Targeted Self-Help for Quitting Smoking in Cancer Patients

Overseen By Heather Anderson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Male breast cancer

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new self-help program designed to motivate cancer patients to quit smoking. It targets those recently diagnosed with certain cancers, such as breast, colorectal, gynecological, skin melanoma, or bladder cancer. Participants will receive either the usual care or the usual care plus this targeted self-help intervention (a print-based self-help program) to determine its effectiveness in helping them quit smoking. Those who have smoked at least one cigarette in the past month and are not currently in a smoking cessation program might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance smoking cessation support for cancer patients.

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

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

What prior data suggests that this self-help intervention is safe for cancer patients?

Research has shown that printed self-help materials can assist people trying to quit smoking, especially those without other support. These materials help more people stop smoking compared to doing nothing at all.

In this study, the self-help materials are unique because they are personalized for cancer patients who smoke, aiming to boost their motivation to quit. No reports of negative effects have emerged from using these materials, as they are educational rather than a physical treatment or medication.

Thus, this method is generally safe. It focuses on providing information and motivation, which is unlikely to cause harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Targeted Self-Help intervention for quitting smoking in cancer patients because it offers a personalized approach, unlike the standard nicotine replacement therapies or prescription medications. This method is customized to each patient's needs, potentially increasing motivation and adherence compared to generic programs. Additionally, by integrating psychological support in a self-directed format, it empowers patients to take control of their quitting journey, which could lead to improved outcomes and a higher success rate in quitting smoking.

What evidence suggests that the Targeted Self-Help intervention is effective for quitting smoking in cancer patients?

Research shows that self-help materials can aid smoking cessation, especially when other support is unavailable. Evidence indicates that printed self-help materials are more effective than no intervention in helping people quit smoking. This trial will compare the effectiveness of usual care alone with usual care plus the Targeted Self-Help Intervention. Self-help tools, such as workbooks and online programs, can enhance quality of life and reduce stress for cancer patients. While this study focuses on cancer patients, earlier research found that these materials can also motivate smoking cessation in this group. ^{1 2 3 6 7}

Who Is on the Research Team?

Ursula Martinez, PhD

Principal Investigator

Huntsman Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals over 18 who smoke and have been diagnosed with breast, colorectal, gynecological, skin melanoma, or bladder cancer within the last 6 months. Participants must be able to read/write English and give informed consent. Men with breast cancer or those already in a smoking cessation program cannot join.

Inclusion Criteria

Able to read/write English

Able to give informed consent

Not currently enrolled in a smoking cessation program

Exclusion Criteria

I am not a male with breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a brief self-help intervention targeted by cancer type to increase motivation to quit smoking

2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for adherence, retention, and acceptability of the intervention

1 month

2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Targeted Self-Help

Trial Overview

The study is testing a new brief self-help intervention designed specifically for different types of cancer to see if it helps smokers increase their motivation to quit. It will be compared against the usual care given to smokers.

How Is the Trial Designed?

Group I: Usual Care + Targeted Self-Help Intervention Experimental Treatment 1 Intervention

Group II: Usual Care Active Control 1 Intervention

Targeted Self-Help is already approved in United States, European Union for the following indications:

Approved in United States as Targeted Self-Help Intervention for:

• Smoking cessation

Approved in European Union as Tailored Self-Help Materials for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 35 cancer patients who wanted to quit smoking without assistance, 43.76% achieved a 50% reduction in smoking, but only 12.50% managed to abstain for 30 days, indicating that while some success was possible, it decreased with stricter definitions of quitting.

The study highlighted a strong initial intention to quit among participants, but few utilized tobacco treatments, suggesting a need for interventions that encourage the use of evidence-based support for smoking cessation in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The natural trajectory of smoking cessation among cancer patients who want to quit "on their own": A mixed-methods, longitudinal study. Borger, T., Feather, AR., Wakeman, KE., et al.[2023]

A self-help workbook intervention for cancer patients undergoing chemotherapy did not significantly improve overall quality of life (QOL) or survival rates, based on a randomized controlled trial with 200 participants.

However, among patients who continued chemotherapy for 24 weeks, the workbook was associated with a significant improvement in emotional functioning, suggesting it may help with emotional distress during long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial. Takano, T., Matsuda, A., Ishizuka, N., et al.[2021]

The interactive self-help workbook significantly reduced posttraumatic stress, helplessness/hopelessness, and cognitive avoidance in 49 women recently diagnosed with breast cancer, indicating its efficacy as a supportive intervention.

Despite its benefits, the workbook was associated with poorer body image among participants, suggesting that body image concerns require separate attention in treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial to evaluate the effects of a self-help workbook intervention on distress, coping and quality of life after breast cancer diagnosis. Beatty, LJ., Koczwara, B., Rice, J., et al.[2020]

A guided self-help intervention for psychological distress in head and neck and lung cancer patients was found to be generally beneficial, with most participants reporting reduced distress and valuable life insights after the program.

