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Lung Cancer Informational Study (LCIS)

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Cancer, Enhanced Care, Decision-Making, Advance Lung Cancer, Stage III Lung Cancer, Stage IV Lung Cancer

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Trial Information

Lung Cancer Informational Study (LCIS)

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.

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)

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Leslie B Tyson, NO

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

November 2006

Completion Date:

March 2009

Related Keywords:

  • Cancer
  • Enhanced Care
  • Decision-Making
  • Advance Lung Cancer
  • Stage III Lung Cancer
  • Stage IV Lung Cancer
  • Cancer
  • Enhanced Care
  • Decision-Making
  • Advance Lung Cancer
  • Questionaires
  • Stage III Lung Cancer
  • Stage IV Lung Cancer
  • Lung Neoplasms



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Virginia- School of NursingCharlottesville, Virginia  22908