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

This study has been completed.
Sponsor:
Collaborators:
Tampa General Hospital
University of South Florida
Yale University
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01416168
First received: August 11, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Colorectal Cancer
Other: McCorkle Model Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Feasibility of the Intervention [ Time Frame: 30 days per participant ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention [ Time Frame: 30 days per participant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: December 2008
Study Completion Date: November 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01416168

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Tampa General Hospital
University of South Florida
Yale University
Investigators
Principal Investigator: Martine Extermann, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01416168     History of Changes
Other Study ID Numbers: MCC-15641
Study First Received: August 11, 2011
Last Updated: November 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Colon
Geriatric
McCorkle Model
Questionnaire

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 18, 2014