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Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study

Primary Purpose

Colorectal Neoplasms, Frailty, CGA

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Comprehensive geriatric assessment (CGA) and care
Standard care
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms focused on measuring Frailty, Elderly, Colorectal cancer, Comprehensive Geriatric Assessment

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Potentially curable colorectal cancer (according to cTNM)
  • ≥ 70 years old
  • Frailty (CFS-9 v2.0 score 4-8)

Exclusion Criteria:

  • 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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting
  • Department of Surgery, NU-Hospital/NÄLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mortality
All cause mortality

Secondary Outcome Measures

Hospital stay
Length of hospital stay and total number of hospital days within 3 months after discharge
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.
Readmission
30 days readmission rates
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.
Safe medication assessment
Medication assessment at follow-up, by the instrument Safe medication assessment (SMA) and via clincial evalutation.
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.
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.
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.
Health economical calculations
Including cost-effectiveness based on costs of hospital care, primary care and municipal care; mortality, and quality of life (QoL).
Mortality
All cause mortality

Full Information

First Posted
April 2, 2020
Last Updated
October 31, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT04358328
Brief Title
Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-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?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Frailty, CGA
Keywords
Frailty, Elderly, Colorectal cancer, Comprehensive Geriatric Assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
It will not be possible to mask for either patients nor participating health care professionals if patients are enrolled in the control- or intervention group. Hence, the study will not be blinded. When the final data analysis is performed the person performing the analysis will not be aware of which group each patient was a part of.
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive geriatric assessment (CGA) and care
Intervention Description
Comprehensive geriatric assessment and care including geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard pre-, peri- and post operative care.
Primary Outcome Measure Information:
Title
Mortality
Description
All cause mortality
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Hospital stay
Description
Length of hospital stay and total number of hospital days within 3 months after discharge
Time Frame
3 months
Title
Discharge destination
Description
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.
Time Frame
2 months
Title
Readmission
Description
30 days readmission rates
Time Frame
30 days
Title
Acitivities of Daily Living (ADL)
Description
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.
Time Frame
2 months
Title
Safe medication assessment
Description
Medication assessment at follow-up, by the instrument Safe medication assessment (SMA) and via clincial evalutation.
Time Frame
2 months
Title
Clinical Frailty Scale-9 (CFS-9)
Description
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.
Time Frame
2 months
Title
Postoperative complications
Description
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.
Time Frame
2 months
Title
Quality of Life (QoL)
Description
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.
Time Frame
12 months
Title
Health economical calculations
Description
Including cost-effectiveness based on costs of hospital care, primary care and municipal care; mortality, and quality of life (QoL).
Time Frame
1 year
Title
Mortality
Description
All cause mortality
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Potentially curable colorectal cancer (according to cTNM) ≥ 70 years old Frailty (CFS-9 v2.0 score 4-8) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mattias Prytz, MD, PhD
Phone
010-4353523
Ext
+46
Email
mattias.prytz@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Normann, MD
Phone
010-4353606
Ext
+46
Email
maria.normann@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mattias Prytz, MD, PhD
Organizational Affiliation
Department of Surgery, NU-Hospital Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
State/Province
Västra Götalandsregionen
ZIP/Postal Code
41685
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elinor Bexe Lindskog, MD, PhD
Phone
706-344647
Ext
+46
Email
elinor.bexe-lindskog@surgery.gu.se
Facility Name
Department of Surgery, NU-Hospital/NÄL
City
Trollhättan
State/Province
Västra Götalandsregionen
ZIP/Postal Code
46185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mattias Prytz, MD, PhD
Phone
010-435 35 23
Ext
+46
Email
mattias.prytz@vgregion.se
First Name & Middle Initial & Last Name & Degree
Maria Normann, MD
Phone
010-435 36 06
Ext
+46
Email
maria.normann@vgregion.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30473227
Citation
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.
Results Reference
background
PubMed Identifier
28649755
Citation
Ommundsen 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.
Results Reference
background
PubMed Identifier
25355846
Citation
Ommundsen 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.
Results Reference
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PubMed Identifier
22178483
Citation
Tan 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.
Results Reference
background
PubMed Identifier
16129869
Citation
Rockwood 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.
Results Reference
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PubMed Identifier
24651133
Citation
Reisinger 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.
Results Reference
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PubMed Identifier
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Citation
Pilotto 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.
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Citation
Indrakusuma 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.
Results Reference
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PubMed Identifier
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Citation
Normann 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.
Results Reference
derived

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Effect of CGA for Frail Elderly Patients Operated for Colorectal Cancer - The CRC Frailty-study

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