Text-Based Smoking Cessation Program for Rural Cancer Survivors

Recruiting at 219 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Alliance for Clinical Trials in Oncology

Must not be taking: Nicotine replacement, Bupropion, Varenicline

Disqualifiers: Psychiatric illness, Impaired decision-making

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

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.

What data supports the effectiveness of the Text-Based Smoking Cessation Program for Rural Cancer Survivors treatment?

Research shows that text messaging programs are effective for helping people quit smoking. Studies have found that these programs improve smoking abstinence in the general population and are feasible and acceptable for rural older adults, making them a promising option for rural cancer survivors. ^{1 2 3 4 5}

Is the Text-Based Smoking Cessation Program safe for humans?

Text-based smoking cessation programs, which use mobile phone text messages to help people quit smoking, are generally considered safe for humans. They have been found to be feasible and acceptable, with participants reporting that they are useful and would recommend them to others. ^{1 3 4 5 6}

How is the Text-Based Smoking Cessation Program for Rural Cancer Survivors different from other smoking cessation treatments?

The Text-Based Smoking Cessation Program is unique because it uses automated text messages to support quitting smoking, making it easily accessible and feasible for rural cancer survivors who may have limited access to traditional in-person programs. This approach can enhance motivation and provide ongoing support, which is particularly beneficial for those in remote areas. ^{1 3 4 6 7}

Research Team

Devon Noonan, PhD, MPH, FNP-BC

Principal Investigator

Duke School of Nursing

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Text-Based Cessation Intervention (Behavioral 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.

Participant Groups

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 China for the following indications:

Approved in China as Mobile Health Intervention for:

• Smoking cessation

Who Is Running the Clinical Trial?

Alliance for Clinical Trials in Oncology

Lead Sponsor

Trials

521

Recruited

224,000+

Suzanne George

Alliance for Clinical Trials in Oncology

Chief Medical Officer since 2015

MD from Harvard Medical School

Evanthia Galanis

Alliance for Clinical Trials in Oncology

Chief Executive Officer since 2022

MD from Mayo Clinic

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility of a text-based smoking cessation intervention in rural older adults. [2019]

2. England 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. [2020]

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

How do smokers use a smoking cessation text messaging intervention? [2018]

4. England pubmed.ncbi.nlm.nih.gov

Engagement and Short-term Abstinence Outcomes Among Blacks and Whites in the National Cancer Institute's SmokefreeTXT Program. [2022]

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

Efficacy of SMS Text Message Interventions for Smoking Cessation: A Meta-Analysis. [2022]

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

Text messaging-based smoking cessation intervention: a narrative review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Pilot RCT results of stop my smoking USA: a text messaging-based smoking cessation program for young adults. [2022]