A randomised controlled trial of geriatric liaison intervention in frail surgical oncology patients
| ISRCTN | ISRCTN46161863 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46161863 |
| Secondary identifying numbers | NL810, NTR823 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 05/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr B L van Leeuwen
Scientific
Scientific
University Medical Center Groningen (UMCG)
Department of Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands
| Phone | +31 (0)50 361 2301 |
|---|---|
| blvleeuwen@hetnet |
Study information
| Study design | Randomised, controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | A randomised controlled trial of geriatric liaison intervention in frail surgical oncology patients |
| Study objectives | The primary objective of this study is to show that early detection of geriatric patients at risk of preventable functional decline following a surgical procedure under general anesthesia for a solid tumor, combined with a geriatric liaison intervention will decrease the occurrence of delirium and consequent morbidity and mortality, without an increase in costs. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Frail surgical oncology geriatric patients |
| Intervention | The intervention entails participation of a geriatric nurse and geriatrician in the perioperative treatment of the oncogeriatric surgical patient. Multi-component interventions to achieve best-supportive care in individual treatment plans will be implemented. These will be focused on electrolyte- and fluid levels, pain management, pharmacological clearance, miction and defecation, nutrition, early mobilisation and rehabilitation, sleep, vision, hearing and cognition. The Delirium Observation Scale (DOS) will be used to screen for delirium by the nurse and the Delirium Rating Scale (DRS) will be used to measure the severity of the delirium. To ensure uniformity of geriatric intervention in participating centres a daily checklist will be used. |
| Intervention type | Other |
| Primary outcome measure | The cumulative incidence of delirium (measured with the Delirium Observation Scale and the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM IV] criteria) up to ten days postoperatively. |
| Secondary outcome measures | 1. Returning to the pre-operative living situation within 3 months postoperatively 2. The Physical Component Summary measure (PCS) of the Short Form health survey (SF-36) 3. The Mental Component Summary measure (MCS) of the SF-36 4. Complications during hospital stay including mortality 5. Care Dependence Scale at discharge 6. Direct health care and non-health care costs will be used as economic indicators |
| Overall study start date | 01/01/2007 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 294 |
| Total final enrolment | 260 |
| Key inclusion criteria | 1. A score greater than three on the Groningen Frailty Index (GFI) 2. Surgery is scheduled more than 24 hours after inclusion in the study as we feel this is the time necessary for the geriatric team to plan their perioperative measures 3. Surgery under general anesthesia 4. Written informed consent given according to local regulations |
| Key exclusion criteria | 1. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 2. Patient unable to comply with the outcome questionnaires |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 01/01/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 30.001
Groningen
9700 RB
Netherlands
| Website | http://www.rug.nl/umcg/index?lang=en |
|---|---|
"ROR" |
https://ror.org/03cv38k47 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 22/02/2016 | 05/01/2021 | Yes | No |
Editorial Notes
05/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR number has been added
