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OpenTrials
Completed

NCT Number: NCT00852462

Lung Cancer Symptom Assessment and Management Intervention

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).

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SAMI

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.

Primary outcomes

  1. % completion of intervention use and adherence to suggested symptom management strategies.

    Time frame: 2 years

Secondary outcomes

  1. Health-related quality of life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Boston Medical Center
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2016
First posted
Feb 27, 2009
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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