NCT01416168

Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Surgery for colorectal cancer is a major surgery. People above the age of 60 tend to have a higher risk of complications. Some studies indicate that senior cancer patients might benefit from a home support after surgery by a geriatric nurse practitioner and a team, beside their usual post-operative care. The investigators team is planning a large study to assess whether this approach could help patients with colorectal cancer recover better from their surgery, get better cancer treatment after that (e.g. chemotherapy), and possibly live longer. This study you are asked to take part in is a pilot for this large study.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-04-01
• Completion: 2013-11-01
• First posted: 2011-08-12
• Last updated: 2013-11-27

Locations

1 site across 1 country: United States