Automated Smoking Cessation Outreach for Cancer Patients

Overseen By Edgar Yu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Hospitalized, No phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

400 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a multi-arm, randomized controlled, pilot study which will recruit cancer patients who have been seen by a UCSF Cancer Center-affiliated clinical department to evaluate the efficacy of "CareConnect". This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response (IVR) delivering cancer-targeted educational messages to support referral to smoking cessation resources for patients with cancer.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment AutoReach, CareConnect, Ask-Advise-Connect (AAC) with Interactive Voice Response (IVR) for smoking cessation in cancer patients?

The Ask-Advise-Connect (AAC) approach has shown effectiveness in linking smokers to Quitline services, with 94.8% of those contacted enrolling in treatment, indicating its potential to engage patients in smoking cessation. Additionally, using electronic health records to identify and refer smokers to treatment programs has been shown to improve engagement rates, suggesting that these methods can effectively support smoking cessation efforts in cancer patients. ^{1 2 3 4 5}

Is the Automated Smoking Cessation Outreach for Cancer Patients generally safe for humans?

The studies reviewed focus on the implementation and effectiveness of smoking cessation programs, but they do not report any specific safety concerns related to the interventions, suggesting that these programs are generally considered safe for human participants. ^{1 2 5 6 7}

How is the CareConnect treatment different from other smoking cessation treatments for cancer patients?

CareConnect is unique because it uses an automated system to connect cancer patients with smoking cessation support through their electronic health records, making it easier for healthcare providers to identify smokers and refer them to treatment. This approach streamlines the process and increases the likelihood of patients engaging in smoking cessation programs, which is often a challenge in traditional settings. ^{1 2 4 6 8}

Research Team

Janice Tsoh, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adult cancer patients who smoke or use tobacco, including e-cigarettes. Participants must understand English, Spanish, Cantonese, or Mandarin and be willing to sign a consent form. They should have visited a UCSF Cancer Center-affiliated department recently.

Inclusion Criteria

Self-reported current use of tobacco, including e-cigarette on EHR

I am 18 years old or older.

I understand and can follow the study's procedures.

Exclusion Criteria

Contraindication to any study-related procedure or assessment

No valid contact telephone number

Currently hospitalized or having been discharged from inpatient setting within the past month (according to EHR)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants are enrolled and complete a baseline assessment. They receive automated calls/SMS texts for tobacco cessation intervention.

1 week

1 call (automated), 1 SMS (automated)

Intervention

Participants receive CareConnect or AutoReach calls/SMS texts, including assessments, motivational enhancement, and referral options for tobacco cessation.

3 months

Up to 2 calls (automated), 1 SMS (automated) per contact attempt

Follow-up

Participants are monitored for acceptance of referrals and satisfaction with the intervention. A 3-month survey is conducted.

3 months

1 survey (online, telephone, or postal mail)

In-depth Interviews (Optional)

Selected participants undergo in-depth semi-structured qualitative interviews.

1 month

Treatment Details

Interventions

• AutoReach
• Biospecimen samples
• CareConnect

Trial Overview The study tests 'CareConnect', which combines advice on quitting smoking with automated phone messages tailored for cancer patients. It aims to see if this helps more people quit smoking compared to usual care methods.

Participant Groups

Group I: CareConnect (Intervention) Experimental Treatment 2 Interventions

Participants will receive automated 'CareConnect' calls/SMS text at enrollment. The call protocol includes up to 2 calls on 2 consecutive days if no response to first call. If there is no response to call, a follow up SMS 3-4 days later. Each CareConnect contact will include (1) assessment, (2) motivational enhancement tailored to participants' tobacco use status and importance of quitting; and (3) multiple referral options (UCSF Fontana Tobacco Treatment Center (FTTC)/tobacco treatment specialist, Quitline, or smoke-freeTXT from smokefree.gov), offered after the motivational enhancement message. CareConnect will notify UCSF tobacco treatment specialist of participants acceptance of any of referral options. Referral options will be documented by specialists on the participants electronic health record (EHR). Participants who have completed the CareConnect call will be contacted by research staff for a 3-month survey to be completed online, by telephone, or postal mail.

Group II: AutoReach (Control) Experimental Treatment 2 Interventions

Participants will receive automated AutoReach calls/Short Message Service (SMS) text at enrollment provides one referral option (speaking with a tobacco treatment specialist) and an option for sending information on cessation resources. All participants who have completed the AutoReach call will be contacted by research staff for a 3-month survey to be completed online, by telephone or postal mail.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Findings from Research

A novel automated Patient Reported Outcomes (PRO) tobacco use screener was implemented in the electronic health record system, allowing 4589 cancer patients to be screened, with 3.6% identified as recent smokers.

