The goal of this clinical trial is to examine if one month of general health optimization before surgery for kidney tumors can help participants recover more quickly from surgery. The optimization process is called prehabiliation, and will last one month. It consists of 1. A comprehensive health assessment 2. Assisted smoking cessation 3. A home exercise program. The investigators will compare an intervention group receiving one month of prehabilitation with a control group receiving the standard of care. Some of the main questions the investigators want to answer are * Are participants in the intervention group more satisfied with their quality of recovery after surgery? * Do participants in the intervention group maintain more of their physical abilites compared to the control group?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Pre-KiT prehabilitation consists of 1. A geriatric guided assessment with relevant interventions. The assessment will include cognitive evaluation, screening for depression, functional assessment, as well as evaluation of nutritional risk, assessment of past and current diseases, and a thorough review of the patient's medication list focusing on drug interactions. It will also include social history and standard laboratory results, 2. Physical activity. A four week home exercise program, adjusted to the participants physical abilities. 3. Assisted smoking cessation
Department of Urology, Herlev and Gentofte Hospital
Herlev, Denmark
Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
Quality of recovery is evaluated with the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at enrollment, preoperatively, and 1, 21 and 90 days after surgery. Change in QoR-15 from enrollment to 21 days after surgery is the primary outcome measure. Change in QoR-15 at other assessment times will be assessed as secondary outcome measures.
Time frame: From enrollment to outpatient follow-up at 21 days after surgery.
Change in Quality of Recovery at other times
Quality of recovery is measured by the danish translation of the verified questionnaire Quality of Recovery-15. It is a 15-item patient questionnaire, where the score ranges from 0-150. A higher score indicates better patient-reported quality of recovery. QoR-15 will be assessed at enrollment, preoperatively, and 1, 21 and 90 days after surgery.
Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in the 30 second chair stand test
Physical ability is measured by the 30 second chair stand test. The test is performed at enrollment, preoperatively, 21 and 90 days after surgery.
Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in hand grip strength
Physical ability is measured by hand grip strength. The test is performed with a hand-dynamometer at enrollment, preoperatively, 21 and 90 days after surgery.
Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Compliance to the prehabilitation program
Compliance to the prehabilitation program is measured by brief phone interviews with the study participants in the intervention group two times a week during the intervention.
Time frame: From enrollment to the preoperative assessment
Days alive and out of hospital 90 days
Days alive and out of hospital (DAOH) is the number of days not in hospital after surgery. DAOH will be calculated at 90 days after surgery.
Time frame: From hospital discharge to follow-up 90 days after surgery.
Change in Quality of Life
Quality of life is evaluated with the danish translation of the validated questionnaire EQ-5D-5L. The questionnaire evalutes five health dimensions (mobility, self-care, usual acitivites, pain/discomfort, anxiety/depression) ranging from "no problems" to "unable/ extreme problems". Additionally, it includes a visual analog scale scoring from 0-100, reflecting the participants overall self-reported health state. A higher score indicates a better patient-reported quality of life. Quality of life will be assessed at enrollment, preoperatively, 21 and 90 days after surgery.
Time frame: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery
Clavien-Dindo is a system to summarize and classify postoperative complications. Complications will be identified in participants records, and scored according to the Clavien-Dindo grades I-V, where V is the most severe. Registration of complications will be conducted at 30 and 90 days after surgery.
Time frame: At 30 and 90 days after surgery.
Health economic analysis
Health-related expenses associated with standard treatment and PreKiT-based treatment will be analyzed and compared across the two study arms.
Time frame: From enrollment to 1 year follow-up
Survival
Recurrence-free survival, Cause-specific survival and overall survival measured at 1 and 5 years after surgery.
Time frame: From surgery to 5 year follow-up.
Change in muscle mass
Change in muscle mass, comparing measures on preoperative-CT and one year follow-up CT, including assessment of sarcopenia according to current European guidelines.
Time frame: From enrollment to 1 year follow-up
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