Veteran Social Support for Smoking Cessation

(VAntage Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Steven S. Fu, MD MSCE

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Must not be taking: Cessation medications

Disqualifiers: No phone contact, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the quitting process once the Veteran is ready to quit smoking sometime in the future. Study staff will assess how much or how little social support during the Veteran's quitting process is helpful to the Veteran. This information will help us come up with new ways to help Veterans quit smoking that are better tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used cessation medications or a stop smoking program in the past 3 months, you are not eligible to participate.

What data supports the effectiveness of the treatment Veteran Social Support for Smoking Cessation?

Research shows that self-help smoking cessation materials can lead to up to 20% of people quitting smoking after a year. Additionally, social support and minimal personal contact can enhance the effectiveness of these materials. ^{1 2 3 4 5}

Is the Veteran Social Support for Smoking Cessation treatment generally safe for humans?

The research articles provided do not contain specific safety data for the Veteran Social Support for Smoking Cessation treatment or its related interventions. Therefore, no relevant safety information is available from these sources. ^{6 7 8 9 10}

How does the Veteran Social Support for Smoking Cessation treatment differ from other smoking cessation treatments?

This treatment is unique because it focuses on leveraging social support from nonsmokers to encourage veterans to use existing smoking cessation services, like quitlines, which are often underutilized. Unlike traditional methods that rely on medications or self-help materials, this approach emphasizes the role of personal encouragement and motivation from a support person to help veterans quit smoking. ^{3 5 11 12 13}

Research Team

Steven S. Fu, MD MSCE

Principal Investigator

Minneapolis VA Health Care System, Minneapolis, MN

Eligibility Criteria

This trial is for Veterans who smoke cigarettes and have a support person willing to help them quit. The Veteran must be using cigarettes primarily if they use other tobacco products, and should have smoked at least once in the past month. Their chosen support person needs to be an adult they're in contact with at least three times a week.

Inclusion Criteria

Veteran must have smoked at least 1 cigarette over the past 30 days, even a puff

If using other tobacco or nicotine products, cigarettes must be the main product used

Must be able to identify one adult family member or friend with whom they have contact at least 3 times per week who will enroll as the Veteran Support Person

Exclusion Criteria

Veteran must have used cessation medications or a stop smoking program within the past 3 months

I have a working phone number.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive written materials and, for the intervention group, a 1-call coaching session to support smoking cessation

6 months

1 call (15-25 minutes) for intervention group

Follow-up

Participants are monitored for smoking abstinence and use of cessation treatments

6 months

Assessments at baseline, 3 months, and 6 months

Treatment Details

Interventions

• SP written materials (Behavioral Intervention)
• Support Person Coaching Call (Behavioral Intervention)
• Written Smoking Cessation Materials (Behavioral Intervention)

Trial Overview The study tests whether having a support person receiving coaching calls and written materials can enhance smoking cessation efforts among Veterans. It aims to determine how social support affects the quitting process, potentially leading to new tailored cessation strategies.

Participant Groups

Group I: Support Person Coaching Call and Written Materials Experimental Treatment 3 Interventions

Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Support person participants assigned to the intervention group will additionally receive a 1-call coaching session about 15-25 minutes in duration on how to support their Veteran smoker. The coaching session will be delivered by research staff by phone or video call. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.

Group II: Written Materials Only Active Control 2 Interventions

Support persons will receive written material resources on support strategies to stop smoking, and resources on how to stop smoking. Veteran smokers will receive written smoking cessation resource and referral information for VHA and non-VHA EBCT options.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

The study highlights the effectiveness of a 15-30 minute phone intervention delivered by tobacco cessation coaches, aimed at helping family members support smokers in quitting, based on analysis of 193 recorded sessions.

Key barriers faced by support persons, such as uncertainty in how to approach the smoker and the smoker's readiness to quit, were identified, along with coaches' strategies to address these challenges, providing valuable insights for clinicians and providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skill Sets for Family Members and Friends to Help Motivate a Smoker to Seek Treatment: Research to Practice. Brockman, TA., Patten, CA., Lukowski, A.[2020]

A pilot study at Georgetown University showed that a 6-hour training program for advanced practice nursing students significantly improved their knowledge and confidence in helping patients quit tobacco.

The 'Rx for Change' curriculum demonstrates the importance of targeted training for healthcare providers to effectively support tobacco cessation efforts among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Rx for Change tobacco curriculum in advanced practice nursing education. Kelley, FJ., Heath, J., Crowell, N.[2019]

Smoking-cessation campaigns using printed self-help materials can lead to abstinence rates of up to 20% after 12 months, highlighting their potential effectiveness.

While personalized materials do not improve cessation rates, incorporating social support and minimal personal contact can enhance the likelihood of quitting, indicating the importance of community and support in smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-help smoking cessation materials. Brown, SL., Owen, N.[2019]

An empathic and personalized smoking cessation intervention program, with extended assistance and follow-up, is the most effective way to prevent serious health issues like heart disease and cancer in tobacco users, aiming for complete cessation rather than just reduction.

