Clinical trial NCT01416168: Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
Official title: Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colon
Geriatric
McCorkle Model
Questionnaire
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Tampa General Hospital
name: University of South Florida
name: Yale University
First posted: 2011-08-12
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of the Intervention
timeFrame: 30 days per participant
Secondary outcomes:
measure: Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention
timeFrame: 30 days per participant
measure: A Successful Collection and Testing of >=90% of the Samples Tested
timeFrame: 30 days per participant
measure: Effect Size Estimates for Within-group Changes Between Baseline and 1-month
timeFrame: 30 days per participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Martine Extermann, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: