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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088968
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : April 21, 2022
Sponsor:
Collaborator:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Hanne Tonnesen, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Risk Reduction Urological Cancer Surgery Life Style Behavioral: Prehabilitation Not Applicable

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 (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.
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.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Hanne Tønnesen, Professor MD +4538163840 hanne.tonnesen@regionh.dk
Contact: Susanne V Lauridsen, PhD +4535451704 susanne.vahr.lauridsen@regionh.dk

Locations
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Denmark
Dept Urology 2112, Copenhagen University Hospital, Rigshospitalet Recruiting
Copenhagen, Region H, Denmark, 2100
Contact: Susanne V Lauridsen, PhD    +4535451704    susanne.vahr.lauridsen@regionh.dk   
Sponsors and Collaborators
Bispebjerg Hospital
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Hanne Tonnesen, Professor MD WHOCC, The Parker Institute, Bispebjerg-Frederiksberg Hospital, RegH, Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hanne Tonnesen, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT04088968    
Other Study ID Numbers: STRONG Cancer Surg (COMPAS)
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: April 21, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanne Tonnesen, Bispebjerg Hospital:
Postoperative complications
Prehabilitation
Surgical risk reduction
Smoking
Alcohol drinking
Physical activity
Malnutrition
Obesity
Patient preferences
Randomised controlled trial
Additional relevant MeSH terms:
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Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms