Colorectal CancerNCT01416168
Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
A study testing McCorkle Model Intervention in people with Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- McCorkle Model Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- McCorkle Model Intervention
- Keywords
- Colon, Geriatric, McCorkle Model, Questionnaire
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McCorkle Model InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: McCorkle Model Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days per participant
Secondary outcomes (3)
Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention
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.
Measured: 30 days per participant
A Successful Collection and Testing of >=90% of the Samples Tested
Aim 3 will be judged by assessing the percentage of tests that could or not be performed on the Moffitt patients.
Measured: 30 days per participant
Effect Size Estimates for Within-group Changes Between Baseline and 1-month
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.
Measured: 30 days per participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startDec 2008
- Primary completionApr 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tampa General Hospital, University of South Florida, Yale University
- Responsible party
- Sponsor
- Investigators
- Martine Extermann, M.D., Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416168
- Sponsor's protocol ID
- MCC-15641
- Status last verified
- Nov 2013
- First submitted
- 11 Aug 2011
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Geriatric Intervention After Colorectal and Lung Cancer Surgery
- ClinicalTrials.gov ID
- NCT01416168
- Acronym / sponsor ID
- MCC-15641
- Conditions
- Colorectal Cancer
- Keywords
- Colon, Geriatric, McCorkle Model, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Tampa General Hospital, University of South Florida, Yale University
- Study start
- Dec 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Usual post-surgical care |
| Intervention arm | Experimental | Other: McCorkle Model InterventionIn addition to usual post-surgical care, the patients will receive a 4 week geriatric nurse practitioner-centered intervention, based on the McCorkle model. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| McCorkle Model InterventionThe 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. | Other | Intervention arm |
Primary outcome
Feasibility of the Intervention
Time frame: 30 days per participant
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
3 secondary outcomes
Whether the Intervention is Faithful to Dr. McCorkle's Original Intervention
Time frame: 30 days per participant
A Successful Collection and Testing of >=90% of the Samples Tested
Time frame: 30 days per participant
Effect Size Estimates for Within-group Changes Between Baseline and 1-month
Time frame: 30 days per participant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine Extermann, M.D., Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing McCorkle Model Intervention in people with Colorectal Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (time frame: 30 days per participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2013.