Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01416168|
Recruitment Status : Completed
First Posted : August 12, 2011
Last Update Posted : November 27, 2013
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Other: McCorkle Model Intervention||Not Applicable|
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 (intervention group).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||November 2013|
No Intervention: Control Arm
Usual post-surgical care
Experimental: Intervention arm
In addition to usual post-surgical care, the patients will receive a 4 week geriatric nurse practitioner-centered intervention, based on the McCorkle model.
Other: McCorkle Model Intervention
The intervention will consist each week in a home visit and a phone call. The GNP conducting the home visit will identify current problems using a comprehensive geriatric assessment (CGA) and record problems on the Intervention and Recommendation Data Sheet. In addition, the cases will be reviewed at a weekly Intervention Team meeting between the intervention GNP (VM, CV), the geriatrician (VP), and the intervention PI (JO). That team meeting will also record how intervention goals for the various problems are met, using the instruments and criteria developed during our pilot study5. To ensure optimal consistency and an up-to-date evidence-based approach over the 4 years of the intervention, treatment recommendations will be offered according to national evidence-based treatment guidelines.
- Feasibility of the Intervention [ Time Frame: 30 days per participant ]
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
- Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention [ Time Frame: 30 days per participant ]Aim 2 will be judged qualitatively. Dr. Ruth McCorkle and Dr. Janine Overcash will judge whether the intervention is faithful enough to Dr McCorkle's original intervention and whether it can be carried effectively by the trained personnel.
- A Successful Collection and Testing of >=90% of the Samples Tested [ Time Frame: 30 days per participant ]Aim 3 will be judged by assessing the percentage of tests that could or not be performed on the Moffitt patients.
- Effect Size Estimates for Within-group Changes Between Baseline and 1-month [ Time Frame: 30 days per participant ]Aim 4 will be assessed by the activities of daily living (ADL), instrumental activities of daily living (IADL), complications and FACT-colorectal (FACT-C) v.4 questionnaires at baseline and end of intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416168
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Martine Extermann, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|