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Smoking Cessation in Cancer Patients

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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

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.


Condition or disease Intervention/treatment Phase
Cancer Smoking Cessation Behavioral: Counseling group Behavioral: General supporting Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 528 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial
Actual Study Start Date : September 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

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.
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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Biochemical validation of smoking status at 6 months [ Time Frame: 6 months ]
    Biochemically validated quit rate (saliva cotinine level and exhale CO test)

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685723


Locations
China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
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
Principal Investigator: Sophia SC Chan, PhD, MPH The University of Hong Kong

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Sophia Siu-chee Chan, Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01685723     History of Changes
Other Study ID Numbers: cancer_rct_1
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Prof. Sophia Siu-chee Chan, The University of Hong Kong:
Cancer patients
Smoking cessation
Risk communication