Prehabilitation Prior to Surgery for Kidney Tumors (Pre-KiT)

January 22, 2025 updated by: Marie Mykløy Haslund, Herlev and Gentofte Hospital

Prehabilitation Prior to Surgery for Kidney Tumors: a Randomized Controlled Research Study (Pre-KiT)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Professor Fode, MD, PhD, FEBU, FECSM
  • Phone Number: 004538682093

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Participants in the control group are scheduled for surgery in compliance with the Danish cancer patient pathway guarantees (within 14 days).
Experimental: Intervention with Pre-KiT prehabilitation
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.
Other: Prehabilitation

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
Other Names:
  • Physical activity
  • Smoking cessation
  • Geriatric assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of recovery from screening to outpatient follow-up 21 days after surgery
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.
From enrollment to outpatient follow-up at 21 days after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Recovery at other times
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.
Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in the 30 second chair stand test
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.
Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Change in hand grip strength
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.
Multiple times from enrollment to outpatient follow-up at 90 days after surgery.
Compliance to the prehabilitation program
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.
From enrollment to the preoperative assessment
Days alive and out of hospital 90 days
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.
From hospital discharge to follow-up 90 days after surgery.
Change in Quality of Life
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.
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
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.
At 30 and 90 days after surgery.
Health economic analysis
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.
From enrollment to 1 year follow-up
Survival
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.
From surgery to 5 year follow-up.
Change in muscle mass
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.
From enrollment to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev and Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2032

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-24066449

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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