Colorectal NeoplasmsNCT04358328
Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study
A study testing Comprehensive geriatric assessment (CGA) and care in people with Colorectal Neoplasms and Frailty, run by Sahlgrenska University Hospital at 2 sites in Sweden.
Trial summary
This multicentre randomized controlled trial aims to investigate whether an individualized comprehensive geriatric assessment (CGA) and care will improve postoperative results in frail elderly patients undergoing surgery for colorectal cancer. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Neoplasms, Frailty, CGA
- What is being tested?
- Comprehensive geriatric assessment (CGA) and care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Oct 2020to 31 Aug 2025
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Potentially curable colorectal cancer (according to cTNM)
- ≥ 70 years old
- Frailty (CFS-9 v2.0 score 4-8)
Who cannot join
- Palliative situation
- Unable to understand study information
- Acute surgery
- Terminally ill patient (CFS-9 9)
- Less than 6 months expected survival
- Not willing to participate
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, 41685
Elinor Bexe Lindskog, MD, PhD, 706-344647 ext. +46, elinor.bexe-lindskog@surgery.gu.se
- Recruiting
Department of Surgery, NU-Hospital/NÄL
Trollhättan, Västra Götalandsregionen, 46185
Mattias Prytz, MD, PhD, 010-435 35 23 ext. +46, mattias.prytz@vgregion.se
Maria Normann, MD, 010-435 36 06 ext. +46, maria.normann@vgregion.se
About this study
Official title: Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study Can Preoperative Comprehensive Geriatric Assessment and Care in Addition to Standard ERAS Protocol Reduce Mortality After Colorectal Surgery for Carcinoma in the Frail Elderly?
This multicentre randomized controlled trial aims to investigate whether an individualized comprehensive geriatric assessment (CGA) and care will improve postoperative results in frail elderly patients undergoing surgery for colorectal cancer. The study will take place in departments applying the ERAS-concept which is considered gold standard in colorectal surgery.
Read the detailed description
Colorectal cancer is the third most common cancer form in Sweden with an incidence of approximately 6000 new cases annually. It affects mainly elderly people; 65 % of patients diagnosed with colon- or rectal cancer are older than 65 years, and more than half are 70 years of age or older when diagnosed. Surgery is the treatment of choice for colon and rectal cancer if cure is to be achieved, sometimes in combination with radio- and/or chemotherapy. With increasing age many patients acquire other medical conditions which in turn can affect the patient's general status and thus impair their chances to recover from cancer treatment.
Age is a well-known risk factor for post-operative complications. Furthermore, it has been established that assessing frailty in elderly patients is a more precise way of detecting patients with increased vulnerability. In recent years increasing research has focused on frailty in regards of different medical conditions and treatments. A large amount of studies has also been conducted on the concept of frailty and surgery, and there is solid knowledge of the impact of frailty on outcome after surgery. It is also known that elderly frail patients suffers a higher risk of severe post-operative complications and morbidity compared to elderly non frail patients in the terms of elective surgery for colon- and rectal cancer.
Several different tools for determining and measuring frailty has been developed and studied. A commonly used definition is the accumulation of deficits model, which adds together a person's different diseases and disabilities. A widely used instrument based on this concept is the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS-9). It utilises a 9-point instrument to assess frailty. A score of 5 or more defines frailty, and the higher the score the more severe the degree of frailty. The instrument has been extensively studied and validated and is highly correlated to the degree of frailty as measured with much more extensive frailty tools. The instrument is easy to use and not very time-consuming which makes it practical to use in everyday clinical practice; therefore rendering it relevant to use in clinical studies.
As stated, there are evidence that the group of frail elderly patients have inferior results after colorectal surgery, compared to elderly non-frail patients. Comprehensive geriatric assessment (CGA) and care is a well-established and effective way of providing health care. It has been proven to be beneficial in terms of outcome after hospitalization for the group of frail elderly in various other settings. A multicentre randomized controlled trial conducted in Norway evaluated preoperative geriatric assessment prior to surgery for colorectal cancer in frail patients ≥ 65 years of age. The patients in the intervention group were assessed by a medical doctor specializing in geriatric medicine who gave individual advice regarding medical changes, exercise, nutrition etc. The median time of intervention before surgery was six days. The study could not show any significant differences in post-operative complications. Except having a brief time span for the intervention, the study was smaller than the initial estimation, with a total of 116 included patients. Another randomized controlled study has been conducted regarding prehabilitation prior to surgery for colorectal cancer in frail patients, analysing 30-day complications. The prehabilitation in this study consisted of exercise, nutritional and psychological interventions four weeks prior to surgery, and could not establish any differences in 30-day complications rates compared to a group that received rehabilitation four weeks after surgery. Further, there is an ongoing randomized controlled international study aiming to evaluate the impact of multimodal prehabilitation - in terms of exercise, nutritional and psychological interventions prior to colorectal surgery in adults, not specifically frail patients. There is also an ongoing randomized controlled study - the GERICO study - on frail elderly patients receiving chemotherapy for colorectal cancer with the aim to see if geriatric intervention affects outcome.
