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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in the control group are scheduled for surgery in compliance with the Danish cancer patient pathway guarantees (within 14 days). | |
| Intervention with Pre-KiT prehabilitation | Experimental | Participants in the intervention group are scheduled for surgery after four weeks of Pre-KiT prehabilitation. The prehabilitation consists of a geriatric guided assessment with relevant targeted interventions, a home exercise program and assisted smoking cessation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Other | Pre-KiT prehabilitation consists of
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to outpatient follow-up at 21 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Multiple times from enrollment to outpatient follow-up at 90 days after surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marie M Haslund, MD | Contact | 004538682699 | marie.mykloey.haslund@regionh.dk | |
| Professor Fode, MD, PhD, FEBU, FECSM | Contact | 004538682093 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Herlev and Gentofte Hospital | Recruiting | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41592385 | Derived | Juul-Haslund M, Lund CM, Dolin TG, Schou-Jensen K, Ostergren PB, Vinther A, Thomsen FF, Fode M. Geriatric prehabilitation prior to surgery for kidney tumors: Study protocol for Pre-KiT - A randomized controlled trial. J Geriatr Oncol. 2026 Mar;17(2):102893. doi: 10.1016/j.jgo.2026.102893. Epub 2026 Jan 26. |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| D015577 | Geriatric Assessment |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From enrollment to 1 year follow-up |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009043 |
| Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |