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
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Surgery||Other: Prehabilitation|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|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|
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.
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.
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.
- 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'.
- 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
- Number of deceased patients [ Time Frame: 0-6 months ]Data on mortality will be assessed based on medical records.
- Morbidity [ Time Frame: 0-6 months ]Number and severity of complications will be assed based on medical records.
- (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.
- (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.
- 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.
- 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.
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
|Contact: Thea Heil, Msc.||+firstname.lastname@example.org|
|Contact: D.J. Evers|
|Jeroen Bosch Ziekenhuis||Recruiting|
|Den Bosch, Netherlands|
|Contact: E. Verdaasdonk|
|Contact: T.C. Zonneveld-Heil|
|Principal Investigator:||Marcel G Olde Rikkert, MD PhD||Department of Geriatric Medicine, RadboudUmC|