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

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05704231
Collaborator
(none)
60
1
2
16
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral: Motivational Interviewing with WhatsApp video call
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This study is a parallel group randomized controlled study.This study is a parallel group randomized controlled study.
Masking:
Single (Participant)
Masking Description:
Single (Participant)
Primary Purpose:
Supportive Care
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
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Behavioral: 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.

No Intervention: 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

Outcome Measures

Primary Outcome Measures

  1. Self-efficacy for managing chronic disease 6-item scale. [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.

  2. Glover Nilsson Smoking Behavioral Questionnaire [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.

Secondary Outcome Measures

  1. Tumor Recurrence [Change from tumor recurrence and progression at 12 months]

    Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.

  2. Progression [Change from progression at 12 months]

    Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 İrem Nur Ozdemir Istanbul Turkey

Sponsors and Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Investigators

  • Principal Investigator: İrem Nur Özdemir, PhD, RN, Bakırköy Dr. Sadi Konuk

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT05704231
Other Study ID Numbers:
  • iremozdemir
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023