- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00579215
Lung Cancer Informational Study (LCIS)
The purpose of this study is to evaluate a new program to help the patient and the caregiver make decisions about treatment for lung cancer. We need to know if a new information program is helpful to patients. The way that we will do this is by comparing it with the usual information program that we now provide.
Patient are asked to make difficult decisions about their treatments. These decisions may include when to change treatments or when to stop treatment altogether. Most patients ask a family member or close friend to help them with these difficult decisions. A "caregiver" is someone they can count on to give support (either emotional or physical) over a period of time. The doctors and nurses will also help patients and their caregiver to make these decisions.
They will tell them the risks with each treatment, the success with each treatment, and how much time there is for making each decision.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan-Kettering Cancer Center
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- University of Virginia- School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pathologically or cytologically determined non-small cell lung cancer
- Stage IIIA, IIIB or IV extent
- No prior chemotherapy unless used in adjuvant therapy, completed more than two years ago, and no sign of any other malignancy active at this time
- Lung cancer-directed treatment with a standard or investigative chemotherapy regimen at entry
- Patients with brain metastasis are acceptable provided they are at least 3 weeks from completion of radiation therapy for brain metastasis, have stable and acceptable neurological status, and meet all other eligibility criteria. For patients undergoing gamma knife procedure, cognitive ability is the judgment call of the oncologist and study nurse as to whether comprehension is not a problem.
Exclusion Criteria:
- Performance status of KPS 60-100% or ECOG 0-2;
- No age limit
- Life expectancy greater than three months
- A caregiver (any family member or concerned other who consistently provides emotional and/or physical support) available to also participate
- Patient and caregiver are able to understand English (ability to repeat back in their own words)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Enhance Care (EC) will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment.
Self-report measures will be used for all participants in addition to probes for the taped interviews with EC.
The outcome measures are quality decision making and decisional conflict.
Two panels (decision making and lung cancer) will review the protocol twice.
The plan will include serially screening the appointment roster.
The decision aid will be administered during three clinic visits.
|
EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment.
Self-report measures will be used for all participants in addition to probes for the taped interviews with EC.
The outcome measures are quality decision making and decisional conflict.
Two panels (decision making and lung cancer) will review the protocol twice.
The plan will include serially screening the appointment roster.
The decision aid will be administered during three clinic visits
Other Names:
|
Other: 2
As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making.
Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.
|
As an intentional control, the usual care group will receive standard care related to lung cancer and treatment; they will not receive any oral, written, or recorded information related to decision making.
Usual care includes anticipatory guidance related to the disease and treatment (e.g., what to do about treatment side effects, signs of an infection, why a treatment would be changed or stopped) using patient education materials normally used in the MSKCC, TOS, Outpatient Clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment.
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To gather data for testing the hypothesis that patients with advanced lung cancer who receive a decision aid will report increased quality decision making, and decreased decisional conflict at the end of Decision 3 compared to the usual care group.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Leslie B Tyson, NO, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-141
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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