Against All Odds -Prehabilitation in Urologic Cancer Surgery

• ClinicalTrials.gov Identifier: NCT04088968
• Recruitment Status: Not yet recruiting
• First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Sponsor: Bispebjerg Hospital
• Collaborators: Aarhus University Hospital; Copenhagen University Hospital at Herlev; Rigshospitalet, Denmark
• Information provided by (Responsible Party): Hanne Tonnesen, Bispebjerg Hospital

Study Description

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 neoadjuvant chemotherapy before radical cystectomy on postoperative complications.

Condition or disease	Intervention/treatment	Phase
Postoperative Complications; Bladder Cancer	Behavioral: Prehabilitation	Not Applicable

Detailed Description:

The study is a multicenter randomised controlled trial involving 110 bladder cancer patients screened positive for at least 1 SNAP factor and undergoing neoadjuvant chemotherapy before radical cystectomy.

Patients allocated to the intervention group will receive five counselling sessions in 6 weeks including an integrated prehabilitation program covering the time period until surgery tailored to meet the individual patient's need for risk reduction. Patients are ensured that they are free to access support to lifestyle changes in the community.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 110 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised Controlled Trial
• Masking: Single (Outcomes Assessor)
• Masking Description: Outcome assessors will not know if patients were allocated to intervention or control group
• Primary Purpose: Prevention
• Official Title: Efficacy of Intensive Smoking Nutrition Alcohol Physical Activity(SNAP) Intervention Among Patients With at Least 1 SNAP Factor and Undertaking Neoadjuvant Chemotherapy Before Radical Cystectomy - a Randomised Controlled Trial.
• Estimated Study Start Date: February 1, 2020
• Estimated Primary Completion Date: January 31, 2023
• Estimated Study Completion Date: January 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Prehabilitation; Intervention: Patients allocated to the intervention group receive min. five 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, stress reduction
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.

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. Adherence to the intervention [ Time Frame: After 6 weeks, day at surgery, 6 months ]
   The percentage of patients who are adherent, i.e., who fulfill ≥ 75% of each component in the individual designed intervention. Measured by meetings attended, log-book notes
2. Smoking and Alcohol cessation [ Time Frame: During 6 weeks, day at surgery and 6 months after surgery ]
   Number of patients quitting smoking and number of patients quitting drinking/reducing alcohol intake. Measured breath tests and alcohol biomarkers
3. Physical activity and Nutrition [ Time Frame: After 6 weeks, day at surgery, 6 months ]
   Number of patients who maintain baseline functional and nutritional status. Physical activity measured by 6 Minutes walk test (&MWT) and Timed up and go(TUG) as difference in walking distance adjusted to age and gender. Nutrition measured by handgrip-strength and
4. Health related quality of life(HRQoL) [ Time Frame: After 6 weeks, day at surgery, 6 months ]
   Mean difference of HRQoL between groups measured with European Organization for Research and Treatment of Cancer 30-item core quality of life questionnaire (EORTC QLQ-C30 (scale range 0-100, a higher score indicating better quality of life))
5. Health related quality of life(HRQoL) [ Time Frame: After 6 weeks, day at surgery, 6 months ]
   Mean difference of HRQoL between groups measured with European Organization for Research and Treatment of Cancer quality of life questionnaire for patients with muscle invasive bladder cancer (QLQ-BLM30 (scale range 0-100, a higher score indicating increase in symptom burden)) will be used.
6. Health related quality of life (HRQoL) [ Time Frame: After 6 weeks, day at surgery, 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)
7. Patient satisfaction [ Time Frame: After 6 weeks, day at surgery, 6 months ]
   Mean difference in patient satisfaction between groups measured with EORTC QLQSAT32 ( satisfaction with care)

Eligibility Criteria

• 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Hanne Tonnesen, Professor, Bispebjerg Hospital
• ClinicalTrials.gov Identifier: NCT04088968
• Other Study ID Numbers: Against All Odds -WP4
• First Posted: September 13, 2019
• Last Update Posted: September 13, 2019
• Last Verified: September 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Postoperative Complications; Pathologic Processes