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

NCT01416168 | Completed

• 1 other identifier: MCC-15641
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colon; Geriatric; McCorkle Model; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Feasibility of the Intervention

  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

  30 days per participant

Secondary Outcomes (3)

• Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention

  30 days per participant

• A Successful Collection and Testing of >=90% of the Samples Tested

  30 days per participant

• Effect Size Estimates for Within-group Changes Between Baseline and 1-month

  30 days per participant

Study Arms (2)

Control Arm

NO INTERVENTION

Usual post-surgical care

Intervention arm

EXPERIMENTAL

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

Interventions

McCorkle Model Intervention OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Tampa General Hospital: collaborator
• University of South Florida: collaborator
• Yale University: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Martine Extermann, M.D., Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2011
• First Posted: August 12, 2011
• Study Start: December 1, 2008
• Primary Completion: April 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 27, 2013

Record last verified: 2013-11

Locations

US (1)