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Smoking Cessation in Cancer Patients

This study is not yet open for participant recruitment.
Verified September 2012 by The University of Hong Kong
Sponsor:
Collaborators:
Food and Health Bureau, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Information provided by (Responsible Party):
Prof. Sophia Siu-chee Chan, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01685723
First received: August 26, 2012
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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: Test the effectiveness of a tailored and targeted smoking cessation intervention

Hypothesis: We hypothesize that improving risk communication could significantly increase the quit rate of smoking cancer patients

Design: Cluster randomized controlled trial

Setting: Outpatient clinics in Queen Mary Hospital and Tuen Mun Hospital (Clinical Oncology Departments)

Subject: Smoking patients who have diagnosed cancer with stable condition and treatments

Intervention: At baseline, intervention group receives:

  1. health warnings of smoking from oncologists/nurses based on a special design leaflet;
  2. a patient-centred counseling from nurse counselors with emphasis on risk perceptions of smoking to cancer prognosis; and
  3. examination of exhale CO level. They will receive up to 8 more telephone counseling within 1 month by nurse counselor to reinforce the importance to quit and assist to solve any barriers. Control group 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. change in risk perceptions of smoking;
  2. change in the intention to quit;
  3. validated 6-month quit rate;
  4. patient's smoking reduction by at least 50% compared to baseline;
  5. quit attempt(s);
  6. change in health related quality of life; and
  7. cancer recurrence rate at 6-month.

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


Condition Intervention
Cancer
Smoking Cessation
 Behavioral: Counseling group
Behavioral: General supporting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Helping Cancer Patients Quit Smoking by Improving Their Risk Communication: a Cluster Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • The self-reported 7-day point prevalence (pp) quit rate at the sixth month [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Whether the participant has quitted smoking in the past seven days at the time point of 6 months


Secondary Outcome Measures:
  • Change in patients' smoking behavior and risk perceptions at the sixth month [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    - 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 ] [ Designated as safety issue: No ]
    • 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 ] [ Designated as safety issue: No ]
    - Biochemically validated quit rate (saliva cotinine level and exhale CO test)


Estimated Enrollment: 560
Study Start Date: September 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Counseling group

Subjects in this group will receive:

  • Health warning on smoking (with a special designed leaflet) by oncologist or nurse during consultation;
  • Face-to-face individual smoking cessation counseling by nurse counselor (15-30 minutes);
  • Assessment of exhale carbon monoxide level at baseline;
  • Nicotine replacement therapy (may be provided);
  • Generic self-help smoking booklet; and
  • Multiple telephone follow up counseling (up to 8 sessions) within one-month period (10-15 minutes).
 Behavioral: Counseling group
Subjects in this group will receive treatments in the form of improved risk communication measures. These measures include brief advice by oncologist or oncology nurses, a special design leaflet, face-to-face individualized risk communication counselling by nurse counselor, and follow-up telephone counselling emphasizing on risk communication.
Sham Comparator: General supporting

Subjects in this group will receive:

  • Usual care by oncologist or nurse;
  • General care and support by nurse counselor (5 minutes);
  • Generic self-help smoking cessation booklet; and
  • Multiple telephone follow-ups (up to 8 sessions) to show support and care for patients' disease condition (5 minutes).
 Behavioral: General supporting

Subjects in this group will receive:

  • Usual care by oncologist or nurse;
  • General care and support by nurse counselor (5 minutes);
  • Generic self-help smoking cessation booklet; and
  • Multiple telephone follow-ups (up to 8 sessions) to show support and care for patients' disease condition (5 minutes).

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 tailored smoking cessation intervention 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cancer patients smoked weekly in the past 6 months;
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685723

Contacts
Contact: Sophia SC Chan, PhD, MPH 852-28192610 nssophia@hku.hk

Locations
China
The University of Hong Kong Not yet recruiting
Hong Kong SAR, China
Principal Investigator: Sophia SC Chan, PhD            
Sponsors and Collaborators
The University of Hong Kong
Food and Health Bureau, Hong Kong
Queen Mary Hospital, Hong Kong
Tuen Mun Hospital
Investigators
Principal Investigator: Sophia SC Chan, PhD, MPH The University of Hong Kong
  More Information

Publications:

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
Study First Received: August 26, 2012
Last Updated: September 11, 2012
Health Authority: Hong Kong: Hospital Authority

Keywords provided by The University of Hong Kong:
Cancer patients
Smoking cessation
Risk communication

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on June 17, 2013