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Lung Cancer Symptom Assessment and Management Intervention

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ClinicalTrials.gov Identifier: NCT00852462
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : October 21, 2016
Sponsor:
Collaborators:
Boston Medical Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Lung Cancer Behavioral: SAMI Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Lung Cancer Symptom Assessment and Management Intervention
Study Start Date : May 2008
Primary Completion Date : August 2012
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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.
No Intervention: Usual Care
Symptom assessment and management follows customary procedures in each study site.



Primary Outcome Measures :
  1. % completion of intervention use and adherence to suggested symptom management strategies. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852462


Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Dana-Farber Cancer Institute
Boston Medical Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Mary E. Cooley, PhD Dana-Farber Cancer Institute

Responsible Party: Mary E. Cooley, Phd, Nurse Scientist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00852462     History of Changes
Other Study ID Numbers: 07-404
5R01CA125256 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Mary E. Cooley, Phd, Dana-Farber Cancer Institute:
SAMI
Symptom Assessment and Management Intervention Program

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases