Department of Urology, Herlev and Gentofte Hospital
Herlev, 2730, Denmark
Location status: Recruiting
Location contact
Marie M Haslund, MD
CONTACT
Marie M Haslund, MD
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT06745609
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?
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Not applicable
Herlev, 2730, Denmark
Location status: Recruiting
Marie M Haslund, MD
CONTACT
Marie M Haslund, MD
PRINCIPAL_INVESTIGATOR
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pre-KiT prehabilitation consists of
Other names: Geriatric assessment, Physical activity, Smoking cessation
Time frame: From enrollment to outpatient follow-up at 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: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
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.
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.
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: From enrollment to the preoperative assessment
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 hospital discharge to follow-up 90 days after surgery.
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: Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
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: 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: From enrollment to 1 year follow-up
Health-related expenses associated with standard treatment and PreKiT-based treatment will be analyzed and compared across the two study arms.
Time frame: From surgery to 5 year follow-up.
Recurrence-free survival, Cause-specific survival and overall survival measured at 1 and 5 years after surgery.
Time frame: From enrollment to 1 year follow-up
Change in muscle mass, comparing measures on preoperative-CT and one year follow-up CT, including assessment of sarcopenia according to current European guidelines.
Contact information is provided by the study sponsor or research team.
Marie M Haslund, MD
CONTACT
Professor Fode, MD, PhD, FEBU, FECSM
CONTACT
Herlev and Gentofte Hospital
Other
Prehabilitation Prior to Surgery for Kidney Tumors: A Randomized Controlled Research Study (Pre-KiT)
Acronym: Pre-KiT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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