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

Terminated

• Conditions: Colorectal Cancer; Surgery
• Interventions: Other: Prehabilitation

• Registration Number: NCT04097795
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Status Verified: 2021-03
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prehabilitation	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.

Primary Outcome Measures

Name	Time	Method
EQ-5D-5L	0-6 months	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'.
Costs	0-6 months	From a societal perspective including health care consumption costs, patient out-of-pocket costs, and productivity losses of informal caregivers

Secondary Outcome Measures

Name	Time	Method
Number of deceased patients	0-6 months	Data on mortality will be assessed based on medical records.
Morbidity	0-6 months	Number and severity of complications will be assed based on medical records.
(I)ADL dependence by TOPICS-SF	0-6 months	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.
(I)ADL dependence by GARS	0-6 months	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.
Return to normal activity	0-6 months	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.
Care-related burden among informal caregivers	0-6 months	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.

Trial Locations

Locations (5)

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Netherlands

Noordwest Ziekenhuisgroep; 🇳🇱 Alkmaar, Netherlands

Radboudumc; 🇳🇱 Nijmegen, Netherlands

Streekziekenhuis Koningin Beatrix; 🇳🇱 Winterswijk, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Netherlands