Intervention studies using CGA and care as an intervention to improve outcome for frail elderly patients has been conducted in terms om hip fracture and abdominal surgery, so far with mixed results. A systematic review of these studies from 2017 concluded that there is a need of a larger randomized multicentre study to evaluate the possible advantage of such an intervention for frail elderly patients prior to surgery.
- Conditions
- Colorectal Neoplasms, Frailty, CGA
- Being tested
- Comprehensive geriatric assessment (CGA) and care, Standard care
- Keywords
- Frailty, Elderly, Colorectal cancer, Comprehensive Geriatric Assessment
- Medical subject headings
- Colorectal Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive geriatric assessment (CGA) and careOther
Comprehensive geriatric assessment and care including geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions.
Standard careOther
Standard pre-, peri- and post operative care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients in the intervention arm will receive the same care and treatment as is provided to all patients in the clinical setting, including the ERAS-concept. In addition to this they will be individually assessed by a physician with geriatric profile, dietician, physiotherapist and nurse and thereafter undergo appropriate interventions (CGA and care). The intervention team will have weekly meetings regarding the patients included in the study to evaluate how long the intervention should continue before surgery, a maximum time of eight weeks will be allowed for the intervention. Receives: Other: Comprehensive geriatric assessment (CGA) and care |
| Control group | Active comparator | The patients in the control group will standard care and treatment which include assessment of surgeons, anaesthesiologists and, if needed, other specialized physicians. They will be treated according to the ERAS-concept in the pre- peri- and post operative phase. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
All cause mortality
Measured: 90 days
Secondary outcomes (10)
Hospital stay
Length of hospital stay and total number of hospital days within 3 months after discharge
Measured: 3 months
Discharge destination
Home or nursing facility, use of home help services. Information regarding where the patient was discharged after the hospital care will be gathered from the medical records. It will be noted if the patient was discharged to: own housing without home help services or home healthcare, own housing with assistance of home help services and/or home healthcare or to a nursing facility.
Measured: 2 months
Readmission
30 days readmission rates
Measured: 30 days
Acitivities of Daily Living (ADL)
ADL performance at follow up in comparison to baseline. ADL performance will be assessed using the ADL Staircase. This instrument evaluates a person's independence regarding nine functions: bathing, dressing, toileting, transferring, feeding, cooking, shopping, cleaning, and transportation. The results gives a score of 0-9 where 9 indicates complete dependence regarding all functions and 0 indicates full function.
Measured: 2 months
Safe medication assessment
Medication assessment at follow-up, by the instrument Safe medication assessment (SMA) and via clincial evalutation.
Measured: 2 months
Clinical Frailty Scale-9 (CFS-9)
CFS-9 score at follow up.
The CFS-9 scale is a validating scoring system for detecting frailty in elderly. The scale reaches from 0-9, patients reaching a score of 5-8 are considered to be frail. A higher number indicates increased frailty.
Measured: 2 months
Postoperative complications
According to the Clavien-Dindo scale. The Clavien-Dindo scale is a well-recognized tool for grading post-operative complications. The scale reaches from 1-5, where 1 is a minor complication and 5 is a deadly complication.
Measured: 2 months
Quality of Life (QoL)
Health related QoL at follow up, measured using the "EQ-5D-5L"-form. The form evaluates the patients self-experienced degree of mobility, self-care, usual activities, pain/discomfort and anxiety and depression. The scoring results in an index value which can be compared to a standard value of the general population in a region/country.
Measured: 12 months
Health economical calculations
Including cost-effectiveness based on costs of hospital care, primary care and municipal care; mortality, and quality of life (QoL).
