Lung CancerPhase 2NCT00852462
Lung Cancer Symptom Assessment and Management Intervention
A Phase 2 study testing SAMI in people with Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- SAMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2008to Jun 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients: Any patient who needs emergent care, routine visits scheduled less than once a month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
About this study
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).
- Conditions
- Lung Cancer
- Being tested
- SAMI
- Keywords
- SAMI, Symptom Assessment and Management Intervention Program
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAMIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SAMI | 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. Receives: Behavioral: SAMI |
| Usual Care | No intervention | Symptom assessment and management follows customary procedures in each study site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
% completion of intervention use and adherence to suggested symptom management strategies.
Measured: 2 years
Secondary outcomes (1)
Health-related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionAug 2012
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mary E. Cooley, Phd, Dana-Farber Cancer Institute
- Investigators
- Mary E. Cooley, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00852462
- Sponsor's protocol ID
- 07-404
- Other IDs
- 5R01CA125256
- Status last verified
- Oct 2016
- First submitted
- 26 Feb 2009
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Symptom Assessment and Management Intervention
- ClinicalTrials.gov ID
- NCT00852462
- Acronym / sponsor ID
- 07-404
- Conditions
- Lung Cancer
- Keywords
- SAMI, Symptom Assessment and Management Intervention Program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Boston Medical Center, National Cancer Institute (NCI)
- Study start
- May 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAMI | Experimental | Behavioral: SAMIPatients 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 | No intervention | –Symptom assessment and management follows customary procedures in each study site. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients: Any patient who needs emergent care, routine visits scheduled less than once a month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAMIPatients 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. | Behavioural | SAMI |
Primary outcome
% completion of intervention use and adherence to suggested symptom management strategies.
Time frame: 2 years
1 secondary outcome
Health-related quality of life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary E. Cooley, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SAMI in people with Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% completion of intervention use and adherence to suggested symptom management strategies. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2016.