Dataset Information

Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial).

ABSTRACT:

Background

The incidence of colorectal cancer (CRC) increases with age. Older patients are a heterogeneous group ranging from fit to frail with various comorbidities. Frail older patients with CRC are at increased risk of negative outcomes and functional decline after cancer surgery compared to younger and fit older patients. Maintenance of independence after treatment is rarely investigated in clinical trials despite older patients value it as high as survival. Comprehensive geriatric assessment (CGA) is an evaluation of an older persons' medical, psychosocial, and functional capabilities to develop an overall plan for treatment and follow-up. The beneficial effect of CGA is well documented in the fields of medicine and orthopaedic surgery, but evidence is lacking in cancer surgery. We aim to investigate the effect of CGA on physical performance in older frail patients undergoing surgery for CRC.

Methods

GEPOC is a single centre randomised controlled trial including older patients (?65?years) undergoing surgical resection for primary CRC. Frail patients (?14/17 points using the G8 screening tool) will be randomised 1:1 to geriatric intervention and exercise (n =?50) or standard of care along (n =?50) with their standard surgical procedure. Intervention includes preoperative CGA, perioperative geriatric in-ward review and postoperative follow-up. All patients in the intervention group will participate in a pre- and postoperative resistance exercise programme (twice/week, 2?+?12?weeks). Primary endpoint is change in 30-s chair stand test. Assessment of primary endpoint will be performed by physiotherapists blinded to patient allocation. Secondary endpoints: changes in health related quality of life, physical strength and capacity (handgrip strength, gait speed and 6 min walking test), patient perceived quality of recovery, complications to surgery, body composition (Dual-energy X-ray absorptiometry and bioelectric impedance), serum biomarkers, readmission, length of stay and survival.

Discussion

This ongoing trial will provide valuable knowledge on whether preoperative CGA and postoperative geriatric follow-up and intervention including an exercise program can counteract physical decline and improve quality of life in frail CRC patients undergoing surgery.

Trial registration

Prospectively registered at Clinicaltrials.gov NCT03719573 (October 2018).

SUBMITTER: Dolin TG

PROVIDER: S-EPMC7847583 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial).

Dolin Troels G TG Mikkelsen Marta M Jakobsen Henrik L HL Nordentoft Tyge T Pedersen Trine S TS Vinther Anders A Zerahn Bo B Vistisen Kirsten K KK Suetta Charlotte C Nielsen Dorte D Johansen Julia S JS Lund Cecilia M CM

BMC geriatrics 20210130 1

<h4>Background</h4>The incidence of colorectal cancer (CRC) increases with age. Older patients are a heterogeneous group ranging from fit to frail with various comorbidities. Frail older patients with CRC are at increased risk of negative outcomes and functional decline after cancer surgery compared to younger and fit older patients. Maintenance of independence after treatment is rarely investigated in clinical trials despite older patients value it as high as survival. Comprehensive geriatric a ...[more]

PMID: 33516195

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Project description:BackgroundComprehensive geriatric assessment provided in hospital wards in frail patients admitted to hospital has been shown to reduce mortality and increase the likelihood of living at home later. Systematic geriatric assessment provided in emergency departments (ED) may be effective for reducing days in hospital and unnecessary hospital admissions, but this has not yet been proven in randomised trials.MethodsWe conducted a single-centre, randomised controlled trial with a parallel-group, superiority design in an academic hospital ED. ED patients aged ≥ 75 years who were frail, or at risk of frailty, as defined by the Clinical Frailty Scale, were included in the trial. Patients were recruited during the period between December 11, 2018 and June 7, 2019, and followed up for 365 days. For the intervention group, systematic geriatric assessment was added to their standard care in the ED, whereas the control group received standard care only. The primary outcome was cumulative hospital stay during 365-day follow-up. The secondary outcomes included: admission rate from the index visit, total hospital admissions, ED-readmissions, proportion of patients living at home at 365 days, 365-day mortality, and fall-related ED-visits.ResultsA total of 432 patients, 63 % female, with median age of 85 years, formed the analytic sample of 213 patients in the intervention group and 219 patients in the control group. Cumulative hospital stay during one-year follow-up as rate per 100 person-years for the intervention and control groups were: 3470 and 3149 days, respectively, with rate ratio of 1.10 (95 % confidence interval, 0.55-2.19, P = .78). Admission rates to hospital wards from the index ED visit for the intervention and control groups were: 62 and 70 %, respectively (P = .10). No significant differences were observed between the groups for any outcomes.ConclusionSystematic geriatric assessment for older adults with frailty in the ED did not reduce hospital stay during one-year follow-up. No statistically significant difference was observed for any secondary outcomes. More coordinated, continuous interventions should be tested for potential benefits in long-term outcomes.Trial registrationThe trial was registered in the ClinicalTrials.gov (registration number and date NCT03751319 23/11/2018).

