Prehabilitation Prior to Surgery for Kidney Tumors

NCT ID: NCT06745609

Last Updated: 2025-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-21

Study Completion Date

2032-03-31

Brief Summary

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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

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

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Conditions

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Renal Cancer Renal Cell Cancer Kidney Cancers Stage I Renal Cell Cancer Prehabilitation Elderly (People Aged 65 or More)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group

Participants in the control group are scheduled for surgery in compliance with the Danish cancer patient pathway guarantees (within 14 days).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Geriatric assessment Physical activity Smoking cessation

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marie Mykløy Haslund

M.D., PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Urology, Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Marie M Haslund, MD

Role: CONTACT

004538682699

Professor Fode, MD, PhD, FEBU, FECSM

Role: CONTACT

004538682093

Facility Contacts

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Marie M Haslund, MD

Role: primary

004538682699

Role: backup

Other Identifiers

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H-24066449

Identifier Type: -

Identifier Source: org_study_id

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