Prehabilitation Prior to Surgery for Kidney Tumors

Not Applicable

Recruiting

• Conditions: Renal Cancer; Renal Cell Cancer; Kidney Cancers; Stage I Renal Cell Cancer; Prehabilitation; Elderly (people Aged 65 or More)

• Registration Number: NCT06745609
• Lead Sponsor: Herlev and Gentofte Hospital

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Status Verified: 2025-01
• Study Start: 2025-01-21
• Last Update Submitted: 2025-01-22
• Last Update Posted: 2025-01-24
• Primary Completion: 2027-03
• Study Completion: 2032-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 65 years or older
• cT1 kidney tumor, scheduled for either partial or radical nephrectomy.
• Clinical Frailty Scale 3-6

Exclusion Criteria

• It is determined by an attending physician, or at a multi-disciplinary team-conference, that a 2-4 week postponement of surgery will not be beneficial for the participant.
• Participant does not understand Danish og English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in quality of recovery from screening to outpatient follow-up 21 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Recovery at other times	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.
Change in the 30 second chair stand test	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.
Change in hand grip strength	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.
Compliance to the prehabilitation program	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.
Days alive and out of hospital 90 days	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.
Change in Quality of Life	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.
Medical and surgical complications defined according to Clavien-Dindo at 30 and 90 days after surgery	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.
Health economic analysis	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.
Survival	From surgery to 5 year follow-up.	Recurrence-free survival, Cause-specific survival and overall survival measured at 1 and 5 years after surgery.
Change in muscle mass	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.

Trial Locations

Locations (1)

Department of Urology, Herlev and Gentofte Hospital; 🇩🇰 Herlev, Denmark