Project description:BackgroundIn longevity societies, one of the most serious social issues is sarcopenia and/or frailty. Preventing them is important for maintaining independence and quality of life in the older population. This study investigated the effect of a self-monitoring comprehensive geriatric intervention programme (CGIP) on physical function and muscle size in community-dwelling older adults. We compared the effects of a CGIP using weekly class-styled (CS) sessions and a home-based (HB) programme.MethodsThe 526 participants were randomized into one of two groups (CS 251, HB 275) based on their residential districts. We conducted a 12 week CGIP, which consisted of low-load resistance exercise, physical activity increments, oral function improvements, and a nutritional guide. All participants were encouraged to attend two 90 min lectures that included instructions on the CGIP. They were provided with exercise materials (triaxial-accelerometers/pedometers, ankle weights, and elastic bands) and diary logs. The CS group attended 90 min weekly sessions and independently executed the programme on other days, whereas the HB group only received instructions on how to execute the programme. Physical functions, such as knee extension strength (KES), normal and maximum walking speed, the timed up-and-go test, and anterior thigh muscle thickness (MT), were measured and analysed using intention-to-treat analysis before and after the 12 week intervention.ResultsOf the 526 participants identified, 517 (CS 243 age 74.0 ± 5.4 women 57.2%, HB 274 age 74.0 ± 5.6 women 58.8%) were enrolled. Nine (CS 8, HB 1) were excluded from the analysis because they did not participate in the pre-intervention measurements. Both interventions significantly improved KES (CS 18.5%, HB 10.6%), normal walking speed (CS 3.7%, HB 2.8%), and MT (CS 3.2%, HB 3.5%). Greater improvement of KES was observed in the CS group (P = 0.003). Maximum walking speed (CS 4.7%, HB 1.8%; P = 0.001) and timed up-and-go (CS -4.7%, HB -0.2%; P < 0.001) significantly improved in the CS group only.ConclusionsThe intervention was effective in preventing sarcopenia and/or frailty. Most physical functions and MT improved after both interventions. The HB intervention is cost-effective and may help prevent sarcopenia and/or frailty in the large older population.

Project description:BACKGROUND: The study determined the one year incidence of post operative cognitive decline (POCD) and evaluated the effectiveness of an intra-operative anaesthetic intervention in reducing post-operative cognitive impairment in older adults (over 60 years of age) undergoing elective orthopaedic or abdominal surgery. METHODS AND TRIAL DESIGN: The design was a prospective cohort study with a nested randomised, controlled intervention trial, using intra-operative BiSpectral index and cerebral oxygen saturation monitoring to enable optimisation of anaesthesia depth and cerebral oxygen saturation in older adults undergoing surgery. RESULTS: In the 52 week prospective cohort study (192 surgical patients and 138 controls), mild (?(2) = 17.9 p<0.0001), moderate (?(2) = 7.8 p = 0.005) and severe (?(2) = 5.1 p = 0.02) POCD were all significantly higher after 52 weeks in the surgical patients than among the age matched controls. In the nested RCT, 81 patients were randomized, 73 contributing to the data analysis (34 intervention, 39 control). In the intervention group mild POCD was significantly reduced at 1, 12 and 52 weeks (Fisher's Exact Test p = 0.018, ?(2) = 5.1 p = 0.02 and ?(2) = 5.9 p = 0.015), and moderate POCD was reduced at 1 and 52 weeks (?(2) = 4.4 p = 0·037 and ?(2) = 5.4 p = 0.02). In addition there was significant improvement in reaction time at all time-points (Vigilance Reaction Time MWU Z = -2.1 p = 0.03, MWU Z = -2.7 p = 0.004, MWU Z = -3.0 p = 0.005), in MMSE at one and 52 weeks (MWU Z = -2.9 p = 0.003, MWU Z = -3.3 p = 0.001), and in executive function at 12 and 52 weeks (Trail Making MWU Z = -2.4 p = .0.018, MWU Z = -2.4 p = 0.019). CONCLUSION: POCD is common and persistent in older adults following surgery. The results of the nested RCT indicate the potential benefits of intra-operative monitoring of anaesthetic depth and cerebral oxygenation as a pragmatic intervention to reduce post-operative cognitive impairment. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN39503939.

Project description:ObjectiveTo evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.Search strategyWe searched the EPOC Register, Cochrane's Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.Selection criteriaRandomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designated wards) compared with usual care. Comprehensive geriatric assessment is a multidimensional interdisciplinary diagnostic process used to determine the medical, psychological, and functional capabilities of a frail elderly person to develop a coordinated and integrated plan for treatment and long term follow-up.Data collection and analysisThree independent reviewers assessed eligibility and trial quality and extracted published data. Two additional reviewers moderated.ResultsTwenty two trials evaluating 10,315 participants in six countries were identified. For the primary outcome "living at home," patients who underwent comprehensive geriatric assessment were more likely to be alive and in their own homes at the end of scheduled follow-up (odds ratio 1.16 (95% confidence interval 1.05 to 1.28; P = 0.003; number needed to treat 33) at a median follow-up of 12 months versus 1.25 (1.11 to 1.42; P < 0.001; number needed to treat 17) at a median follow-up of six months) compared with patients who received general medical care. In addition, patients were less likely to be living in residential care (0.78, 0.69 to 0.88; P < 0.001). Subgroup interaction suggested differences between the subgroups "wards" and "teams" in favour of wards. Patients were also less likely to die or experience deterioration (0.76, 0.64 to 0.90; P = 0.001) and were more likely to experience improved cognition (standardised mean difference 0.08, 0.01 to 0.15; P = 0.02) in the comprehensive geriatric assessment group.ConclusionsComprehensive geriatric assessment increases patients' likelihood of being alive and in their own homes after an emergency admission to hospital. This seems to be especially true for trials of wards designated for comprehensive geriatric assessment and is associated with a potential cost reduction compared with general medical care.

Dataset Information

Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial).

Background

Methods

Discussion

Trial registration

Publications

Geriatric assessment and intervention in older vulnerable patients undergoing surgery for colorectal cancer: a protocol for a randomised controlled trial (GEPOC trial).

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