Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05643469 |
| Other study ID # |
2022.447-T |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 3, 2023 |
| Est. completion date |
June 2026 |
Study information
| Verified date |
August 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
Ho Cheung William Li, PhD |
| Phone |
39430889 |
| Email |
williamli[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Objective: To test the efficacy of a self-determination theory-based intervention plus
instant messaging to help smokers with cancer quit smoking.
Hypothesis to be tested: Subjects who are allowed to choose their quit schedule and receive
regular instant messaging about smoking cessation will show a significantly higher
biochemically validated quit rate than those who receive only brief advice to quit
immediately.
Design and Subjects: An RCT will be conducted to 1448 smokers with cancer attending the
outpatient clinics of five major acute care hospitals in Hong Kong for medical follow-up.
Instruments: A structured questionnaire will be used to assess subjects' smoking history and
demographic and clinical characteristics. EQ-5D-5L will be used to measure subjects' quality
of life.
Interventions: The intervention group will receive brief advice and will be invited to choose
their own quit schedules (immediate or progressive) in the outpatient clinics. They will
receive instant messaging about smoking cessation during the first 6-month follow-up period.
The control group will receive brief advice to quit smoking immediately in the outpatient
clinics, and will receive a placebo intervention during the first 6-month follow-up period.
Subjects in both groups will receive leaflets on smoking cessation.
Description:
Setting:
The setting is outpatient clinics of five major acute care hospitals in different clusters in
Hong Kong.
Intervention group
In outpatient clinics Subjects will first receive a brief intervention using the Ask, Warn,
Advise, Refer, and Do-it-again (AWARD) model. Previous clinical trials of smoking cessation
have provided evidence of the effectiveness of brief interventions using the AWARD model. The
brief intervention will comprise the following steps: (1) ask about smoking history; (2) warn
about the high morbidity and mortality risks associated with smoking; (3) advise to quit:
subjects will be allowed to select their own quit schedules after discussing their situation
with the research nurse [quit immediately (QI), or quit progressively (QP) with the ultimate
goal of complete cessation]. The content Scripts for the QI and QP interventions will
emphasize the health benefits of quitting; (4) refer smokers to a smoking cessation clinic or
a smoking cessation hotline: 1833183; and (5) do it again: repeat the intervention and
encourage smokers who fail to quit or relapse to try again during each telephone follow-up.
The whole intervention will last approximately 5-8 minutes. This brief intervention will be
cost-effective and more feasible for routine use in clinical practice by healthcare
professionals after minimal training.
Subjects who opt to quit progressively will receive a smoking reduction leaflet, which
contains reduction strategies and a suggested plan to reduce smoking. Subjects will also be
given the option to consider a tailored quit schedule for themselves after the discussions
with the research nurse. The research nurse will motivate subjects to reduce cigarette
consumption and then quit at their own pace, but the whole process should not exceed 6
months.
At the end of the face-to-face session, subjects will be informed that over the next 6
months, the research nurse will help them to adhere to their schedules by sending
WhatsApp/WeChat messages. Each subject will receive a specially designed leaflet for smokers
with cancer entitled, 'It is never too late to quit smoking.' The content will highlight
smoking risks, the benefits of quitting, and myths about quitting smoking. The advisory
messages given to subjects will be standardized with reference to the specially designed
leaflet.
Follow-up booster intervention During the first 3 months of the study, the research nurse
will deliver WhatsApp/WeChat messages at least once per week. In addition, subjects will
receive four independent 1-minute videos (one video will be sent in weeks 1, 5, 9, and 13)
via WhatsApp/WeChat. The video content will focus on the health benefits of smoking cessation
after a cancer diagnosis. Between the 3-month and 6-month follow-up assessments, infrequent
messages (approximately one WhatsApp/WeChat message per month) will be sent by the research
nurse to follow the subjects ' progress, respond to their questions, and maintain contact.
Control group
In outpatient clinics Subjects will receive a brief intervention using the AWARD model.
However, all subjects will be advised to quit immediately. Control group subjects will
receive the same leaflet for smokers with cancer as intervention group subjects.
Follow-up Subjects will receive a placebo intervention that follows the same WhatsApp/WeChat
schedule as the intervention group, but the messages will contain only general health advice,
such as to perform more physical activity and eat more fruit and vegetables. The control
group will not receive any videos.
Training and quality assurance All research nurses will attend a training workshop conducted
by the research team before the study starts to ensure that they have the necessary knowledge
and skills to deliver smoking cessation advice using the AWARD model. Regular case
conferences, quality checks using audiotaping, and audit procedures will be conducted to
maintain the quality and uniformity of the interventions. Moreover, research nurses will be
trained to screen for eligible cases and conduct baseline/follow-up surveys and biochemical
validation.
Quality and data security control:
The proposed study will follow the quality assurance protocol developed for a previous
project. The principal investigator (PI), co-investigators (Co-Is), project coordinator, and
research nurses will organize meetings with the Chief of Service, nurse managers, and
frontline nurses to explain the protocol and the study logistics, and to examine the physical
facilities available in the outpatient clinics. The project coordinator will be present
during the first week to monitor the subject recruitment and data collection processes. All
completed questionnaires will be sealed in separate opaque envelopes that will be kept in
secure lockers provided by the outpatient clinics. The project coordinator will personally
collect the completed questionnaires weekly. All collected questionnaires will be stored in a
secure locker and the keys will be kept in our department. The project coordinator and other
research assistant(s) involved in this project will be responsible for entering the data into
SPSS software, and the resulting dataset will be encrypted and stored on an assigned computer
in our department. Only the PI, Co-Is, project coordinator, relevant research assistants,
independent data monitoring committee, and institutional review board will have access to the
data.
Subject recruitment We will obtain ethical approval from the institutional review boards of
the five hospitals. Potential subjects will be assessed for eligibility, and the purpose,
design, procedures, and potential benefits and risks of the study will be explained to them.
Informed written consent will then be sought. All subjects will be assured that their
participation will be voluntary, with no prejudice attached to refusal, and that the
information they provide will be kept confidential.
Data processing and analysis
Process evaluation will be conducted with subjects after the 12-month follow-up. Process
evaluation can help to identify the strengths and limitations of a new care delivery model
from the subjects' perspective. Moreover, process evaluation can help to identify the most
important elements of the intervention and improve future implementation of the intervention.
Most importantly, it provides information about optimizing the quality and efficacy of a
newly developed model of care. Based on their smoking status, 40 subjects from the
intervention group (20 quitters and 20 non-quitters) will be interviewed and a final sample
will be determined using data saturation. A one-to-one audiotaped semi-structured in-depth
interview (face-to-face) will be conducted with each subject.
Sample size G*Power will be used to estimate the sample size, following two previous RCTs. We
predict that the proposed intervention will result in at least a 4% difference (7% vs 3%) in
biochemically validated abstinence between the two groups at 6 months. The research team has
reached a consensus that such changes constitute a minimally importance difference (i.e. are
clinically significant) and thus warrant a change in patient management. To detect a
significant difference between intervention and control group quit rates with a power of 90%
and a significance level of 5%, at least 507 subjects will be needed per group. To allow a
potential retention rate of 70% at the 12-month follow-up, 1448 subjects will be recruited.
Data Analysis The baseline characteristics of the two groups will first be compared using the
chi-square test for categorical variables and analysis of variance for continuous variables.
Intention-to-treat analysis will be used by imputing all non-responses at follow-up by
baseline values (i.e. assuming failure or no change after the intervention), to yield more
conservative effect size estimates.
The primary analysis will involve (1) main effect: intervention vs. control on biochemically
validated quit rates at 12 months using chi-square test or Fisher's exact test.
The secondary analyses will include (2) main effect adjusting for baseline difference; (3)
all secondary outcomes at 6 and 12 months; and (4) use of a generalized estimating equation
model to calculate the adjusted ORs for validated and self-reported abstinence after
adjusting for fixed clustering effects, baseline demographic and clinical characteristics
that show a significant difference, and the within- subjects effect of the repeated measure
outcomes (3, 6, and 12 months).
Sensitivity analyses (e.g. complete case or per protocol) for the primary and secondary
outcomes will be conducted, depending on the observed pattern of missing data, using several
methods of statistical imputation (e.g. multiple imputations/completed case/last observation
carried forward) to assess the robustness of the findings. Subgroup analysis will be
conducted to explore any interaction effects.
Our health economist will conduct a CEA using standard methods. The CEA will be populated
using the empirical 12-month RCT data. An ingredients approach will be used to estimate the
cost of the intervention program, including intervention materials (e.g. leaflet and videos),
administration fees, and time taken to deliver the intervention. The health effectiveness
outcomes will include the number of quitters at 6 and 12 months and QALY. EQ-5D-5L utility
scores at baseline and follow-up assessments will be used to construct the QALY measure using
the area under the receiver operating characteristic curve approach. Treatment costs for
smoking-associated morbidities and relative risks will be extracted from the literature and
the intervention costs derived from the RCT. Incremental cost-effectiveness ratios in the
form of incremental cost per incremental QALY gained from the intervention, and incremental
cost per one additional quitter, will be calculated. Both deterministic and probabilistic
sensitivity analyses will be conducted to test the robustness of the model.
The process evaluation data analysis will begin immediately after each individual interview
in accordance with the thematic analysis framework introduced by Braun and Clarke, using
NVivo version 12 (QSR International Pty Ltd, 2018). The recordings will be fully transcribed
verbatim, in Cantonese, to capture nuances of expression unique to the dialect, and selected
quotations relevant to the themes will be later translated into English. During the coding
process, two researchers will be responsible for analysing the narratives. The analyses will
begin with an intensive examination of the transcripts to search for general constructs and
themes. Special attention will be given to constructs that diverge from the major topics as
framed by the guiding questions. The transcripts will first be coded using the open coding
method. Details in the interview conversations will be closely examined to allow a large
number of initial categories to emerge. As the number of codes increases, some closely
related codes will be merged, resulting in a smaller, more manageable set of codes. Selective
coding will then be used to code the transcripts using the established categories. Finally, a
complete set of codes will be generated to facilitate comparisons and the development of
themes and categories. Codes, categories, and themes generated will be compared with the
established taxonomy for evaluating intervention quality related to behavioural change
techniques for smoking cessation. The research team has considerable experience in conducting
qualitative research and will strictly follow the CONSORT-EHEALTH statement.
