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

NCT ID: NCT04097795

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Colorectal Cancer Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Prehabilitation

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leading the Change: Collaboration of health Insurers in the Netherlands

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marcel G Olde Rikkert, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Geriatric Medicine, RadboudUmC

Locations

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Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status

Radboudumc

Nijmegen, , Netherlands

Site Status

Streekziekenhuis Koningin Beatrix

Winterswijk, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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PreColo CU

Identifier Type: -

Identifier Source: org_study_id