Text-Based Smoking Cessation Program for Rural Cancer Survivors

Recruiting at 234 trial locations

Overseen By Samer S. Kasbari

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Nicotine replacement, Bupropion, Varenicline

Disqualifiers: Psychiatric illness, Impaired decision-making

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a text-based program can help rural cancer survivors quit smoking more effectively than a booklet. Participants will receive either scheduled text messages to gradually reduce smoking or a booklet with quitting tips. Suitable candidates include those diagnosed with cancer in the last 10 years, currently smoking at least 5 cigarettes daily, living in a rural area, and having a phone capable of receiving texts. As a Phase 3 trial, this study represents the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you are not currently using any smoking cessation medications like nicotine replacement therapy, bupropion, or varenicline. Other medications are not mentioned, so it's best to discuss with the trial team.

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

Research has shown that using text messages to help people quit smoking is generally safe. A review of 26 studies on mobile-based smoking support found that these programs can assist people in quitting smoking without major safety issues or serious side effects.

Text message programs are usually easy to manage because they don't involve surgery or needles. Participants receive encouraging messages and tips to help them quit smoking, which can keep them motivated. Since this method only uses text messages, it is less likely to cause harm compared to other medical treatments.

Overall, participants in similar programs from other studies did not report any major problems. This suggests that using text messages to quit smoking is a safe option for those who want to stop smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the text-based smoking cessation program because it offers a novel, accessible way to help rural cancer survivors quit smoking. Unlike traditional methods like nicotine replacement therapy or counseling, this program delivers support directly to participants' phones through text messages, providing continuous encouragement and guidance over 12 weeks. Additionally, the program includes a structured, gradual reduction plan that allows individuals to reduce smoking at a manageable pace, making it a potentially more sustainable option for those in rural areas who might have limited access to in-person resources.

What evidence suggests that this text-based cessation intervention is effective for quitting smoking?

Research has shown that text-based programs, like the one tested in this trial, can help people quit smoking. Participants may receive regular text messages offering support and motivation, which can increase their chances of quitting. One study found that people using text messages to quit smoking were more successful, particularly if they were motivated and not heavily addicted to nicotine. Another study found that text messaging not only helped people smoke less but also reduced harmful substances like carbon monoxide in their bodies. Overall, evidence suggests that text-based programs can be a powerful tool for quitting smoking, especially for those in rural areas with limited access to other resources. ^{2 3 6 7 8}

Who Is on the Research Team?

Devon Noonan, PhD, MPH, FNP-BC

Principal Investigator

Duke School of Nursing

Are You a Good Fit for This Trial?

This trial is for rural cancer survivors who currently smoke at least 5 cigarettes daily, have had a cancer diagnosis within the last decade, and may still be undergoing treatment. Participants must be adults with texting-capable phones, not using smoking cessation drugs or programs, able to read English, and willing to provide a urine sample.

Inclusion Criteria

Lives in a nonmetro/rural county (defined as having a Rural Urban Continuum Code [RUCC] code of 4-9)

Not currently using any smoking cessation pharmacotherapy (e.g. nicotine replacement therapy, bupropion or varenicline), or currently participating in any cessation program

Participant must be willing to provide a urine sample.

Exclusion Criteria

Psychiatric illness which would prevent the patient from giving informed consent

I am capable of making my own health decisions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants participate in a scheduled gradual reduction program over 8 weeks, receiving cessation support messages via text messages for 12 weeks

12 weeks

Follow-up

Participants are monitored for smoking cessation and quality of life at 6 months post-quit date

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Text-Based Cessation Intervention

Trial Overview The study compares a text-based program designed to help smokers quit by gradually reducing cigarette use against traditional methods like manuals. The goal is to see if scheduled texts can more effectively lead participants to stop smoking entirely.

How Is the Trial Designed?

Group I: Group I (SGR program, text messages) Experimental Treatment 3 Interventions

Patients participate in schedule gradual reduction program over 8 weeks to reduce the frequency of cigarette use. Patients also receive cessation support messages via text messages for 12 weeks.

Group II: Group II (booklet) Active Control 1 Intervention

Patients receive NCI's Clearing the Air booklet to help plan to gradually quit smoking.

Text-Based Cessation Intervention is already approved in United States, China, European Union for the following indications:

Approved in United States as Text-Based Smoking Cessation Program for:

• Smoking cessation

Approved in China as Mobile Health Intervention for:

• Smoking cessation

Approved in European Union as Automated Text Messaging Intervention for:

• Smoking cessation

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A meta-analysis of 13 randomized controlled trials found that SMS text message interventions increased smoking cessation rates by 36% compared to control groups, indicating their effectiveness in promoting quitting.

