Clinical trial · Interventional
Lung Cancer Informational Study (LCIS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advance Lung Cancer | Lung Neoplasm | PROBABILISTIC | 0.70 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Decision-Making | — | UNRESOLVED | — |
| Enhanced Care | — | UNRESOLVED | — |
| Stage III Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Lung Cancer | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enhance Care | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 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.
- interventionNames
- Behavioral: Enhance Care
- type
- OTHER
- label
- 2
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available