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

Trial Summary

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 data supports the effectiveness of the treatment 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 findings suggest that similar self-help approaches might also help cancer patients quit smoking. ^{1 2 3 4 5}

Is the Targeted Self-Help treatment safe for cancer patients?

The research on self-help interventions, including workbooks and web-based programs, for cancer patients does not report any safety concerns, suggesting they are generally safe to use. ^{1 3 4 5 6}

How is the Targeted Self-Help treatment for quitting smoking in cancer patients different from other treatments?

The Targeted Self-Help treatment is unique because it provides personalized self-help materials tailored to the specific needs of cancer patients who smoke, unlike standard generic self-help materials that have been largely ineffective. This approach leverages the 'teachable moment' of a cancer diagnosis to encourage meaningful changes in smoking behavior without relying on medication or traditional counseling. ^{7 8 9 10 11}

What is the purpose of this trial?

The purpose of this research study is assess feasibility and acceptability of a recently developed brief self-help intervention targeted by cancer type to increase motivation to quit smoking.

Research Team

Ursula Martinez, PhD

Principal Investigator

Huntsman Cancer Institute

Eligibility Criteria

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

I am a smoker diagnosed with certain cancer types within the last 6 months.

Able to read/write English

Able to give informed consent

Exclusion Criteria

I am not a male with breast cancer.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

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]

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]

References

1. Germany 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. [2022]

2. England 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. [2022]

3. England 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. [2021]

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

Web-based self-management intervention for patients with cancer: A meta-analysis and systematic review. [2022]

5. Australia 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. [2020]

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

Depression burden, self-help interventions, and side effect experience in women receiving treatment for breast cancer. [2022]

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

The efficacy of computer-tailored smoking cessation material as a supplement to nicotine polacrilex gum therapy. [2022]

8. England 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. [2023]

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

The impact of tailored self-help smoking cessation guides on young mothers. [2019]

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

Smoking relapse-prevention intervention for cancer patients: Study design and baseline data from the surviving SmokeFree randomized controlled trial. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Effectiveness of smoking cessation interventions among persons with cancer: A systematic review. [2023]