiting
180
June 2013
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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852462
07-404, 5R01CA125256
Yes
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
April 2013

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