Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
| Tracking Information | |||||
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| First Received Date ICMJE | August 11, 2011 | ||||
| Last Updated Date | April 30, 2013 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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:
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01416168 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery | ||||
| Official Title ICMJE | Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 15 | ||||
| Estimated Completion Date | October 2013 | ||||
| Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01416168 | ||||
| Other Study ID Numbers ICMJE | MCC-15641 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Study Sponsor ICMJE | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | H. Lee Moffitt Cancer Center and Research Institute | ||||
| Verification Date | April 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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