Non-Muscle Invasive Bladder CancerNCT05704231
The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer
A study testing Behavioral: Motivational Interviewing with WhatsApp video call in people with Non-Muscle Invasive Bladder Cancer and Self Efficacy, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors
- What is being tested?
- Behavioral: Motivational Interviewing with WhatsApp video call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors, Tumor Recurrence, Progression, Disease
- Being tested
- Behavioral: Motivational Interviewing with WhatsApp video call
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Smoking, Recurrence, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Motivational Interviewing with WhatsApp video callBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intervention Group | Experimental | 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 Receives: Behavioral: Behavioral: Motivational Interviewing with WhatsApp video call |
| No Intervention: Control Group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from chronic disease self-efficacy at 12 months
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.
Measured: Change from smoking behavior at 12 months
Secondary outcomes (2)
Tumor Recurrence
Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Measured: Change from tumor recurrence and progression at 12 months
Progression
Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.
Measured: Change from progression at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel group randomized controlled study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- İrem Nur Özdemir, PhD, RN, Principal investigator, Bakırköy Dr. Sadi Konuk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704231
- Sponsor's protocol ID
- iremozdemir
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26879805Taylor 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.
PubMed 35818122Wakefield 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.
PubMed 15586136Thomsen 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.
PubMed 20855414
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05704231
- Acronym / sponsor ID
- iremozdemir
- Conditions
- Non-Muscle Invasive Bladder Cancer, Self Efficacy, Smoking Behaviors, Tumor Recurrence, Progression, Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a parallel group randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Group | Experimental | Behavioral: Behavioral: Motivational Interviewing with WhatsApp video callMotivational 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 |
| No Intervention: Control Group | No intervention | –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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Motivational Interviewing with WhatsApp video callThe 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. | Behavioural | Experimental: Intervention Group |
Primary outcome
Self-efficacy for managing chronic disease 6-item scale.
Time frame: 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.
Glover Nilsson Smoking Behavioral Questionnaire
Time frame: 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.
2 secondary outcomes
Tumor Recurrence
Time frame: Change from tumor recurrence and progression at 12 months
Progression
Time frame: Change from progression at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Results publication: PubMed 26879805Spencer 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 publication: PubMed 35818122Taylor 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 publication: PubMed 15586136Wakefield 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 publication: PubMed 20855414Thomsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İrem Nur Özdemir, PhD, RN principal investigator
Bakırköy Dr. Sadi Konuk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Motivational Interviewing with WhatsApp video call in people with Non-Muscle Invasive Bladder Cancer and Self Efficacy, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İREM NUR ÖZDEMİR, PhD, RN. (+905076472107, iremozdemir92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy for managing chronic disease 6-item scale. (time frame: Change from chronic disease self-efficacy at 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05704231, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.