Against All Odds -Prehabilitation in Urologic Cancer Surgery
|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 : Not yet recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Complications Bladder Cancer||Behavioral: Prehabilitation||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|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|
|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|
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.
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.
- 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)
- 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
- 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
- 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
- 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))
- 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.
- 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)
- 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)