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

NCT04358328 | Unknown

• 1 other identifier: Frailty-studien
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 2

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.

Conditions

Colorectal Neoplasms; Frailty; CGA

Keywords

Frailty; Elderly; Colorectal cancer; Comprehensive Geriatric Assessment

Outcome Measures

Primary Outcomes (1)

• Mortality

  All cause mortality

  90 days

Secondary Outcomes (10)

• Hospital stay

  3 months

• Discharge destination

  2 months

• Readmission

  30 days

• Acitivities of Daily Living (ADL)

  2 months

• Safe medication assessment

  2 months

Study Arms (2)

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.

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.

Other: Standard care

Interventions

Comprehensive geriatric assessment (CGA) and care OTHER

Comprehensive geriatric assessment and care including geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions.

Intervention group

Standard care OTHER

Standard pre-, peri- and post operative care.

Control group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (2)

Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41685, Sweden

RECRUITING

Department of Surgery, NU-Hospital/NÄL

Trollhättan, Västra Götalandsregionen, 46185, Sweden

RECRUITING

Related Publications (9)

• 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.

  PMID: 30473227 BACKGROUND

• 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.

  PMID: 28649755 BACKGROUND

• 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.

  PMID: 25355846 BACKGROUND

• 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.

  PMID: 22178483 BACKGROUND

• 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.

  PMID: 16129869 BACKGROUND

• 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.

  PMID: 24651133 BACKGROUND

• 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.

  PMID: 28049616 BACKGROUND

• 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.

  PMID: 25267000 BACKGROUND

• 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.

  PMID: 36397083 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Frailty

Interventions

Geriatric Assessment; Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health; Quality Indicators, Health Care; Health Services Administration

Study Officials

• Mattias Prytz, MD, PhD

  Department of Surgery, NU-Hospital Organization

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Prytz, MD, PhD

CONTACT

010-4353523; mattias.prytz@vgregion.se

Maria Normann, MD

CONTACT

010-4353606; maria.normann@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant surgeon, MD, PhD. Head of the Colorectal department, Department of Surgery, NU-Hospital Organization, Sweden

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 24, 2020
• Study Start: October 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2025
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)