Cancer Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | March 2009 |
Est. primary completion date | March 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia- School of Nursing | Charlottesville | Virginia |
United States | Memorial Sloan-Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Institute of Nursing Research (NINR), University of Virginia |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | No | |
Secondary | 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. | 2 years | No |
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