Lung Cancer Informational Study (LCIS)

NCT00579215 | Completed

• 1 other identifier: 06-141
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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: Enhance Care

2

OTHER

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.

Behavioral: Usual Care

Interventions

Enhance Care BEHAVIORAL

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

Also known as: EC

1

Usual Care BEHAVIORAL

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.

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Virginia: collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Virginia- School of Nursing

Charlottesville, Virginia, 22908, United States

Location

Related Links

• Memorial Sloan-Kettering web site

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Leslie B Tyson, NO

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: November 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 18, 2009

Record last verified: 2009-03

Locations

US (2)