Measured: 1 year
Mortality
All cause mortality
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- Model description
- Patients will be randomized into two parallel groups. This will result in two equally sized groups which will be stratified for the planned surgical procedure (colon- or rectal surgery), gender and age. One group will be randomized to preoperative geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions (CGA and care). The other group will be randomized to conventional preoperative assessments by anaesthesiologist and standard ERAS care. The study population is constituted of all patients in the participating hospitals with a newly diagnosed colorectal cancer available for colorectal cancer surgery with curative intent and who fulfil the inclusion criteria and no exclusion criteria.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mattias Prytz, NU-Hospital Organization, Sweden
- Investigators
- Mattias Prytz, MD, PhD, Principal investigator, Department of Surgery, NU-Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358328
- Sponsor's protocol ID
- Frailty-studien
- Status last verified
- Oct 2022
- First submitted
- 2 Apr 2020
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Okabe H, Ohsaki T, Ogawa K, Ozaki N, Hayashi H, Akahoshi S, Ikuta Y, Ogata K, Baba H, Takamori H. Frailty predicts severe postoperative complications after elective colorectal surgery. Am J Surg. 2019 Apr;217(4):677-681. doi: 10.1016/j.amjsurg.2018.07.009. Epub 2018 Nov 23.
PubMed 30473227Ommundsen N, Wyller TB, Nesbakken A, Bakka AO, Jordhoy MS, Skovlund E, Rostoft S. Preoperative geriatric assessment and tailored interventions in frail older patients with colorectal cancer: a randomized controlled trial. Colorectal Dis. 2018 Jan;20(1):16-25. doi: 10.1111/codi.13785.
PubMed 28649755Ommundsen N, Wyller TB, Nesbakken A, Jordhoy MS, Bakka A, Skovlund E, Rostoft S. Frailty is an independent predictor of survival in older patients with colorectal cancer. Oncologist. 2014 Dec;19(12):1268-75. doi: 10.1634/theoncologist.2014-0237. Epub 2014 Oct 29.
PubMed 25355846Tan KY, Kawamura YJ, Tokomitsu A, Tang T. Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized. Am J Surg. 2012 Aug;204(2):139-43. doi: 10.1016/j.amjsurg.2011.08.012. Epub 2011 Dec 16.
PubMed 22178483Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.
PubMed 24651133Pilotto A, Cella A, Pilotto A, Daragjati J, Veronese N, Musacchio C, Mello AM, Logroscino G, Padovani A, Prete C, Panza F. Three Decades of Comprehensive Geriatric Assessment: Evidence Coming From Different Healthcare Settings and Specific Clinical Conditions. J Am Med Dir Assoc. 2017 Feb 1;18(2):192.e1-192.e11. doi: 10.1016/j.jamda.2016.11.004. Epub 2016 Dec 31.
PubMed 28049616Indrakusuma R, Dunker MS, Peetoom JJ, Schreurs WH. Evaluation of preoperative geriatric assessment of elderly patients with colorectal carcinoma. A retrospective study. Eur J Surg Oncol. 2015 Jan;41(1):21-7. doi: 10.1016/j.ejso.2014.09.005. Epub 2014 Sep 18.
PubMed 25267000Normann M, Ekerstad N, Angenete E, Prytz M. Effect of comprehensive geriatric assessment for frail elderly patients operated for colorectal cancer-the colorectal cancer frailty study: study protocol for a randomized, controlled, multicentre trial. Trials. 2022 Nov 17;23(1):948. doi: 10.1186/s13063-022-06883-9.
PubMed 36397083
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study Can Preoperative Comprehensive Geriatric Assessment and Care in Addition to Standard ERAS Protocol Reduce Mortality After Colorectal Surgery for Carcinoma in the Frail Elderly?
- ClinicalTrials.gov ID
- NCT04358328
- Acronym / sponsor ID
- Frailty-studien
- Conditions
- Colorectal Neoplasms, Frailty, CGA
- Keywords
- Frailty, Elderly, Colorectal cancer, Comprehensive Geriatric Assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Apr 2020 (actual)
- 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 multicentre randomized controlled trial aims to investigate whether an individualized comprehensive geriatric assessment (CGA) and care will improve postoperative results in frail elderly patients undergoing surgery for colorectal cancer. The study will take place in departments applying the ERAS-concept which is considered gold standard in colorectal surgery.
Detailed description
Colorectal cancer is the third most common cancer form in Sweden with an incidence of approximately 6000 new cases annually. It affects mainly elderly people; 65 % of patients diagnosed with colon- or rectal cancer are older than 65 years, and more than half are 70 years of age or older when diagnosed. Surgery is the treatment of choice for colon and rectal cancer if cure is to be achieved, sometimes in combination with radio- and/or chemotherapy. With increasing age many patients acquire other medical conditions which in turn can affect the patient's general status and thus impair their chances to recover from cancer treatment.
