Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
Our key background data come from the randomized study conducted by McCorkle et al.
After evaluation testing, patients will be randomly assigned (similarly to a coin toss) to
one of two possible follow-up groups. One would be a regular post-surgery care group
(control group), the other will have in addition a support by geriatric nurse practitioner
Patients who are assigned to the intervention group: once they arrive home, in addition to
their normal post-surgery care, will receive a once a week home visit by a geriatric nurse
practitioner (GNP). The GNP will also call the patient once a week in between. The GNP will
check any problem patients may have during their recovery and provide or organize care for
it. The GNP has a checklist of problems to address so that we can reliably reproduce our
intervention in other patients. The GNP will work together with the patient's various
doctors and caregivers, as well as a geriatric team. Some of the visits or the telephone
calls maybe tape-recorded so that the research team can evaluate the information provided to
the patient. We will record any complication patients might have from surgery.
No matter which treatment group the patient is assigned to, at the end of a 4 weeks period,
we will repeat the tests we did at the beginning to see how they change.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Feasibility of the Intervention
The primary end-point for the pilot will be the feasibility of the intervention, measured as follows: A compliance of >=90% with the intervention table on page 17 A success rate (improvement or resolution of problems) of >= 80% A completion rate of >=90% of the initial and final study questionnaires
30 days per participant
Martine Extermann, M.D., Ph.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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