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

NCT04097795 | Terminated

• 1 other identifier: PreColo CU
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Colorectal Cancer; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Number of deceased patients

  0-6 months

• Morbidity

  0-6 months

• (I)ADL dependence by GARS

  0-6 months

• (I)ADL dependence by TOPICS-SF

  0-6 months

• Return to normal activity

  0-6 months

Study Arms (2)

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

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.

Interventions

Prehabilitation 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.

Prehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Leading the Change: Collaboration of health Insurers in the Netherlands: collaborator

Study Sites (5)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

Location

Ziekenhuisgroep Twente

Almelo, Netherlands

Location

Radboudumc

Nijmegen, Netherlands

Location

Streekziekenhuis Koningin Beatrix

Winterswijk, Netherlands

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Marcel G Olde Rikkert, MD PhD

  Department of Geriatric Medicine, RadboudUmC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 20, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: December 18, 2023

Record last verified: 2021-03

Locations

NL (5)