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

Surgery Clinical Trial

— STRONG-CS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04088968
• Other study ID #: STRONG Cancer Surg (COMPAS)
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Bispebjerg Hospital
• Contact: Hanne Tønnesen, Professor MD
• Phone: +4538163840
• Email: hanne.tonnesen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Life Style
• Risk Reduction
• Surgery
• Urologic Neoplasms
• Urological Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet	Copenhagen	Region H

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with risk reduction 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	Health related quality of life (HRQoL)	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
Secondary	Number of patients with any postoperative complication	Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death)	30 days
Secondary	Number of successful tobacco quitters	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
Secondary	Number of successful alcohol quitters	Successful quitting alcohol: Study I+II	6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Secondary	Number of patients being physical active at least 30 min per day	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
Secondary	Number of patients not at risk of malnutrition	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
Secondary	Number of patients not at risk of obesity	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
Secondary	Number of patients with improved frailty level	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
Secondary	Number of patients with any reduction in lifestyle	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