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

Bispebjerg Hospital

Status: Enrolling

Conditions: Urological Cancer; Life Style; Surgery; Risk Reduction

Treatments: Behavioral: Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04088968

STRONG Cancer Surg (COMPAS)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Prehabilitation

Experimental group

Description:

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.

Treatment:

Behavioral: Prehabilitation

Treatment as usual

No Intervention group

Description:

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.