Colorectal NeoplasmsNCT01321658
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
A study testing Geriatric intervention in people with Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Geriatric intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2011to Oct 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65+
- Elective surgery for colorectal cancer
- Frail
Who cannot join
- Acute surgery
- Not able to consent
- Does not consent with registration
Trial locations and contacts
1 site in 1 country.
Norway1 site
Dept of gastrointestinal surgery, Oslo University Hospital
Oslo, 0424
About this study
Official title: Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Geriatric intervention
- Keywords
- Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric intervention | Experimental | Not described Receives: Other: Geriatric intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Measured: 30 days after surgery
Secondary outcomes (6)
Reoperation
Number of patients in need of any operation within thirty days after the operation for colorectal cancer.
Measured: 30 days after surgery
Readmission
Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.
Measured: 30 days after surgery
Length of hospital stay
Measured: 30 days after surgery
Survival
Measured: 3 months after surgery
Quality of life
Measured: 3 months after surgery
Living at home or in institution
Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, University Hospital, Akershus
- Responsible party
- Principal investigator, Torgeir Bruun Wyller, Oslo University Hospital
- Investigators
- Torgeir B Wyller, Dr.med, Study chair, Geriatric dept., Oslo University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321658
- Sponsor's protocol ID
- 2010/1634
- Status last verified
- Oct 2015
- First submitted
- 18 Mar 2011
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT01321658
- Acronym / sponsor ID
- 2010/1634
- Conditions
- Colorectal Neoplasms
- Keywords
- Geriatric Assessment, Perioperative Care, Colorectal Neoplasms, Frail Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, University Hospital, Akershus
- Study start
- Feb 2011
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Mar 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatric intervention | Experimental | Other: Geriatric intervention |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65+
- Elective surgery for colorectal cancer
- Frail
Key exclusion criteria (3 listed)
- Acute surgery
- Not able to consent
- Does not consent with registration
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 |
|---|---|---|
| Geriatric interventionA 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. | Other | Geriatric intervention |
Primary outcome
Postoperative complications
Time frame: 30 days after surgery
6 secondary outcomes
Reoperation
Time frame: 30 days after surgery
Readmission
Time frame: 30 days after surgery
Length of hospital stay
Time frame: 30 days after surgery
Survival
Time frame: 3 months after surgery
Quality of life
Time frame: 3 months after surgery
Living at home or in institution
Time frame: 3 months after surgery
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 21 Oct 2015.
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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.
Torgeir B Wyller, Dr.med study chair
Geriatric dept., Oslo University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric intervention in people with Colorectal Neoplasms, run by Oslo University Hospital at 1 site in Norway.
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 3 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 21 Oct 2015. 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 Norway. 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?
Postoperative complications (time frame: 30 days after surgery). 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 21 Oct 2015.