Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smoking Cessation in Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01685723
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
Food and Health Bureau, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Queen Elizabeth Hospital, Hong Kong
Princess Margaret Hospital, Hong Kong
Pamela Youde Nethersole Eastern Hospital
Information provided by (Responsible Party):
Prof. Sophia Siu-chee Chan, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE August 26, 2012
First Posted Date  ICMJE September 14, 2012
Last Update Posted Date January 23, 2018
Actual Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
The self-reported 7-day point prevalence (pp) quit rate at 6 months [ Time Frame: 6 months ]
Whether the participant has quitted smoking in the past seven days at the time point of 6 months
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
The self-reported 7-day point prevalence (pp) quit rate at the sixth month [ Time Frame: Six months ]
Whether the participant has quitted smoking in the past seven days at the time point of 6 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2018)
  • The self-reported 7-day point prevalence (pp) quit rate at 12 months [ Time Frame: 12 months ]
    Whether the participant has quitted smoking in the past seven days at the time point of 12 months
  • Biochemical validation of smoking status at 6 months [ Time Frame: 6 months ]
    Biochemically validated quit rate (saliva cotinine level and exhale CO test)
  • Percentage of patients reduced smoking by at least 50% at 6 months [ Time Frame: Baseline and 6 months ]
    Percentage of patients reduced smoking by at least 50% at 6 months
  • Percentage of patients reduced smoking by at least 50% at 12 months [ Time Frame: Baseline and 12 months ]
    Percentage of patients reduced smoking by at least 50% at 12 months
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2012)
  • Change in patients' smoking behavior and risk perceptions at the sixth month [ Time Frame: Baseline and 6 months ]
    • Proportion of participants reduced daily cigarette consumption by at least half compared with baseline
    • Proportion of patients with quit attempt(s)
    • Patients' intention to quit smoking
    • Change in patients' risk perceptions
    • Change in health-related quality of life
  • Biochemical validation of smoking status at the sixth month [ Time Frame: 6 months ]
    - Biochemically validated quit rate (saliva cotinine level and exhale CO test)
  • Change in patients' smoking behavior and risk perceptions at the twelfth month [ Time Frame: Baseline and 12 months ]
    • Self-reported 7-day point prevalence (pp) quit rate
    • Proportion of participants reduced daily cigarette consumption by at least half compared with baseline
    • Proportion of patients with quit attempt(s)
    • Patients' intention to quit smoking
    • Change in patients' risk perceptions
    • Change in health-related quality of life
    • Actuarial overall survival rate
  • Biochemical validation of smoking status at twelfth month [ Time Frame: 12 months ]
    - Biochemically validated quit rate (saliva cotinine level and exhale CO test)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking Cessation in Cancer Patients
Official Title  ICMJE Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial
Brief Summary

Background: Smoking cessation can largely improve cancer prognosis and quality of life among cancer patients. However, few patients are aware of the importance to quit at the stage, or they have difficulties to quit by self.

Aim: to examine the effectiveness of a smoking cessation intervention using a risk communication approach

Design: A randomized controlled trial

Setting: Outpatient clinics of the Clinical Oncology Departments of five major hospitals in different regions of Hong Kong

Subject: Smokers who attend medical follow-up visits at outpatient clinics of the Clinical Oncology Departments of five major hospitals in different regions of Hong Kong and who met the inclusion criteria were invited to participate.

Intervention: At baseline, intervention group receives:

  1. a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors;
  2. examination of exhale CO level; and
  3. a generic standard self-help smoking cessation booklet. They will receive a booster intervention at 1 week. Control group will receive standard care and a generic self-help smoking cessation booklet.

Outcome: Primary outcome is the self-reported 7-day point prevalence quit rate at 6-month follow up. Secondary outcomes include:

  1. self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;
  2. biochemically validated quit rate at 6-month follow-up; and
  3. percentage of patients reduced smoking by at least 50% at 6- and 12-month follow-up compared to baseline.

