Lung Cancer Symptom Assessment and Management Intervention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Boston Medical Center
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00852462
First received: February 26, 2009
Last updated: October 22, 2013
Last verified: October 2013
  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:


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 2014
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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: October 22, 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 September 16, 2014