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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
  Purpose

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 Intervention Phase
Lung Cancer
 Behavioral: SAMI
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Lung Cancer Symptom Assessment and Management Intervention

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • % completion of intervention use and adherence to suggested symptom management strategies. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: May 2008
Estimated Study Completion Date: June 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: February 26, 2009
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013