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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT05704231
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2022-12-22
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-30
• Last Update Posted: 2023-01-30
• Study Start: 2023-02-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glover Nilsson Smoking Behavioral Questionnaire	Change from smoking behavior at 12 months	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.
Self-efficacy for managing chronic disease 6-item scale.	Change from chronic disease self-efficacy at 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Tumor Recurrence	Change from tumor recurrence and progression at 12 months	Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Progression	Change from progression at 12 months	Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Trial Locations

Locations (1)

İrem Nur Ozdemir; 🇹🇷 Istanbul, Turkey