Incremental Cost-Utility Study on Prehabilitation Among Older Patients With Colorectal Cancer Undergoing Surgery

Colorectal Cancer Clinical Trial

— PreColo CU  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04097795
• Other study ID #: PreColo CU
• Status: Terminated
• Start date: July 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Ziekenhuisgroep Twente	Almelo
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch
Netherlands	Radboudumc	Nijmegen
Netherlands	Streekziekenhuis Koningin Beatrix	Winterswijk

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Leading the Change: Collaboration of health Insurers in the Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of deceased patients	Data on mortality will be assessed based on medical records.	0-6 months
Secondary	Morbidity	Number and severity of complications will be assed based on medical records.	0-6 months
Secondary	(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
Secondary	(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
Secondary	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
Secondary	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