Clinical trial NCT05704231: The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Muscle Invasive Bladder Cancer
Self Efficacy
Smoking Behaviors
Tumor Recurrence
Progression, Disease
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a parallel group randomized controlled study.
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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)

Primary outcomes:
measure: Self-efficacy for managing chronic disease 6-item scale.
timeFrame: Change from chronic disease self-efficacy at 12 months
measure: Glover Nilsson Smoking Behavioral Questionnaire
timeFrame: Change from smoking behavior at 12 months
Secondary outcomes:
measure: Tumor Recurrence
timeFrame: Change from tumor recurrence and progression at 12 months
measure: Progression
timeFrame: Change from progression at 12 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İrem Nur Ozdemir
Study officials:
affiliation: Bakırköy Dr. Sadi Konuk
name: İrem Nur Özdemir, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 Smoking Cessation Treatment in the Lung Cancer Screening Setting. J Natl Cancer Inst. 2022 Oct 6;114(10):1410-1419. doi: 10.1093/jnci/djac127.
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.
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. Epub 2010 Sep 20.