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

NCT ID: NCT05704231

Last Updated: 2023-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a parallel group randomized controlled study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Single (Participant)

Study Groups

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Experimental: Intervention Group

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

Group Type EXPERIMENTAL

Behavioral: Motivational Interviewing with WhatsApp video call

Intervention Type BEHAVIORAL

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.

No Intervention: Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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İrem Nur Özdemir, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Bakırköy Dr. Sadi Konuk

Locations

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İrem Nur Ozdemir

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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İREM NUR ÖZDEMİR, PhD, RN.

Role: CONTACT

+905076472107

References

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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.

Reference Type RESULT
PMID: 26879805 (View on PubMed)

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.

Reference Type RESULT
PMID: 35818122 (View on PubMed)

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.

Reference Type RESULT
PMID: 15586136 (View on PubMed)

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.

Reference Type RESULT
PMID: 20855414 (View on PubMed)

Other Identifiers

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iremozdemir

Identifier Type: -

Identifier Source: org_study_id

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