Significance: This study develops and validates practical smoking cessation interventions targeted to cancer patients to improve their cancer prognosis and in long-term.

Detailed Description

Smoking causes many types of cancer in general. Past studies have shown that current smokers have increased risk of cancer, and most lung cancers are attributable to smoking. Cancer (malignant neoplasm) is the number one killer in Hong Kong, which leads to nearly one-third of all deaths each year. Cancer patients who continue smoking would result in extra risks of all cause mortality, cancer recurrence and second primary cancer as well as reducing survival time (Chen et al., 2010). Smoking could also reduce the efficacy of clinical and medical treatment of cancer including radio- and chemo-therapies (Benninger et al., 1994; Browman et al., 1993) and increase the risk of treatment related side-effects (Rugg et al., 1990).

Cancer patients may present an excellent "teachable moment" for smoking cessation interventions, as their current illness could largely be due to smoking. However, few smoking cessation programs target on this vulnerable group and only one-third of oncology nurses would assist cancer patients quit smoking. Healthcare professionals have the responsibility to assist this vulnerable group to quit smoking. Recent randomized controlled trials (RCT) suggested behavioral intervention may help cancer patients quit smoking, but they are limited by small sample size. No RCT study has ever been done in Hong Kong.

This study can make an important contribution to evidence-based practice by testing the effectiveness of a smoking cessation intervention using a risk communication approach and targeting cancer patients. The results primarily serve the purpose to support the development of clinical practice guidelines and interventions to promote smoking cessation in cancer patients to improve their cancer prognosis and, in the long-run, increase their survival time and quality of life.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Smoking Cessation
Intervention  ICMJE
  • Behavioral: Counseling group
    Subjects will receive brief advice based on risk communication by a nurse counselor. The brief advice will be based on a specifically-designed risk communication leaflet that warns about the risks of continued smoking for subjects' cancer treatment and prognosis. Subjects will receive a booster intervention via telephone at 1 week to assess the progress of and barriers to the subjects' action plans and identifying individual difficulties and facilitators towards quitting. They also receive a generic standard self-help smoking cessation booklet.
  • Behavioral: General supporting
    Subjects in this group will receive a generic self-help smoking cessation booklet and standard care without risk communication. They will have the same follow-up sections as the intervention group to receive diseases support.
Study Arms  ICMJE
  • Experimental: Counseling group

    Subjects in this group will receive a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors and a booster intervention (10-15 minutes) at 1 week.

    Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.Ten subjects from the intervention group who have not quitted will be invited for a process evaluation in the form of face-to-face interviews by research assistants at 12-month follow-up.

    Intervention: Behavioral: Counseling group
  • Sham Comparator: General supporting

    Subjects in this group will receive standard care without risk communication.

    Data collection will be conducted at 1 week, 1, 3, 6, 9, 12 months via telephone.

    Intervention: Behavioral: General supporting
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 19, 2018)
528
Original Estimated Enrollment  ICMJE
 (submitted: September 11, 2012)
560
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients smoked at least weekly in the past 6 months;
  • diagnosed with cancer not limited to smoking-induced cancers;
  • patients in all stages 0,I,II,III, or IV;
  • aged 18 or above; and
  • can communicate in Cantonese

Exclusion Criteria:

  • those with unstable medical conditions as advised by the doctor in charge;
  • poor cognitive state or with mental illness; and
  • those participating in other smoking cessation program.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01685723
Other Study ID Numbers  ICMJE cancer_rct_1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof. Sophia Siu-chee Chan, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE
  • Food and Health Bureau, Hong Kong
  • Queen Mary Hospital, Hong Kong
  • Tuen Mun Hospital
  • Queen Elizabeth Hospital, Hong Kong
  • Princess Margaret Hospital, Hong Kong
  • Pamela Youde Nethersole Eastern Hospital
Investigators  ICMJE
Principal Investigator: Sophia SC Chan, PhD, MPH The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP