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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05704231
Enrollment
60
Registered
2023-01-30
Start date
2023-02-01
Completion date
2024-06-01
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BEHAVIORALBehavioral: 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.

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

Single (Participant)

Intervention model description

This study is a parallel group randomized controlled study.

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Self-efficacy for managing chronic disease 6-item scale.Change from chronic disease self-efficacy at 12 monthsThe 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.
Glover Nilsson Smoking Behavioral QuestionnaireChange from smoking behavior at 12 monthsThe 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.

Secondary

MeasureTime frameDescription
Tumor RecurrenceChange from tumor recurrence and progression at 12 monthsTumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.
ProgressionChange from progression at 12 monthsProgression will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Countries

Turkey (Türkiye)

Contacts

Primary ContactİREM NUR ÖZDEMİR, PhD, RN.
iremozdemir92@gmail.com+905076472107

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026