Back to resultsThe Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer
Primary Purpose
Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Behavioral: Motivational Interviewing with WhatsApp video call
Sponsored by
About this trial
This is an interventional supportive care trial for Non-Muscle Invasive Bladder Cancer
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)
Sites / Locations
- İrem Nur Ozdemir
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental: Intervention Group
No Intervention: Control Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Tumor Recurrence
Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Progression
Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Full Information
NCT ID
NCT05704231
First Posted
December 22, 2022
Last Updated
January 20, 2023
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05704231
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors, Tumor Recurrence, Progression, Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a parallel group randomized controlled study.
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Intervention Group
Arm Type
Experimental
Arm Description
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
Arm Title
No Intervention: Control Group
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Motivational Interviewing with WhatsApp video call
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-efficacy for managing chronic disease 6-item scale.
Description
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.
Time Frame
Change from chronic disease self-efficacy at 12 months
Title
Glover Nilsson Smoking Behavioral Questionnaire
Description
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.
Time Frame
Change from smoking behavior at 12 months
Secondary Outcome Measure Information:
Title
Tumor Recurrence
Description
Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Time Frame
Change from tumor recurrence and progression at 12 months
Title
Progression
Description
Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Time Frame
Change from progression at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İREM NUR ÖZDEMİR, PhD, RN.
Phone
+905076472107
Email
iremozdemir92@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
İrem Nur Özdemir, PhD, RN
Organizational Affiliation
Bakırköy Dr. Sadi Konuk
Official's Role
Principal Investigator
Facility Information:
Facility Name
İrem Nur Ozdemir
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26879805
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.
Results Reference
result
PubMed Identifier
35818122
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.
Results Reference
result
PubMed Identifier
15586136
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.
Results Reference
result
PubMed Identifier
20855414
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.
Results Reference
result
Learn more about this trial
The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer
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