CancerNCT01685723
Smoking Cessation in Cancer Patients
A study testing Counseling group and General supporting in people with Cancer and Smoking Cessation, run by The University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Smoking Cessation
- What is being tested?
- Counseling group and General supporting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 528 participants
- Where
- 1 siteChina
- Study dates
- Sep 2012to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial
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
Read more
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:
- a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors;
- examination of exhale CO level; and
- 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:
- self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;
- biochemically validated quit rate at 6-month follow-up; and
- 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.
Read the 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.
- Conditions
- Cancer, Smoking Cessation
- Being tested
- Counseling group, General supporting
- Keywords
- Cancer patients, Smoking cessation, Risk communication
- Medical subject headings
- Neoplasms, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling groupBehavioural
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.
General supportingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Counseling group | Experimental | 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. Receives: Behavioral: Counseling group |
| General supporting | Sham comparator | 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. Receives: Behavioral: General supporting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The self-reported 7-day point prevalence (pp) quit rate at 6 months
Whether the participant has quitted smoking in the past seven days at the time point of 6 months
Measured: 6 months
Secondary outcomes (4)
The self-reported 7-day point prevalence (pp) quit rate at 12 months
Whether the participant has quitted smoking in the past seven days at the time point of 12 months
Measured: 12 months
Biochemical validation of smoking status at 6 months
Biochemically validated quit rate (saliva cotinine level and exhale CO test)
Measured: 6 months
Percentage of patients reduced smoking by at least 50% at 6 months
Percentage of patients reduced smoking by at least 50% at 6 months
Measured: Baseline and 6 months
Percentage of patients reduced smoking by at least 50% at 12 months
Percentage of patients reduced smoking by at least 50% at 12 months
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 528 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Prof. Sophia Siu-chee Chan, The University of Hong Kong
- Investigators
- Sophia SC Chan, PhD, MPH, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685723
- Sponsor's protocol ID
- cancer_rct_1
- Status last verified
- Jan 2018
- First submitted
- 26 Aug 2012
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benninger MS, Gillen J, Thieme P, Jacobson B, Dragovich J. Factors associated with recurrence and voice quality following radiation therapy for T1 and T2 glottic carcinomas. Laryngoscope. 1994 Mar;104(3 Pt 1):294-8. doi: 10.1288/00005537-199403000-00009.
PubMed 8127185Browman GP, Wong G, Hodson I, Sathya J, Russell R, McAlpine L, Skingley P, Levine MN. Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):159-63. doi: 10.1056/NEJM199301213280302.
PubMed 8417381Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. doi: 10.1259/0007-1285-63-751-554.
PubMed 2390690Chen J, Jiang R, Garces YI, Jatoi A, Stoddard SM, Sun Z, Marks RS, Liu Y, Yang P. Prognostic factors for limited-stage small cell lung cancer: a study of 284 patients. Lung Cancer. 2010 Feb;67(2):221-6. doi: 10.1016/j.lungcan.2009.04.006. Epub 2009 Jun 3.
PubMed 19497635Li WH, Chan SS, Wang KM, Lam TH. Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial. BMC Cancer. 2015 Jun 30;15:490. doi: 10.1186/s12885-015-1496-2.
PubMed 26122078
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Cancer Patients Quit Smoking Using Brief Advice Based on Risk Communication: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01685723
- Acronym / sponsor ID
- cancer_rct_1
- Conditions
- Cancer, Smoking Cessation
- Keywords
- Cancer patients, Smoking cessation, Risk communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 528 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- 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
- Study start
- Sep 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- a face-to-face individualized brief advice based on risk communication for 15-30 minutes from the nurse counselors;
- examination of exhale CO level; and
- 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:
- self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up;
- biochemically validated quit rate at 6-month follow-up; and
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Counseling group | Experimental | Behavioral: Counseling groupSubjects 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. |
| General supporting | Sham comparator | Behavioral: General supportingSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling groupSubjects 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. | Behavioural | Counseling group |
| General supportingSubjects 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. | Behavioural | General supporting |
Primary outcome
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
4 secondary outcomes
The self-reported 7-day point prevalence (pp) quit rate at 12 months
Time frame: 12 months
Biochemical validation of smoking status at 6 months
Time frame: 6 months
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 12 months
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Background: PubMed 8127185Benninger MS, Gillen J, Thieme P, Jacobson B, Dragovich J. Factors associated with recurrence and voice quality following radiation therapy for T1 and T2 glottic carcinomas. Laryngoscope. 1994 Mar;104(3 Pt 1):294-8. doi: 10.1288/00005537-199403000-00009.
- Background: PubMed 8417381Browman GP, Wong G, Hodson I, Sathya J, Russell R, McAlpine L, Skingley P, Levine MN. Influence of cigarette smoking on the efficacy of radiation therapy in head and neck cancer. N Engl J Med. 1993 Jan 21;328(3):159-63. doi: 10.1056/NEJM199301213280302.
- Background: PubMed 2390690Rugg T, Saunders MI, Dische S. Smoking and mucosal reactions to radiotherapy. Br J Radiol. 1990 Jul;63(751):554-6. doi: 10.1259/0007-1285-63-751-554.
- Background: PubMed 19497635Chen J, Jiang R, Garces YI, Jatoi A, Stoddard SM, Sun Z, Marks RS, Liu Y, Yang P. Prognostic factors for limited-stage small cell lung cancer: a study of 284 patients. Lung Cancer. 2010 Feb;67(2):221-6. doi: 10.1016/j.lungcan.2009.04.006. Epub 2009 Jun 3.
- Derived from this study: PubMed 26122078Li WH, Chan SS, Wang KM, Lam TH. Helping cancer patients quit smoking by increasing their risk perception: a study protocol of a cluster randomized controlled trial. BMC Cancer. 2015 Jun 30;15:490. doi: 10.1186/s12885-015-1496-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia SC Chan, PhD, MPH principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling group and General supporting in people with Cancer and Smoking Cessation, run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The self-reported 7-day point prevalence (pp) quit rate at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01685723, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.