The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

Study Overview
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Brief Summary
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This study will be carried out to examine the effect of telephone-assisted smoking cessation program on self-efficacy, smoking behavior, tumor recurrence and progression in patients with non-muscle invasive bladder cancer.

Detailed Description
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This study will be conducted to examine the effect of a telephone-assisted smoking cessation program (3 months) on self-efficacy, smoking behavior, tumor recurrence and progression for chronic disease management in patients diagnosed with non-muscle invasive bladder cancer. After 3 months of motivational interviewing was applied to the experimental group, the scales will be applied in the 3rd, 6th and 12th months. The cystoscopy will be performed at 3 and 12 months for tumor recurrence and progression

Official Title
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The Effect of Telephone-Assisted Smoking Cessation Program on Self-Efficacy, Smoking Behavior, Tumor Recurrence and Progression in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

Conditions
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Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors, Tumor Recurrence, Progression, Disease

Intervention / Treatment
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* Behavioral: Behavioral: Motivational Interviewing with WhatsApp video call


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being 21 years or older First-time diagnosis of non-muscle invasive bladder cancer (patients with pTa urothelial cancer) Chronic smoking for at least 1 year At least primary school graduate and can speak Turkish Having a smartphone and internet access No communication barrier (speech, vision or hearing problem) Individuals who agree to participate in the research. Exclusion Criteria: Patients with positive CIS (carcinoma in situ) Patients with minimal invasion of the lamina propria and above Patients with extravesical extension Patients with synchronous and metachronous tumors Communication disability (speech, vision or hearing problem)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study is a parallel group randomized controlled study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention Group<br>Motivational Interviewing with WhatsApp video call The individuals in the intervention group will be given a smoking cessation education and motivational interview with a WhatsApp video call for 3 months. The motivational interview will be applied every two weeks, 6 times in total. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the intervention. tumor recurrence and progression will be checked by cystoscopy at 3rd and 12th months | Behavioral: Behavioral: Motivational Interviewing with WhatsApp video call<br>* The intervention group will be given a motivational interview with a WhatsApp video call for 3 months. Motivational interviews will be applied every two weeks, 6 times in total.<br>|
| No Intervention: No Intervention: Control Group<br>the control group received the routine care/education provided in the hospital. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the routin hospital care. Both intervention and control groups' tumor recurrence and progression will be checked by cystoscopy at the 3rd and 12th months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for managing chronic disease 6-item scale. | The scale is rated on a 10-point scale ranging from not at all sure to very sure. The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than one answer is given to an item and the items follow each other, the lower score is included in the calculation. In order to calculate the scale, at least 4 items must be answered. The Croncbach's alpha coefficient was 0.91 and the mean of the original scale was 5.17 ± 2.22. Turkish validity and reliability was done by İncirkuş and Nahcivan (2020). The Cronbach's alpha coefficient of the scale was found to be 0.90. | Change from chronic disease self-efficacy at 12 months | 
| Glover Nilsson Smoking Behavioral Questionnaire | The Turkish validity and reliability of the scale was done by Sancar. The scale was created as a scale with 11 questions as a result of the Turkish adaptation study, and each question is scored from 0 to 4 with a 5-option scoring system. Behavioral addiction score below 12 is mild, 12 and 22 moderate, 23-33 strong, 33 above very strong behavioral addiction score has been suggested. The scale is a valid and reliable scale that can be used to determine the behavioral aspect of smoking addiction of smokers, both in its one-dimensional and 2-dimensional form. The Croncbach alpha coefficient was found to be 0.82. This value indicates that the scale is quite reliable in terms of internal consistency. The Conditioning and Significance sub-dimension of the scale consists of 5 items and the Cronbach's alpha coefficient is 0.762. The Handling and Emotions sub-dimension consists of 6 items and the Cronbach's alpha coefficient is 0.735. | Change from smoking behavior at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Recurrence | Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention. | Change from tumor recurrence and progression at 12 months | 
| Progression | Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention. | Change from progression at 12 months |