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

NCT04088968 | Recruiting DMC

• 1 other identifier: STRONG Cancer Surg (COMPAS)
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Reduction; Urological Cancer; Surgery; Life Style

Keywords

Postoperative complications; Prehabilitation; Surgical risk reduction; Smoking; Alcohol drinking; Physical activity; Malnutrition; Obesity; Patient preferences; Randomised controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Health related quality of life (HRQoL)

  6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

• Number of patients with any postoperative complication

  30 days

• Number of successful tobacco quitters

  6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

• Number of successful alcohol quitters

  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

  6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months

Study Arms (2)

Prehabilitation

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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.

Interventions

Prehabilitation BEHAVIORAL

Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.

Also known as: smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity

Prehabilitation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Region H, 2100, Denmark

RECRUITING

Related Publications (1)

• Tonnesen H, Lydom LN, Joensen UN, Egerod I, Pappot H, Lauridsen SV. STRONG for Surgery & Strong for Life - against all odds: intensive prehabilitation including smoking, nutrition, alcohol and physical activity for risk reduction in cancer surgery - a protocol for an RCT with nested interview study (STRONG-Cancer). Trials. 2022 Apr 21;23(1):333. doi: 10.1186/s13063-022-06272-2.

  PMID: 35449008 DERIVED

MeSH Terms

Conditions

Risk Reduction Behavior; Urologic Neoplasms; Postoperative Complications; Smoking; Alcohol Drinking; Motor Activity; Malnutrition; Obesity; Patient Preference

Interventions

Preoperative Exercise; Ethanol; Exercise; Nutritional Support; Adiposity

Condition Hierarchy (Ancestors)

Behavior; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drinking Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior

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; Alcohols; Organic Chemicals; Nutrition Therapy; Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Hanne Tonnesen, Professor MD

  WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanne Tønnesen, Professor MD

CONTACT

+4538163840; hanne.tonnesen@regionh.dk

Susanne V Lauridsen, PhD

CONTACT

+4535451704; susanne.vahr.lauridsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will not know if patients were allocated to intervention or control group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: September 13, 2019
• Study Start: January 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

DK (1)