Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

August 11, 2011
November 26, 2013
December 2008
April 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01416168 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colorectal Cancer
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.
  • 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.
    Intervention: Other: McCorkle Model Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
November 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01416168
MCC-15641
No
H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
  • Tampa General Hospital
  • University of South Florida
  • Yale University
Principal Investigator: Martine Extermann, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP