STRONG for Surgery & Strong for Life - Against All Odds: Intensive Prehabilitation for Risk Reduction in Cancer Surgery (STRONG-CS)
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|ClinicalTrials.gov Identifier: NCT04088968|
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : April 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Risk Reduction Urological Cancer Surgery Life Style||Behavioral: Prehabilitation||Not Applicable|
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 (38 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 (20 patients).
The intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. The control groups receive standard care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised Controlled Trials, Implementation feasibilty trial, Interviews nested|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessors will not know if patients were allocated to intervention or control group|
|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|
|Actual Study Start Date :||January 1, 2022|
|Estimated Primary Completion Date :||June 30, 2024|
|Estimated Study Completion Date :||December 31, 2024|
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.
Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.
Other Name: smoking cessation, alcohol cessation, physical activity, nutritional support for malnutrition and obesity
No 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.
- Number of patients with risk reduction at surgery [ Time Frame: End of intervention/ 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)
- Health related quality of life (HRQoL) [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]Mean difference of HRQoL between groups measured with EQ5D (5 level quality of life score (level 1 =no problems, level 2-5 =problems)
- Number of patients with any postoperative complication [ Time Frame: 30 days ]Scored by the Comprehensive Complication Index, a linear scale ranging from 0 (no complication) to 100 (death)
- Number of successful tobacco quitters [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]
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)
- Number of successful alcohol quitters [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]Successful quitting alcohol: Study I+II
- Number of patients being physical active at least 30 min per day [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]Minutes physical active measured by an accelerometer (longer time is better) : Study I+II
- Number of patients not at risk of malnutrition [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]NRS2002 (Nutritional Risk Screening 2002) score>2. Lower is better: Study I+II
- Number of patients not at risk of obesity [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]BMI (Body Mass Index)<30. Lower is better : Study I+II
- Number of patients with improved frailty level [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]Measured by Lammers definition: Lower is better: Study I+II+III
- Number of patients with any reduction in lifestyle [ Time Frame: 6 weeks/day at surgery, at 1 month and through study completion, an average of 6 months ]Measured by yes/no. Study I+II+III
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088968
|Contact: Hanne Tønnesen, Professor MDemail@example.com|
|Contact: Susanne V Lauridsen, PhDfirstname.lastname@example.org|
|Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet||Recruiting|
|Copenhagen, Region H, Denmark, 2100|
|Contact: Susanne V Lauridsen, PhD +4535451704 email@example.com|
|Principal Investigator:||Hanne Tonnesen, Professor MD||WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen|