Prehabilitation Prior to Surgery for Kidney Tumors

NCT06745609 | Recruiting

• 1 other identifier: H-24066449
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

• 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?

Conditions

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

Keywords

Prehabilitation; Quality of life; Kidney tumor; Renal cell tumor; Renal cell cancer; Kidney cancer; Quality of recovery; Elderly

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (10)

• Change in Quality of Recovery at other times

  Multiple times from enrollment to outpatient follow-up at 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.

• Change in hand grip strength

  Multiple times from enrollment to outpatient follow-up at 90 days after surgery.

• Compliance to the prehabilitation program

  From enrollment to the preoperative assessment

• Days alive and out of hospital 90 days

  From hospital discharge to follow-up 90 days after surgery.

Study Arms (2)

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.

Other: Prehabilitation

Interventions

Prehabilitation 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

Also known as: Geriatric assessment, Physical activity, Smoking cessation

Intervention with Pre-KiT prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead

Study Sites (1)

Department of Urology, Herlev and Gentofte Hospital

Herlev, 2730, Denmark

RECRUITING

Related Publications (1)

• 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 Jan 26;17(2):102893. doi: 10.1016/j.jgo.2026.102893. Online ahead of print.

  PMID: 41592385 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Preoperative Exercise; Geriatric Assessment; Exercise

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Marie M Haslund, MD

CONTACT

004538682699; marie.mykloey.haslund@regionh.dk

Professor Fode, MD, PhD, FEBU, FECSM

CONTACT

004538682093

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD-student

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 20, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2032
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)