Lung Cancer Symptom Assessment and Management Intervention

Lung Cancer Clinical Trial

Official title:

Lung Cancer Symptom Assessment and Management Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852462
• Other study ID #: 07-404
• Secondary ID: 5R01CA125256
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2009
• Last updated: October 19, 2016
• Start date: May 2008
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: June 2016
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Boston Medical Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% completion of intervention use and adherence to suggested symptom management strategies.		2 years	No
Secondary	Health-related quality of life		6 months	No