Age is a well-known risk factor for post-operative complications. Furthermore, it has been established that assessing frailty in elderly patients is a more precise way of detecting patients with increased vulnerability. In recent years increasing research has focused on frailty in regards of different medical conditions and treatments. A large amount of studies has also been conducted on the concept of frailty and surgery, and there is solid knowledge of the impact of frailty on outcome after surgery. It is also known that elderly frail patients suffers a higher risk of severe post-operative complications and morbidity compared to elderly non frail patients in the terms of elective surgery for colon- and rectal cancer.
Several different tools for determining and measuring frailty has been developed and studied. A commonly used definition is the accumulation of deficits model, which adds together a person's different diseases and disabilities. A widely used instrument based on this concept is the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale (CFS-9). It utilises a 9-point instrument to assess frailty. A score of 5 or more defines frailty, and the higher the score the more severe the degree of frailty. The instrument has been extensively studied and validated and is highly correlated to the degree of frailty as measured with much more extensive frailty tools. The instrument is easy to use and not very time-consuming which makes it practical to use in everyday clinical practice; therefore rendering it relevant to use in clinical studies.
As stated, there are evidence that the group of frail elderly patients have inferior results after colorectal surgery, compared to elderly non-frail patients. Comprehensive geriatric assessment (CGA) and care is a well-established and effective way of providing health care. It has been proven to be beneficial in terms of outcome after hospitalization for the group of frail elderly in various other settings. A multicentre randomized controlled trial conducted in Norway evaluated preoperative geriatric assessment prior to surgery for colorectal cancer in frail patients ≥ 65 years of age. The patients in the intervention group were assessed by a medical doctor specializing in geriatric medicine who gave individual advice regarding medical changes, exercise, nutrition etc. The median time of intervention before surgery was six days. The study could not show any significant differences in post-operative complications. Except having a brief time span for the intervention, the study was smaller than the initial estimation, with a total of 116 included patients. Another randomized controlled study has been conducted regarding prehabilitation prior to surgery for colorectal cancer in frail patients, analysing 30-day complications. The prehabilitation in this study consisted of exercise, nutritional and psychological interventions four weeks prior to surgery, and could not establish any differences in 30-day complications rates compared to a group that received rehabilitation four weeks after surgery. Further, there is an ongoing randomized controlled international study aiming to evaluate the impact of multimodal prehabilitation - in terms of exercise, nutritional and psychological interventions prior to colorectal surgery in adults, not specifically frail patients. There is also an ongoing randomized controlled study - the GERICO study - on frail elderly patients receiving chemotherapy for colorectal cancer with the aim to see if geriatric intervention affects outcome.
Intervention studies using CGA and care as an intervention to improve outcome for frail elderly patients has been conducted in terms om hip fracture and abdominal surgery, so far with mixed results. A systematic review of these studies from 2017 concluded that there is a need of a larger randomized multicentre study to evaluate the possible advantage of such an intervention for frail elderly patients prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized into two parallel groups. This will result in two equally sized groups which will be stratified for the planned surgical procedure (colon- or rectal surgery), gender and age. One group will be randomized to preoperative geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions (CGA and care). The other group will be randomized to conventional preoperative assessments by anaesthesiologist and standard ERAS care. The study population is constituted of all patients in the participating hospitals with a newly diagnosed colorectal cancer available for colorectal cancer surgery with curative intent and who fulfil the inclusion criteria and no exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Comprehensive geriatric assessment (CGA) and careThe patients in the intervention arm will receive the same care and treatment as is provided to all patients in the clinical setting, including the ERAS-concept. In addition to this they will be individually assessed by a physician with geriatric profile, dietician, physiotherapist and nurse and thereafter undergo appropriate interventions (CGA and care). The intervention team will have weekly meetings regarding the patients included in the study to evaluate how long the intervention should continue before surgery, a maximum time of eight weeks will be allowed for the intervention. |
| Control group | Active comparator | Other: Standard careThe patients in the control group will standard care and treatment which include assessment of surgeons, anaesthesiologists and, if needed, other specialized physicians. They will be treated according to the ERAS-concept in the pre- peri- and post operative phase. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Potentially curable colorectal cancer (according to cTNM)
- ≥ 70 years old
- Frailty (CFS-9 v2.0 score 4-8)
Key exclusion criteria (6 listed)
- Palliative situation
- Unable to understand study information
- Acute surgery
- Terminally ill patient (CFS-9 9)
- Less than 6 months expected survival
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 |
|---|---|---|
| Comprehensive geriatric assessment (CGA) and careComprehensive geriatric assessment and care including geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions. | Other | Intervention group |
| Standard careStandard pre-, peri- and post operative care. | Other | Control group |
Primary outcome
Mortality
Time frame: 90 days
All cause mortality
10 secondary outcomes
Hospital stay
Time frame: 3 months
Discharge destination
Time frame: 2 months
Readmission
Time frame: 30 days
Acitivities of Daily Living (ADL)
Time frame: 2 months
Safe medication assessment
Time frame: 2 months
Clinical Frailty Scale-9 (CFS-9)
Time frame: 2 months
Postoperative complications
Time frame: 2 months
Quality of Life (QoL)
Time frame: 12 months
Health economical calculations
Time frame: 1 year
Mortality
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Background: PubMed 30473227Okabe H, Ohsaki T, Ogawa K, Ozaki N, Hayashi H, Akahoshi S, Ikuta Y, Ogata K, Baba H, Takamori H. Frailty predicts severe postoperative complications after elective colorectal surgery. Am J Surg. 2019 Apr;217(4):677-681. doi: 10.1016/j.amjsurg.2018.07.009. Epub 2018 Nov 23.
