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


N/A
60 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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
(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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility of the Intervention

Outcome Description:

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

Outcome Time Frame:

30 days per participant

Safety Issue:

No

Principal Investigator

Martine Extermann, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Institutional Review Board

Study ID:

MCC-15641

NCT ID:

NCT01416168

Start Date:

December 2008

Completion Date:

October 2013

Related Keywords:

  • Colorectal Cancer
  • Colon
  • Geriatric
  • McCorkle Model
  • Questionnaire
  • Colorectal Neoplasms
  • Lung Neoplasms

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612