STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery (STRONG-CS)

March 21, 2024 updated by: Hanne Tonnesen, Bispebjerg Hospital

STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation Including Smoking, Nutrition, Alcohol and Physical Activity for Risk Reduction in Cancer Surgery

Despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (SNAP), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. The intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. The aim of this study is to evaluate the efficacy of intensive SNAP interventions compared to treatment as usual (TAU) in ptt undergoing urological cancer surgery on surgical risk reduction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 SNAP factor:

I. Efficacy and preferences of intensive SNAP-Interventions among patients with at least one SNAP factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. A randomised controlled trial with nested interviews (42 patients).

II. Implementation and preferences of intensive SNAP-Interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. An implementation feasibility study including interviews (20 patients).

III. Reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with Trans-Urethral Resection of the Bladder (TUR-B). A randomised controlled trial with nested interviews (38 patients).

The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.

Study Type

Interventional

Enrollment (Estimated)

100

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

Study Locations

  • Denmark
    • Region H
      • Copenhagen, Region H, Denmark, 2100
        • Recruiting
        • Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet
        • Contact:

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients > 18 years scheduled for cystectomy due to bladder cancer
  • Referral to neoadjuvant chemotherapy
  • Screened positive for minimum 1 SNAP factor
  • Signed informed consent

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • Allergy to pharmaceutical support (Nicotine Replacement Therapy, Disulfiram)
  • Contraindications to exercise.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation
Intervention: Patients allocated to the intervention group receive weekly counselling sessions in 6 weeks as an integrated prehabilitation program tailored to meet the individual patient's need for risk reduction at surgery. It is introduced via the surgical 'Engage in the process of change'. The smoking and alcohol cessation intervention follows the Gold Standard Programme and patients in the intervention group are introduced to a standardized exercise training programme taking individualized needs into account. Nutritional support is also individualized.
Behavioral: Prehabilitation
Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.
Other Names:
  • smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity
No Intervention: Treatment as usual
Treatment as ususal covers shorter interventions, e.g. advice, brief counselling, and handing out the national folders on smoking and alcohol and surgery. Patients are ensured that they are free to access support to lifestyle changes in the community.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with risk reduction at surgery
Time Frame: End of intervention/ at surgery
Corresponding at least 1 step for 1 or more risky lifestyles (but only smoking in study III) on the ASA-score (American Society of Anaesthesiologists physical status classification from 1-5, lower is better)
End of intervention/ at surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life (HRQoL)
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems)
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with any postoperative complication
Time Frame: 30 days
Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death)
30 days
Number of successful tobacco quitters
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

Successful quitting smoking: Study I+ II+ III

  • Successful quitting alcohol intake at 6 weeks and below risky limits at 6 months: Study I.
  • Physical activity at least 30 minutes per day: Study I.
  • Malnutrition: Not at risk of malnutrition: Study I. Obesity: 5% -10 % loss of body fat mass and below 1% gain of body fat mass at 6 months (without developing malnutrition)
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of successful alcohol quitters
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Successful quitting alcohol: Study I+II
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients being physical active at least 30 min per day
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Minutes physical active measured by an accelerometer (longer time is better) : Study I+II
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients not at risk of malnutrition
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
NRS2002 (Nutritional Risk Screening 2002) score>2. Lower is better: Study I+II
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients not at risk of obesity
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
BMI (Body Mass Index)<30. Lower is better : Study I+II
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with improved frailty level
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Measured by Lammers definition: Lower is better: Study I+II+III
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Number of patients with any reduction in lifestyle
Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Measured by yes/no. Study I+II+III
6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

Collaborators and Investigators

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

Sponsor

Bispebjerg Hospital

Collaborators

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Hanne Tonnesen, Professor MD, WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2022

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 8, 2019

First Submitted That Met QC Criteria

September 12, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STRONG Cancer Surg (COMPAS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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