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

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Colorectal Cancer

Treatments: Other: McCorkle Model Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01416168

MCC-15641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Colorectal cancer, stage III or IV, confirmed by histology
• Abdominal surgery by a University of South Florida (USF) surgeon at Moffitt Cancer Center or Tampa General Hospital (TGH)
• Age 60 years and older
• Informed consent
• Living within a one (1) hour radius of Moffitt

Exclusion criteria

• Discharge planned to a rehabilitation facility or a nursing home
• Unable to answer the questionnaires (e.g. because of cognitive impairment, blindness, deafness)
• Post-operative inpatient stay >one (1) month

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Control Arm

No Intervention group

Description:

Usual post-surgical care

Intervention arm

Experimental group

Description:

In addition to usual post-surgical care, the patients will receive a 4 week geriatric nurse practitioner-centered intervention, based on the McCorkle model.

Treatment:

Other: McCorkle Model Intervention