Self-determination Plus Instant Messaging for Smokers With Cancer

NCT05643469 | Recruiting DMC

• 1 other identifier: 2022.447-T
• Study Type: interventional
• Target: 1,448
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Cancer

Keywords

Cancer; Instant messaging; Self-determination; Outpatient clinics; Quality of life; Smoking cessation

Outcome Measures

Primary Outcomes (1)

• biochemically validated smoking abstinence (saliva cotinine level and Carbon monoxide level in expired air) at 6 months

  biochemically validated smoking abstinence at 6 months follow-up between intervention and control group. The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of \<30 ng/ml with a saliva cotinine test paper and a carbon monoxide level in expired air of \<4 parts per million (ppm) with a carbon monoxide monitor.

  6 months follow-up

Secondary Outcomes (7)

• biochemically validated smoking abstinence (saliva cotinine level and carbon monoxide level in expired air) at 12 months

  12 months follow-up

• self-reported 7-day point prevalence of smoking abstinence at 6 months measured by structured questionnaires

  6 months follow-up

• self-reported 7-day point prevalence of smoking abstinence at 12 months measured by structured questionnaires

  12 months follow-up

• self-reported reduction of ≥50% cigarette consumption at 6 months measured by structured questionnaires

  6 months follow-up

• self-reported reduction of ≥50% cigarette consumption at 12 months measured by structured questionnaires

  12 months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

Each subject will receive a specially designed leaflet for smokers with cancer. subjects will receive brief interventions using the AWARD model and they will be allowed to select their own quit schedules (quit immediately, or quit progressively) with the ultimate goal of complete cessation. Subjects who opt to quit progressively will receive a smoking reduction leaflet. Over the next 6 months, the research nurse will help them to adhere to their schedules by sending WhatsApp/WeChat messages. subjects will receive four independent 1-minute videos (one video will be sent in weeks 1, 5, 9, and 13) via WhatsApp/WeChat.

Other: Self-determination theory-based intervention plus instant messaging

Control group

PLACEBO COMPARATOR

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. 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.

Other: AWARD model

Interventions

AWARD model OTHER

Subjects will receive a brief intervention using the AWARD model and all of them will advise to quit immediately. Only general health advice via WhatsApp/WeChat will be delivered.

Control group

Self-determination theory-based intervention plus instant messaging OTHER

subjects will receive brief interventions using the AWARD model and they will be allowed to select their own quit schedules (quit immediately, or quit progressively) with the ultimate goal of complete cessation. Follow-up booster intervention with WhatsApp/WeChat messages to help them to adhere to their schedules and independent 1-minute videos will be delivered.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoked weekly in the last 6 months,
• diagnosed with any cancer for at least 6 months and at all cancer stages (I, II, III, or IV),
• aged 18 years or above and can communicate in Cantonese, and
• own a smartphone and able to use instant messaging (e.g. WhatsApp or WeChat)

You may not qualify if:

• individuals with unstable medical conditions, poor cognitive state, or mental illness as advised by the doctor in charge and noted on their medical records, and
• those participating in other smoking cessation programmes.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Smoking; Neoplasms; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Ho Cheung William Li, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Cheung William Li, PhD

CONTACT

39430889; williamli@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: July 3, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: After the project is completed and the results of the project has been published
• Access Criteria: Request could be sent to Principal Investigator (williamli@cuhk.edu.hk)

Locations

HK (1)