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

NCT ID: NCT04088968

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Risk Reduction; Urological Cancer; Surgery; Life Style

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Prehabilitation

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hanne Tonnesen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hanne Tonnesen, Professor MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet

Copenhagen, Region H, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Hanne Tønnesen, Professor MD

Role: CONTACT

hanne.tonnesen@regionh.dk

+4538163840

Susanne V Lauridsen, PhD

Role: CONTACT

susanne.vahr.lauridsen@regionh.dk

+4535451704

Facility Contacts

Susanne V Lauridsen, PhD

Role: primary

susanne.vahr.lauridsen@regionh.dk

+4535451704

References

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.

Reference Type: DERIVED

PMID: 35449008 (View on PubMed)

Other Identifiers

STRONG Cancer Surg (COMPAS)

Identifier Type: -

Identifier Source: org_study_id