Interventions with a 3-month follow-up showed higher efficacy than those with a 6-month follow-up, and fixed message schedules were more effective than variable ones, suggesting that the timing and consistency of messages are important for success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. Spohr, SA., Nandy, R., Gandhiraj, D., et al.[2022]

In a study involving 924 smokers using the QuitTxt program, most participants (68.9%) preferred the default messaging frequency of 4-8 texts per day, and the median duration of use was 27 days, indicating a generally positive reception of the program.

Despite some users not fully reporting their quit status, many still found QuitTxt helpful, suggesting that consistent reporting may not be crucial for the program's effectiveness in supporting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How do smokers use a smoking cessation text messaging intervention? Balmford, J., Borland, R.[2018]

In a study of 8,487 participants in the SmokefreeTXT program, Black smokers were more likely to complete the program than White smokers, with an adjusted odds ratio of 1.71, indicating higher program retention.

Despite higher completion rates, Black participants were less engaged overall, responding less frequently to assessments and reporting lower abstinence rates, suggesting the need for further research to identify barriers to effective engagement and cessation among Black smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement and Short-term Abstinence Outcomes Among Blacks and Whites in the National Cancer Institute's SmokefreeTXT Program. Robinson, CD., Wiseman, KP., Webb Hooper, M., et al.[2022]

A hybrid intervention combining telephone counseling and text messaging was tested on 66 hospitalized smokers in Brazil, showing a higher rate of abstinence at 1-month (25.0% vs. 9.1%) and 3-month (31.8% vs. 9.1%) follow-ups compared to a standard care group.

Participants found the text messaging helpful (80.4% approval) and the counseling session appropriate in length (95.1% approval), indicating that this approach is not only effective but also well-received, making it a promising low-cost option for smoking cessation in middle- and lower-income countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Experimental Feasibility Study of a Hybrid Telephone Counseling/Text Messaging Intervention for Post-Discharge Cessation Support Among Hospitalized Smokers in Brazil. Cruvinel, E., Richter, KP., Colugnati, F., et al.[2020]

Text messaging interventions for smoking cessation show promise, with 22 studies indicating that these programs can effectively motivate individuals to quit smoking, particularly among adults aged 30-40 and young adults aged 18-29.

While some interventions demonstrated better smoking cessation outcomes than control conditions, more rigorous research is needed to identify the most effective components of these text messaging strategies to enhance their overall efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging-based smoking cessation intervention: a narrative review. Kong, G., Ells, DM., Camenga, DR., et al.[2022]

A text-based Scheduled Gradual Reduction (SGR) program for smoking cessation was found to be feasible and acceptable among rural adults over 60, with 81% of participants reading all messages.

While the SGR group showed a higher biochemically validated cessation rate (15%) compared to the control group (5%), the difference was not statistically significant, indicating potential effectiveness that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a text-based smoking cessation intervention in rural older adults. Noonan, D., Silva, S., Njuru, J., et al.[2019]

The Stop My Smoking (SMS) USA program, a text messaging-based intervention, significantly increased smoking cessation rates among young adults aged 18 to 25, with 39% of participants quitting at 4 weeks compared to 21% in the control group.

While the initial success at 4 weeks was promising, the difference in cessation rates was not maintained at 3 months, indicating the need for further research to understand the long-term effectiveness and identify which users benefit most from the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot RCT results of stop my smoking USA: a text messaging-based smoking cessation program for young adults. Ybarra, ML., Holtrop, JS., Prescott, TL., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6804292/

Mobile phone text messaging and app‐based interventions for ... The benefits of mobile phone‐based smoking cessation support (mCessation) interventions are: the ease of use anywhere at any time; cost‐effective delivery and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05008848

Reaching Rural Cancer Survivors Who Smoke Using Text- ... This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based scheduled ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2801838

Assessment of a Text Message–Based Smoking Cessation ... The intervention was most effective among smokers with low nicotine dependence and strong quitting intention. This study's findings also provide ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11480626/

Effectiveness of Text Messaging in Encouraging Smoking ... The text-messaging intervention proved effective in increasing the prevalence of smoking cessation and reducing carbon monoxide levels among non-communicable ...

5. withpower.com withpower.com/trial/phase-3-8-2021-d89c9

Text-Based Smoking Cessation Program for Rural Cancer ... This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit. Text-based ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3980005/

Text Messaging-Based Smoking Cessation Intervention Smoking cessation interventions delivered via text messaging on mobile phones may enhance motivations to quit smoking.

7. prevention.cancer.gov prevention.cancer.gov/clinical-trials/clinical-trials-search/nct05008848

Reaching Rural Cancer Survivors Who Smoke Using Text ... This phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients who smoke, quit.

8. pcna.net pcna.net/news/using-text-messaging-for-tobacco-cessation-in-rural-populations/

Using Text Messaging for Tobacco Cessation in Rural ... Whittaker and colleagues8 synthesized 26 studies that reviewed mobile-based cessation support through text messaging applications. They found ...