Palliative Care and Phase 1 Trials: Intervention to Improve Quality of Life and Provide Education .
Betty R Ferrell, Vincent Chung, Marianna Koczywas and 4 others
PMID 28738035WHAT IT FOUND
Pain scores fell from 6/10 to 2/10 in a Phase 1 trial patient receiving vaccine and gemcitabine, fentanyl, oxycodone, Senekot, Zofran, hydration, stent replacement, chaplaincy, social work, nutrition, and palliative care.
This is a single case, not proof it works.
Key findings
01The paper describes an ongoing randomized trial testing a palliative care intervention for solid tumor patients in Phase 1 trials, with randomization assigned through the statistical center and 180 patients accrued.
02In the case example, a 49-year-old woman on a Phase 1 trial had two teaching sessions, an advance directive, and a pain plan with a fentanyl patch, oxycodone, and Senekot.
03In the case example, pain score fell from 6/10 to 2/10 and anxiety decreased, but the patient also received vaccine and gemcitabine, fentanyl, oxycodone, Senekot, Zofran, hydration, stent replacement, chaplaincy, social work, nutrition, and palliative care, so the contribution of any single component cannot be separated.
STILL TO COME
How it was doneWhat they foundWhat it means for RNs
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What it does not show
The randomized trial was still in progress, in year 3 of 5 with 180 patients accrued, so it provides no completed trial evidence that the intervention improves quality of life. The case example describes a patient, so her pain reduction, advance directive, and hospice transition cannot be generalized to other Phase 1 trial patients. The case patient received many treatments at once, including the Phase 1 trial drug, fentanyl patch, oxycodone, Senekot, IV Zofran, hydration, stent replacement, chaplaincy, social work, nutrition, and palliative care, so the effect of any single component cannot be separated. The usual care group was offered the intervention after 12-week data collection, so later comparisons may be affected because usual care patients could receive the intervention after 12 weeks.
Declared interests
The ongoing study was funded by the National Cancer Institute.
The easy way to misread this
Do not conclude that palliative care improves quality of life or survival in Phase 1 trial patients from this paper. The randomized trial was still in progress, and the case example describes a patient who also received vaccine and gemcitabine, fentanyl, oxycodone, Senekot, Zofran, hydration, stent replacement, chaplaincy, social work, nutrition, and palliative care and hospice.