Lung Cancer Information Study (LCIS-R01)

Appropriate utilization of treatment with systemic therapy remains problematic in advanced
lung cancer. A major issue continues to be over-treatment. Contributors to this include
barriers in communication concerning patients' wishes and goals, lack of formal monitoring
of symptoms using validated health-related quality of life (QL) and patient reported
outcomes (PROs) assessment, and over-dependence on imaging studies as the major and often
sole assessment tool. All of these factors make quality decision making more difficult and
can lead to decisional conflict and patient and family regret with treatment. The primary
specific aim is to test the hypothesis that use of a decision aid to enhance informed,
shared decision making coupled with QL assessment with immediate results in patients with
advanced lung cancer receiving first, second, or third-line therapy will lead to a reduction
in two major contributors of cost (number of chemotherapy cycles administered and the number
of advanced imaging studies [CT, MRI, PET] related to treatment decisions) compared with the
control arm. Secondary aims are: 1) To test the hypothesis that patients with advanced lung
cancer who receive an intervention decision aid coupled with immediate QL-PRO results) will
have reduced decisional conflict, and reduced decisional regret related to the
decision-making process, than those who do not; and 2) to explore the hypothesis that
patients with advanced lung cancer who have greater agreement with their chosen supporter
(less difference in perception of QL-PROs between the patient and the supporter) will have
fewer chemotherapy cycles, than those who do not have close agreement. This phase III,
two-arm, prospective, randomized clinical trial (RCT) will test the use of a decision aid
("DecisionKEYS") for patients with advanced lung cancer and coupled with the validated,
Electronic Lung Cancer Symptom Scale ("eLCSS-QL") to provide immediate QL-PRO results over
the treatment period. A repeated measures design will obtain QL assessment at baseline,
every 3 weeks while chemotherapy is given, and at the completion of chemotherapy. This study
will use a pretest/ posttest design covering timing for each of three consequential
decisions of cancer chemotherapy: Decision 1 ("Starting Chemotherapy"), Decision 2
("Changing Chemotherapy"), and Decision 3 ("Stopping Anti-Cancer Treatment"). There will be
three entry points: patients can be entered into the trial either at their initial
chemotherapy, or at the time of starting 1st-, 2nd- or 3rd-line chemotherapy. A stratified
block randomization design will be used in which strata are determined by two variables:
line of therapy and presenting quality of life. This RCT will be conducted in the outpatient
setting at three cancer centers in three states. The sample will include 196 patients with
advanced non-small cell lung cancer and their chosen supporter (if available). The sampling
plan will include serially screening the clinic appointment roster in the clinics. QL-PRO
assessment, decisional conflict, and decisional regret will be used to evaluate response to
the decision aid. A specific protocol will be followed by the physician and study nurse at
each visit. Descriptive statistics, subgroup analyses (t-test), and Generalized Linear Model
(GLM) method will be used for analyses.

A. Inclusion criteria for lung cancer subject:

1. Pathologically or cytologically determined non-small cell lung cancer (NSCLC)

2. Receiving either first-line, second-line, or third-line chemotherapy for advanced
NSCLC. Any chemotherapy will be acceptable

3. Stage IIIB or IV

4. Performance status of KPS 60-100% or ECOG 0-2

5. Hematologic and metabolic parameters suitable for chemotherapy

6. Patients previously treated with adjuvant therapy who now have recurrent NSCLC, will
be included as receiving first line therapy

7. Patients with brain metastasis are eligible provided: they are at least 1 week from
completion of surgery or RT for brain metastasis, have stable and adequate
neurological status to proceed with chemotherapy, and meet all other eligibility
criteria

8. Patients with prior cancer diagnoses (with or without prior chemotherapy), are
eligible provided the previous malignancy is well controlled

9. Ages greater than 18 with NSCLC

10. Life expectancy greater than three months

11. Able to understand English or Spanish, but is not required to be literate

B. Exclusion criteria for lung cancer subject:

1. Patients treated with molecular targeted therapy as their sole treatment

2. Patients with documented severe psychiatric diagnoses from the medical record, which
may prevent full study participation

3. Patients receiving protocol chemotherapy that mandates either the number of cycles of
treatment to be received or a fixed schedule of imaging studies

4. Patients receiving concomitant chemotherapy and radiation therapy are not eligible
for this protocol

5. Patients who are prisoners

6. Patients who are pregnant (self reporting by patient)

7. Patients who are cognitively impaired

C. Inclusion criteria for supporter:

1. Ages greater than 18

2. Able to understand English or Spanish, but is not required to be literate

D. Exclusion criteria for supporter:

1. Prisoners

2. Patients who are cognitively impaired