Clinical trial NCT04088968: STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
First posted: 2019-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of patients with risk reduction at surgery
timeFrame: End of intervention/ at surgery
Secondary outcomes:
measure: Health related quality of life (HRQoL)
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients with any postoperative complication
timeFrame: 30 days
measure: Number of successful tobacco quitters
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of successful alcohol quitters
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients being physical active at least 30 min per day
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients not at risk of malnutrition
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients not at risk of obesity
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients with improved frailty level
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
measure: Number of patients with any reduction in lifestyle
timeFrame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet
state: Region H
Study officials:
affiliation: WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
name: Hanne Tonnesen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.