Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
This study is currently recruiting participants.
(see Contacts and Locations)
Verified January 2014 by Oslo University Hospital
Sponsor:
Oslo University Hospital
Collaborators:
Norwegian Cancer Society
University Hospital, Akershus
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01321658
First received: March 18, 2011
Last updated: January 17, 2014
Last verified: January 2014
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Purpose
This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.
The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.
| Condition | Intervention |
|---|---|
|
Colorectal Neoplasms |
Other: Geriatric intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial. |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
Primary Outcome Measures:
- Postoperative complications [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reoperation [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
- Readmission [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
- Length of hospital stay [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
- Survival [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
- Living at home or in institution [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2011 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Geriatric intervention |
Other: Geriatric intervention
A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.
|
| No Intervention: Control |
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 65+
- Elective surgery for colorectal cancer
- Frail
Exclusion Criteria:
- Acute surgery
- Not able to consent
- Does not consent with registration
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: NCT01321658
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321658
Contacts
| Contact: Nina Ommundsen, MD | +4740225685 | ninaommundsen@gmail.com | |
| Contact: Torgeir Bruun Wyller, Dr.med | +4722118702 | t.b.wyller@medisin.uio.no |
Locations
| Norway | |
| Dept of gastrointestinal surgery, Oslo University Hospital | Recruiting |
| Oslo, Norway, 0424 | |
| Contact: Nina Ommundsen, MD +4740225685 ninaommundsen@gmail.com | |
| Contact: Hans-Olaf Johannessen, dr.med uxhojo@ous-hf.no | |
| Principal Investigator: Nina Ommundsen, MD | |
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
University Hospital, Akershus
Investigators
| Study Chair: | Torgeir B Wyller, Dr.med | Geriatric dept., Oslo University hospital |
More Information
No publications provided
| Responsible Party: | Professor Torgeir Bruun Wyller, Dept of geriatric medicine, Oslo University hospital |
| ClinicalTrials.gov Identifier: | NCT01321658 History of Changes |
| Other Study ID Numbers: | 2010/1634 |
| Study First Received: | March 18, 2011 |
| Last Updated: | January 17, 2014 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Oslo University Hospital:
|
Geriatric Assessment Perioperative Care Colorectal Neoplasms Frail Elderly |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases |
ClinicalTrials.gov processed this record on March 03, 2015