- Background: PubMed 28649755Ommundsen N, Wyller TB, Nesbakken A, Bakka AO, Jordhoy MS, Skovlund E, Rostoft S. Preoperative geriatric assessment and tailored interventions in frail older patients with colorectal cancer: a randomized controlled trial. Colorectal Dis. 2018 Jan;20(1):16-25. doi: 10.1111/codi.13785.
- Background: PubMed 25355846Ommundsen N, Wyller TB, Nesbakken A, Jordhoy MS, Bakka A, Skovlund E, Rostoft S. Frailty is an independent predictor of survival in older patients with colorectal cancer. Oncologist. 2014 Dec;19(12):1268-75. doi: 10.1634/theoncologist.2014-0237. Epub 2014 Oct 29.
- Background: PubMed 22178483Tan KY, Kawamura YJ, Tokomitsu A, Tang T. Assessment for frailty is useful for predicting morbidity in elderly patients undergoing colorectal cancer resection whose comorbidities are already optimized. Am J Surg. 2012 Aug;204(2):139-43. doi: 10.1016/j.amjsurg.2011.08.012. Epub 2011 Dec 16.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Background: PubMed 24651133Reisinger KW, van Vugt JL, Tegels JJ, Snijders C, Hulsewe KW, Hoofwijk AG, Stoot JH, Von Meyenfeldt MF, Beets GL, Derikx JP, Poeze M. Functional compromise reflected by sarcopenia, frailty, and nutritional depletion predicts adverse postoperative outcome after colorectal cancer surgery. Ann Surg. 2015 Feb;261(2):345-52. doi: 10.1097/SLA.0000000000000628.
- Background: PubMed 28049616Pilotto A, Cella A, Pilotto A, Daragjati J, Veronese N, Musacchio C, Mello AM, Logroscino G, Padovani A, Prete C, Panza F. Three Decades of Comprehensive Geriatric Assessment: Evidence Coming From Different Healthcare Settings and Specific Clinical Conditions. J Am Med Dir Assoc. 2017 Feb 1;18(2):192.e1-192.e11. doi: 10.1016/j.jamda.2016.11.004. Epub 2016 Dec 31.
- Background: PubMed 25267000Indrakusuma R, Dunker MS, Peetoom JJ, Schreurs WH. Evaluation of preoperative geriatric assessment of elderly patients with colorectal carcinoma. A retrospective study. Eur J Surg Oncol. 2015 Jan;41(1):21-7. doi: 10.1016/j.ejso.2014.09.005. Epub 2014 Sep 18.
- Derived from this study: PubMed 36397083Normann M, Ekerstad N, Angenete E, Prytz M. Effect of comprehensive geriatric assessment for frail elderly patients operated for colorectal cancer-the colorectal cancer frailty study: study protocol for a randomized, controlled, multicentre trial. Trials. 2022 Nov 17;23(1):948. doi: 10.1186/s13063-022-06883-9.
- Individual participant dataSharing planned: No
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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.
Mattias Prytz, MD, PhD principal investigator
Department of Surgery, NU-Hospital Organization
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive geriatric assessment (CGA) and care in people with Colorectal Neoplasms and Frailty, run by Sahlgrenska University Hospital at 2 sites in Sweden.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mattias Prytz, MD, PhD (010-4353523 ext. +46, mattias.prytz@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358328, which also lists 9 linked publications.
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 1 Nov 2022.