Lung Cancer Informational Study (LCIS)

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.

Conditions

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

Interventions

BEHAVIORAL

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

BEHAVIORAL

Usual Care

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.

Sponsors & Collaborators

• University of Virginia

  collaborator OTHER

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Leslie B Tyson, NO · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-11-30

Primary Completion

2009-03-31

Completion

2009-03-31

Countries

• United States

Study Locations