Lung Cancer Symptom Assessment and Management Intervention

Dana-Farber Cancer Institute

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Behavioral: SAMI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00852462

07-404

5R01CA125256 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 179 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 2 patient groups

SAMI

Experimental group

Description:

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.

Treatment:

Behavioral: SAMI

Usual Care

No Intervention group

Description:

Symptom assessment and management follows customary procedures in each study site.