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

Self Efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05704231
• Other study ID #: iremozdemir
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2023
• Source: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
• Contact: IREM NUR ÖZDEMIR, PhD, RN.
• Phone: +905076472107
• Email: iremozdemir92[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease Progression
• Non-Muscle Invasive Bladder Cancer
• Progression, Disease
• Recurrence
• Self Efficacy
• Smoking Behaviors
• Tumor Recurrence
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Behavioral: Motivational Interviewing with WhatsApp video call
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.

Locations

Country	Name	City	State
Turkey	Irem Nur Ozdemir	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Spencer JC, Wheeler SB. A systematic review of Motivational Interviewing interventions in cancer patients and survivors. Patient Educ Couns. 2016 Jul;99(7):1099-1105. doi: 10.1016/j.pec.2016.02.003. Epub 2016 Feb 8. — View Citation

Taylor KL, Williams RM, Li T, Luta G, Smith L, Davis KM, Stanton CA, Niaura R, Abrams D, Lobo T, Mandelblatt J, Jayasekera J, Meza R, Jeon J, Cao P, Anderson ED; Georgetown Lung Screening, Tobacco, and Health Trial. A Randomized Trial of Telephone-Based S — View Citation

Thomsen T, Tonnesen H, Okholm M, Kroman N, Maibom A, Sauerberg ML, Moller AM. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial. Nicotine Tob Res. 2010 Nov;12(11):1118-24. doi: 10.1093/ntr/ntq158. Epu — View Citation

Wakefield M, Olver I, Whitford H, Rosenfeld E. Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Nurs Res. 2004 Nov-Dec;53(6):396-405. doi: 10.1097/00006199-200411000-00008. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Incirkus 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
Primary	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	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
Secondary	Progression	Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.	Change from progression at 12 months