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

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ClinicalTrials.gov Identifier: NCT04097795
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Leading the Change: Collaboration of health Insurers in the Netherlands
Information provided by (Responsible Party):
Radboud University

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

Condition or disease Intervention/treatment
Colorectal Cancer Surgery 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Incremental Cost-utility Study on Prehabilitation for Colon Cancer Surgery in Older Patients
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. EQ-5D-5L [ Time Frame: 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'.

  2. Costs [ Time Frame: 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 :
  1. Number of deceased patients [ Time Frame: 0-6 months ]
    Data on mortality will be assessed based on medical records.

  2. Morbidity [ Time Frame: 0-6 months ]
    Number and severity of complications will be assed based on medical records.

  3. (I)ADL dependence by GARS [ Time Frame: 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.

  4. (I)ADL dependence by TOPICS-SF [ Time Frame: 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.

  5. Return to normal activity [ Time Frame: 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.

  6. Care-related burden among informal caregivers [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097795


Contacts
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Contact: Thea Heil, Msc. +31243614868 thea.heil@radboudumc.nl

Locations
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Netherlands
Ziekenhuisgroep Twente Recruiting
Almelo, Netherlands
Contact: D.J. Evers         
Jeroen Bosch Ziekenhuis Recruiting
Den Bosch, Netherlands
Contact: E. Verdaasdonk         
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: T.C. Zonneveld-Heil         
Sponsors and Collaborators
Radboud University
Leading the Change: Collaboration of health Insurers in the Netherlands
Investigators
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Principal Investigator: Marcel G Olde Rikkert, MD PhD Department of Geriatric Medicine, RadboudUmC

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT04097795     History of Changes
Other Study ID Numbers: PreColo CU
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases