Incremental Cost-Utility Study on Prehabilitation Among Older Patients With Colorectal Cancer Undergoing Surgery (PreColo CU)

Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients

A prospective multicenter observational cost-utility study following older or high-risk patients with colorectal cancer with and without prehabilitation before surgery.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Surgery
• Intervention / Treatment: Other: Prehabilitation

Detailed Description

This study will answer the question whether prehabilitation is cost-effective in colorectal cancer surgery among individual patients aged 70 years and above or patients with an American Society of Anesthesiologists (ASA) score of III. We also aim to identify factors facilitating or impairing implementation of prehabilitation such that it is cost-effective.

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Netherlands
  • Alkmaar, Netherlands
    • Noordwest Ziekenhuisgroep
  • Almelo, Netherlands
    • Ziekenhuisgroep Twente
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Nijmegen, Netherlands
    • Radboudumc
  • Winterswijk, Netherlands
    • Streekziekenhuis Koningin Beatrix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 70 years and above or patients with an ASA III score who are diagnosed with colorectal cancer and are scheduled for surgery as primary intervention will be recruited in the outpatient clinic of the surgery department of the participating hospitals.

Description

Inclusion Criteria:

• Age ≥ 70 years or American Society of Anesthesiologists (ASA) score of III
• Scheduled for colorectal cancer surgery

Exclusion Criteria:

• Metastatic disease known preoperatively
• ASA IV score or higher
• Paralytic or immobilized patients (not capable to perform exercise)
• Prior use of neoadjuvant therapy for the same indication
• Not able or willing to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prehabilitation; Patients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which offer prehabilitation.	Other: Prehabilitation; According to our definition, prehabilitation consists of exercise therapy during at least 2 weeks. This is combined with optimalisation of the patients' nutritional status at least 2 weeks before surgery.
No prehabilitation; Patients aged 70 years and above or with an American Society of Anesthesiologists (ASA) score of III, who are scheduled for colorectal cancer surgery in one of the participating hospitals which do not offer prehabilitation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D-5L	Quality of life according to the EuroQol-5 dimensions-5 levels questionnaire. The 5 dimensions cover mobility, selfcare, daily activities, pain/discomfort and anxiety. All dimensions are rated on a 5 level scale ranging from 'I have no problems with ....(dimension)' to 'I am not able to/I am extremely...(dimension)'. The first option is considered 'better' and the latter as 'worse'.	0-6 months
Costs	From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deceased patients	Data on mortality will be assessed based on medical records.	0-6 months
Morbidity	Number and severity of complications will be assed based on medical records.	0-6 months
(I)ADL dependence by GARS	Dependence regarding (instrumental) acitivities of daily living ((I)ADL)according to the Gait Assessment Rating Scale (GARS). Several items with regard to self-reliance are scored according to the phrase 'I can do ....(item) completely independently.......'. Possible answers are 'Without any effort', 'with some effort', 'With a lot of effort', and 'Only with help from others'. The first is considered better and the latter as worse.	0-6 months
(I)ADL dependence by TOPICS-SF	Dependence regarding (instrumental) acitivities of daily living according toThe Older Persons and Informal Caregivers Survey Short form (TOPICS-SF) questionnaire for patients. This questionnaire contains GARS and EQ-5D amongst others and is spread throughout the questionnaire.	0-6 months
Return to normal activity	The return to normal activity (RNA) of patients is investigated by the different questionnaires listed above on several time-points. After surgery, we can examine the time within a time frame of 6 months that patients return to their normal activities.	0-6 months
Care-related burden among informal caregivers	The Older Persons and Informal Caregivers Survey Minimum Dataset (TOPICS-MDS) questionnaire for caregivers in which the domains 'self-reported health' (by RAND-36 health survey), 'quality of life' (by carerQol), 'hours of informal care' (number), and 'perceived burden' (on visual analog scale) are covered.	0-6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Leading the Change: Collaboration of health Insurers in the Netherlands
• Investigators: Principal Investigator: Marcel G Olde Rikkert, MD PhD, Department of Geriatric Medicine, RadboudUmC

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PreColo CU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No