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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called CareConnect, designed to help cancer patients quit smoking. CareConnect uses phone calls and text messages to motivate and connect patients with smoking cessation resources. Participants will receive either CareConnect or a simpler program, AutoReach, which offers fewer options. The trial seeks cancer patients who currently use tobacco and have visited a UCSF Cancer Center in the last 3 months. As an unphased trial, it offers a unique opportunity for patients to access innovative support methods for quitting smoking.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Ask-Advise-Connect (AAC) approach, part of the CareConnect system, helps more people attempt to quit smoking and encourages participation in support programs. This method enhances communication between doctors, nurses, and patients about quitting smoking.

The Interactive Voice Response (IVR) system, another component of CareConnect, also appears helpful for smoking cessation, though further research is needed to understand it better.

Specific safety data for CareConnect itself is unavailable due to its novelty. However, its components, like AAC and IVR, have been used previously to aid smoking cessation and are generally well-tolerated, meaning adverse reactions are uncommon.

Since CareConnect employs methods already known to be safe, it is expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Automated Smoking Cessation Outreach trial for cancer patients because it tests two innovative approaches to help people quit smoking. The CareConnect system stands out by offering personalized motivational messages and multiple referral options, like the UCSF Fontana Tobacco Treatment Center and smoke-freeTXT, tailored to each participant's smoking status and readiness to quit. This method aims to enhance engagement and provide more comprehensive support compared to the standard care options. Meanwhile, AutoReach simplifies the process by providing straightforward referrals to tobacco treatment specialists, which could make quitting more accessible. By exploring these methods, researchers hope to discover more effective ways to support smoking cessation among cancer patients.

What evidence suggests that this trial's treatments could be effective for smoking cessation in cancer patients?

Research shows that the Ask-Advise-Connect (AAC) approach, a key component of the CareConnect system, helps people quit smoking. In this trial, participants in the CareConnect arm will receive automated calls and SMS texts incorporating AAC, which has greatly increased the number of smokers receiving support from quitlines. This method involves healthcare providers asking patients about their smoking, advising them to quit, and connecting them directly to helpful resources. The CareConnect system also uses Interactive Voice Response (IVR) technology to enhance this process by sending personalized educational messages and boosting involvement. Early results from similar programs suggest that these automated systems can help more smokers quit, especially those with serious health issues like cancer. Meanwhile, participants in the AutoReach arm will receive automated calls and SMS texts offering a single referral option to speak with a tobacco treatment specialist. ^{2 6 7 8 9}

Who Is on the Research Team?

Janice Tsoh, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 understand and can follow the study's procedures.

I have been diagnosed with cancer.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05829824

Tobacco Cessation Care for Cancer Patients by Automated ... This is the first study to assess the efficacy CareConnect, a combination of the Ask-Advise-Connect (AAC) with an Interactive Voice Response ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05829824

Tobacco Cessation Care for Cancer Patients by Automated ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4023543/

Efficacy of Ask Advise Connect in a Safety Net Healthcare ... A strength is that AAC was evaluated in a setting representative of real-world healthcare systems that serve smokers disproportionately burdened by tobacco.

4. moqc.org moqc.org/wp-content/uploads/2017/08/Ask-Advise-Connect-Concept_JAMA-Internal-Medicine-2013.pdf

Ask-Advise-Connect The LVNs and MAs at the AAC clinics were trained to ask all patients at every visit about their smoking status at the time that other vital signs were assessed, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3858085/

Ask Advise Connect: A New Approach to Smoking ... This study reports the findings of a group randomized trial designed to evaluate a new approach to disseminating quitline-delivered cessation treatment through ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05829824

Tobacco Cessation Care for Cancer Patients by Automated ... 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 ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK597153/

Adding a Teachable Moment Approach to a Team-Based ... This project aimed to (1) improve delivery and documentation of tobacco-cessation care to disadvantaged patients using an Ask-Advise-Connect (AAC) systems-based ...

8. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-023-00535-0

Implementation of ask-advise-connect for smoking cessation ... The Ask-Advise-Connect (AAC) approach can help primary care providers to increase the number of people who attempt to quit smoking and enrol into cessation ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11243215/

Interactive voice response (IVR) for tobacco cessation IVR appears to be a promising intervention for tobacco cessation. However, pilot programmes and research addressing literature gaps are necessary.