Patients had mixed experiences with the intervention, highlighting the importance of tailoring support to individual needs, as some found it helpful while others felt it was too confrontational or temporarily distressing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guided self-help intervention targeting psychological distress among head and neck cancer and lung cancer patients: motivation to start, experiences and perceived outcomes. Krebber, AH., van Uden-Kraan, CF., Melissant, HC., et al.[2022]

Intensive combined behavioral and pharmacological interventions are the most effective strategies for smoking cessation among cancer patients, with randomized-controlled trials showing abstinence rates between 5.2% and 75%.

Despite the effectiveness of these interventions, many studies suffer from quality issues, such as inadequate verification of abstinence, indicating a need for improved research methodologies in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of smoking cessation interventions among persons with cancer: A systematic review. Yingst, JM., Carrillo, M., Chan, KH., et al.[2023]

A systematic review of 9 studies involving 1149 cancer patients found that web-based self-management interventions significantly improved quality of life and reduced depression among participants, with a notable effect size for both outcomes.

Patients who engaged in these interventions reported lower cancer-related distress and higher self-efficacy compared to those who did not receive the intervention, highlighting the potential benefits of online support for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based self-management intervention for patients with cancer: A meta-analysis and systematic review. Zhang, X., Ma, L., Feng, L.[2022]

A randomized controlled trial involving 414 cancer patients assessed the efficacy of a self-help smoking-relapse prevention intervention, which included standard care plus additional resources like booklets and an educational DVD.

The primary goal is to evaluate the effectiveness of this low-cost intervention in preventing smoking relapse, which could significantly reduce negative health outcomes associated with continued smoking after a cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial. Díaz, DB., Brandon, TH., Sutton, SK., et al.[2018]

A study involving women smokers with young children found that a tailored self-help guide did not significantly improve smoking cessation rates compared to standard guides, with only 12.5% reporting not smoking for at least a week after 6 months.

Despite the expectation that tailored materials would be more effective, the results indicated no significant differences in quitting behavior or methods used among the three different self-help guides provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of tailored self-help smoking cessation guides on young mothers. Davis, SW., Cummings, KM., Rimer, BK., et al.[2019]

The Internet-based self-management program (IBSMP) significantly reduces fatigue and related symptoms in cancer survivors, as shown by a meta-analysis of 13 randomized controlled trials involving 1603 patients.

The IBSMP also effectively improves sleep quality and reduces levels of depression and anxiety among cancer patients, indicating its potential as a valuable rehabilitation tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of the Internet-based self-management program for cancer-related fatigue patients: a systematic review and meta-analysis. Huang, J., Han, Y., Wei, J., et al.[2022]

The Committed Quitters Program (CQP) significantly improved smoking cessation rates among participants, with 36.2% abstinence at 6 weeks and 27.6% at 12 weeks, compared to only 24.7% and 17.7% in the control group.

Both the CQP and the CQP with an outbound call showed similar effectiveness, indicating that tailored self-help materials can enhance the efficacy of nicotine replacement therapy beyond standard resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine polacrilex gum therapy. Shiffman, S., Paty, JA., Rohay, JM., et al.[2022]

In a study of 169 women undergoing breast cancer treatment, self-help interventions significantly reduced fatigue, pain, and nausea burdens, especially for those with high levels of depression.

The findings suggest that depression burden affects the severity and number of side effects experienced, highlighting the importance of assessing depression in women receiving cancer treatment to improve their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depression burden, self-help interventions, and side effect experience in women receiving treatment for breast cancer. Badger, TA., Braden, CJ., Mishel, MH.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7112723/

Print‐based self‐help interventions for smoking cessation - PMC

Moderate‐certainty evidence shows that when no other support is available, written self‐help materials help more people to stop smoking than no intervention.

2.

cochranelibrary.com

cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001118.pub4/full

Print‐based self‐help interventions for smoking cessation

We reviewed the evidence showing how effective printed self‐help materials are in helping people to quit smoking. We looked for studies of ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0169500219303307

Development of a targeted self-help smoking cessation ...

Effectiveness of smoking cessation self-help materials ... Patient reported outcome data as performance indicators in surgically treated lung cancer patients.

4.

withpower.com

withpower.com/trial/phase-smoking-6-2024-51ba7

Targeted Self-Help for Quitting Smoking in Cancer Patients

Research shows that self-help interventions, like workbooks and web-based programs, can improve quality of life and reduce distress in cancer patients. These ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39448437/

Motivating smoking cessation among patients with cancers not ...

This study evaluated feasibility for a future efficacy trial and assessed the acceptability of brief self-help materials, targeted by cancer type, to enhance ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06484179

Enhancing Motivation to Quit Smoking Via Self-Help ...

... self-help intervention targeted by cancer type to increase motivation to quit smoking. Official Title. Enhancing Motivation to Quit Smoking Via Self-Help ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714417300058

A randomized controlled trial of a smoking cessation self ...

This paper describes the intervention development, as well as the design, methods, and data analysis plans for an ongoing randomized controlled trial (RCT).