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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 20, 2007 | ||||
| Last Updated Date | March 17, 2009 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00579215 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Lung Cancer Informational Study (LCIS) | ||||
| Official Title ICMJE | Lung Cancer Informational Study (LCIS) | ||||
| Brief Summary | 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. |
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| Detailed Description | Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say "enough." Patient preparation for facing termination of cancer-directed therapy for the number one cause of cancer mortality for both men and women in the U.S. is not well handled in most clinical practices. Sparse literature validates that this concern is often denied by investigators. Failure to engage in a systematic, informed decision-making process, even in the initial stage of treatment, may often result in patients looking back and saying, "Knowing what I know now, I wouldn't make the same choice" The long-term goal of this program of research is to enhance patient care for lung cancer by oncology health professionals and to promote patient empowerment to make informed choices, defined as the ability to actively understand and influence one's health status. For this study, shared decision making is defined as a tailored, interactive process (emphasizing beliefs/personal values) in which the patient is informed enough to ask pertinent questions and to participate in the final decision at his/her own preference and comfort levels. The intent is to test a decision aid for patients with advanced lung cancer to help facilitate informed decisions about treatments that affect quality of life, including termination of cancer-directed treatment. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Randomized, Open Label, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 8 | ||||
| Completion Date | March 2009 | ||||
| Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00579215 | ||||
| Responsible Party | Leslie Tyson, NP, Memorial Sloan-Kettering Cancer Center | ||||
| Study ID Numbers ICMJE | 06-141 | ||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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