Non-Small-Cell Lung Cancer Clinical Trial
— LCIS-R01Official title:
A Decision Aid With Health-Related Quality of Life (HRQL) Assessment to Reduce Costs in the Treatment of Non-Small Cell Lung Cancer (NSCLC)
Verified date | February 2018 |
Source | University of Virginia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary specific aim is to test the hypothesis that use of a decision aid to enhance informed, shared decision making coupled with quality of life assessment 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; number of advanced imaging studies) compared with the control arm.
Status | Completed |
Enrollment | 196 |
Est. completion date | February 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of Virginia | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | A reduction in two major contributors of cost: Number of chemotherapy cycles, and number of advanced imaging studies | Number of chemotherapy cycles administered and number of advanced imaging studies (CT, MRI, PET) related to treatment decisions | 9 weeks | |
Secondary | QL-PRO assessment | Change in QL-PRO assessment at each new cycle to help in informed, shared decision making | Every three weeks for 3 cycles, an expected average of 9 weeks | |
Secondary | Decisional conflict | Change in decisional conflict for three treatment decisions: Decision 1 (Starting Chemotherapy); Decision 2 (Changing Chemotherapy); Decision 3 (Stopping Anti-Cancer Treatment) |
Pre-post each of three decisions during chemotherapy treament, an expected average of 10 months | |
Secondary | Decisional regret | Degree of decisional regret after each of three treatment decisions: Decision 1 (Starting Chemotherapy); Decision 2 (Changing Chemotherapy); Decision 3 (Stopping Anti-Cancer Treatment) |
Post each of three decisions during chemotherapy treatment, an expected average of 10 months | |
Secondary | Overall decisional regret | Degree of decisional regret after completion of treatment (1-2 weeks followup telephone contact) | 1-2 weeks followup at end of chemotherapy treatment, an expected average of 10 months |
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