Lung Cancer Symptom Assessment and Management Intervention

NCT ID: NCT00852462

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SAMI

Intervention Type BEHAVIORAL

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.

Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mary E. Cooley, Phd

Nurse Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary E. Cooley, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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5R01CA125256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-404

Identifier Type: -

Identifier Source: org_study_id

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