N/A
N=151
Palliative Care Interventions for Outpatients Newly Diagnosed With Lung Cancer: Phase II
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03007953 ↗Enrolled (actual)
151
Serious AEs
19.9%
Results posted
Oct 2021
Primary outcome: Primary: Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit — 1.8; -1.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Palliative Care (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Functional Assessment of Cancer Therapy-Lung Total Outcome Index Score at Final Visit |
1.8; -1.2 | — |
| SECONDARY Change From Baseline in Patient Satisfaction of Care at Final Visit |
1.1; 0.5 | — |
Summary
The focus of the study is to test a nurse-led telephone-based palliative care intervention on improving the delivery of care for patients with newly diagnosed lung cancer. The study is a three site randomized control trial to determine the efficacy of the intervention on improving patients' quality of life, symptom burden, and satisfaction of care. Additionally, the study will test an innovative care delivery model to improve patients' access to palliative care. The investigators will also determine the effect of the intervention on patient activation to discuss treatment preferences with their clinician and on clinician knowledge of patients' goals of care.
Eligibility Criteria
Inclusion Criteria
Patients diagnosed at the Puget Sound Health Care System, Birmingham VA, or Portland VA with a primary diagnosis of lung cancer that requires more than surgical resection:
- diagnosed within 8 weeks of recruitment
- must have telephone access
- ability to understand English
- able to participate in informed consent process
Exclusion Criteria
Patients not eligible to participate in the study include those who are inpatients prior to randomization,
- those who are under the care of palliative care or hospice at the time of randomization
- those who have severe mental health disorders
- those who are unable to speak directly with the nurse over the telephone
- or those that have the inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03007953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.