Back to resultsLung Cancer Symptom Assessment and Management Intervention
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SAMI
Sponsored by
About this trial
This is an interventional supportive care trial for Lung Cancer focused on measuring SAMI, Symptom Assessment and Management Intervention Program
Eligibility Criteria
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
Sites / Locations
- Dana-Farber Cancer Institute
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
SAMI
Usual Care
Arm 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.
Symptom assessment and management follows customary procedures in each study site.
Outcomes
Primary Outcome Measures
% completion of intervention use and adherence to suggested symptom management strategies.
Secondary Outcome Measures
Health-related quality of life
Full Information
NCT ID
NCT00852462
First Posted
February 26, 2009
Last Updated
October 19, 2016
Sponsor
Dana-Farber Cancer Institute
Collaborators
Boston Medical Center, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00852462
Brief Title
Lung Cancer Symptom Assessment and Management Intervention
Official Title
Lung Cancer Symptom Assessment and Management Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Boston Medical Center, National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
SAMI, Symptom Assessment and Management Intervention Program
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
179 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SAMI
Arm Type
Experimental
Arm 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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Symptom assessment and management follows customary procedures in each study site.
Intervention Type
Behavioral
Intervention Name(s)
SAMI
Intervention 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.
Primary Outcome Measure Information:
Title
% completion of intervention use and adherence to suggested symptom management strategies.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Health-related quality of life
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary E. Cooley, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Lung Cancer Symptom Assessment and Management Intervention
We'll reach out to this number within 24 hrs