Of those who screened positive, nearly 50% engaged in smoking cessation treatment, suggesting that this system may enhance the identification of smokers and improve treatment engagement compared to traditional methods in oncology settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Patient Reported Outcomes Measurement via the Electronic Health Record to Connect Patients with Cancer to Smoking Cessation Treatment. May, JR., Klass, E., Davis, K., et al.[2020]

The Ask-Advise-Connect (AAC) approach effectively linked 12% of current smokers at a Federally Qualified Health Center to Quitline services, demonstrating its potential to enhance smoking cessation efforts in low-socioeconomic status communities.

Post-implementation feedback from clinic staff indicated that AAC was easy to implement and positively impacted patient care, suggesting it could become a standard practice for smoking cessation in similar healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The implementation of ask-advise-connect in a federally qualified health center: a mixed methods evaluation using the re-aim framework. Shorey Fennell, B., Cottrell-Daniels, C., Hoover, DS., et al.[2023]

Approximately 45% of cancer patients had missing tobacco use history in their electronic medical records, highlighting a significant gap in screening that could affect treatment outcomes.

Stakeholders expressed a strong interest in improving tobacco screening and cessation services, but identified barriers such as cultural differences, time constraints, and lack of training, indicating a need for tailored interventions to enhance tobacco cessation efforts among diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation planning for equitable tobacco treatment services: a mixed methods assessment of contextual facilitators and barriers in a large comprehensive cancer center. Tsui, J., Sloan, K., Sheth, R., et al.[2023]

The ELEVATE program significantly increased the proportion of tobacco smokers receiving cessation treatment from 1.6% to 27.9% after its implementation, demonstrating a 16.9 times higher relative risk of treatment reach compared to pre-implementation.

The program also improved smoking cessation rates from 12.0% to 17.2%, indicating that integrating a low-burden tobacco treatment strategy into cancer care can effectively enhance both treatment access and cessation outcomes for patients who smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased Reach and Effectiveness With a Low-Burden Point-of-Care Tobacco Treatment Program in Cancer Clinics. Ramsey, AT., Baker, TB., Stoneking, F., et al.[2023]

In a study involving 1785 participants, the standard quitline treatment was highly effective, with a 30-day quit rate of 61.2% at 12 months, demonstrating that traditional methods remain successful in helping smokers quit.

Adding an interactive voice response (IVR) system for relapse risk assessments did not significantly improve quit rates compared to standard treatment, indicating that while the IVR identified at-risk individuals, it did not enhance overall effectiveness in preventing relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. McDaniel, AM., Vickerman, KA., Stump, TE., et al.[2019]

This study is a randomized controlled trial involving 460 smokers, assessing the effectiveness of a chat-bot intervention for smoking cessation compared to usual treatment, with a focus on long-term nicotine abstinence validated by chemical testing at 6 months.

The research aims to provide evidence on the effectiveness of technology-based interventions in smoking cessation, potentially improving accessibility and adherence to treatment while ensuring patient safety through scientific validation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). Avila-Tomas, JF., Olano-Espinosa, E., Minué-Lorenzo, C., et al.[2020]

Continued smoking after a cancer diagnosis significantly increases the risk of mortality and second primary cancers, highlighting the importance of effective smoking cessation strategies for cancer patients.

In a study involving 134 current smokers identified from a cancer clinic, only 12 enrolled in a patient navigation intervention, with only 6 engaging in cessation treatment, indicating that while patients found the intervention satisfactory, the low recruitment rates suggest challenges in implementing this approach effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. Fan, T., Yingst, JM., Bascom, R., et al.[2022]

The study aims to develop a smoking cessation support chatbot specifically for ambivalent smokers, with a focus on understanding their preferences through a survey of 300 participants.

The chatbot's acceptability and feasibility will be tested with 25 individuals over a 2-week period, with the goal of creating a prototype that can eventually be tested for efficacy in promoting smoking behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study. Nair, US., Greene, K., Marhefka, S., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Leveraging Patient Reported Outcomes Measurement via the Electronic Health Record to Connect Patients with Cancer to Smoking Cessation Treatment. [2020]

2. England pubmed.ncbi.nlm.nih.gov

The implementation of ask-advise-connect in a federally qualified health center: a mixed methods evaluation using the re-aim framework. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Implementation planning for equitable tobacco treatment services: a mixed methods assessment of contextual facilitators and barriers in a large comprehensive cancer center. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Increased Reach and Effectiveness With a Low-Burden Point-of-Care Tobacco Treatment Program in Cancer Clinics. [2023]

5. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to prevent smoking relapse among recently quit smokers enrolled in employer and health plan sponsored quitlines. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a chat-bot for the adult population to quit smoking: protocol of a pragmatic clinical trial in primary care (Dejal@). [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Patient Navigation-Based Smoking Cessation Program in Cancer Patients. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Development of a Conversational Agent for Individuals Ambivalent About Quitting Smoking: Protocol for a Proof-of-Concept Study. [2023]