Overview

This trial is active, not recruiting.

Condition lung cancer
Treatment sami
Phase phase 2
Sponsor Dana-Farber Cancer Institute
Collaborator Boston Medical Center
Start date May 2008
End date August 2012
Trial size 179 participants
Trial identifier NCT00852462, 07-404, 5R01CA125256

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
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)
Symptom assessment and management follows customary procedures in each study site.

Primary Outcomes

Measure
% completion of intervention use and adherence to suggested symptom management strategies.
time frame: 2 years

Secondary Outcomes

Measure
Health-related quality of life
time frame: 6 months

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Lung Cancer Symptom Assessment and Management Intervention
Principal investigator Mary E. Cooley, PhD
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.