Current guidelines for smoking cessation, based on the Transtheoretical Model and the 'Five A's' (Ask, Advise, Assess, Assist, Arrange), provide a structured approach for clinicians, but these interventions are often underutilized due to a lack of training and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco cessation in primary care: maximizing intervention strategies. Anczak, JD., Nogler, RA.[2022]

Every smoker should be offered smoking cessation treatment at every healthcare visit, as even brief interventions can be effective in helping individuals quit smoking.

The most effective smoking cessation strategies include nicotine replacement therapy, clinician-delivered social support, and skills training, with more intensive treatments leading to better long-term success in quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: information for specialists. Agency for Health Care Policy and Research. [2015]

In a study involving 231 outpatients, staff-initiated telephone interviews effectively captured reliable reports of new or unusual symptoms after patients were prescribed medications, demonstrating the potential of this method for monitoring adverse drug reactions (ADRs).

The approach successfully identified known ADRs associated with tricyclic antidepressants and antibiotics, suggesting that structured follow-up can enhance postmarketing surveillance of drug safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New approaches to postmarketing surveillance. Fisher, S., Bryant, SG., Kluge, RM.[2019]

This systematic review aims to evaluate the clinical efficacy and safety of Chinese herbal medicine (CHM) compared to placebo in treating stable chronic obstructive pulmonary disease (COPD), using data from multiple databases and including randomized controlled trials.

The primary outcomes will focus on quality of life, symptom scores, and exacerbation frequency, while secondary outcomes will assess lung function and adverse events, providing a comprehensive evaluation of CHM's effectiveness and safety for COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese Herbal Medicine Versus Placebo for the Treatment Of Chronic Obstructive Pulmonary Disease: A Protocol of Systematic Review and Meta-analysis. Xiong, C., Li, Y., Zeng, Y., et al.[2023]

Over 12% of the U.S. population uses herbal therapies annually, leading to significant out-of-pocket expenses, particularly among patients with chronic diseases, highlighting the need for better education among healthcare providers regarding the safety of these therapies.

There is a pressing need for improved post-market surveillance of dietary supplements to monitor safety, identify harmful products, and study their mechanisms of action, as current research has primarily focused on efficacy rather than safety, leading to potential risks for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety assurances for dietary supplements policy issues and new research paradigms. Basch, EM., Servoss, JC., Tedrow, UB.[2008]

A pilot study involving 1021 users of ibuprofen from community pharmacies in Scotland and England revealed a significant increase in gastrointestinal symptoms after use, highlighting potential safety concerns with non-prescription medications.

The study suggests that community pharmacies could play a crucial role in monitoring adverse events related to non-prescription medicines, indicating a need for improved pharmacovigilance practices to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK. Layton, D., Sinclair, HK., Bond, CM., et al.[2015]

A study analyzing the Partner Interaction Questionnaire (PIQ) responses from smokers in a cessation program identified four distinct factors of social support, which were more effective in predicting smoking cessation than the traditional two-factor model.

Using a more detailed approach to measure social support can enhance our understanding of its role in helping individuals quit smoking, suggesting that tailored support strategies may be more beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between social support and smoking cessation: revisiting an established measure to improve prediction. Burns, RJ., Rothman, AJ., Fu, SS., et al.[2021]

The pilot study successfully recruited 30 support person-smoker dyads from diverse, low-income communities, indicating that outreach methods were effective, particularly in-person recruitment.

While the intervention was generally well-received by support persons, only 7% of smokers utilized quitline services, and only 13% achieved biochemically verified smoking abstinence at 3 months, suggesting that further adaptations are necessary to improve engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support person interventions to increase use of quitline services among racially diverse low-income smokers: A pilot study. Patten, CA., Fu, S., Vickerman, K., et al.[2023]

An intervention designed for nonsmoking support persons to encourage smokers to use the QUITPLAN Helpline was developed and piloted, showing high compliance with 93% of support people completing all sessions.

The intervention was well-received, with 77% of support persons finding it helpful, and it successfully led to five smokers calling the helpline, indicating its potential effectiveness in promoting smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support person intervention to promote smoker utilization of the QUITPLAN Helpline. Patten, CA., Smith, CM., Brockman, TA., et al.[2022]

References

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

Skill Sets for Family Members and Friends to Help Motivate a Smoker to Seek Treatment: Research to Practice. [2020]

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

Using the Rx for Change tobacco curriculum in advanced practice nursing education. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Self-help smoking cessation materials. [2019]

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

Tobacco cessation in primary care: maximizing intervention strategies. [2022]

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

Smoking cessation: information for specialists. Agency for Health Care Policy and Research. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

New approaches to postmarketing surveillance. [2019]

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

Chinese Herbal Medicine Versus Placebo for the Treatment Of Chronic Obstructive Pulmonary Disease: A Protocol of Systematic Review and Meta-analysis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety assurances for dietary supplements policy issues and new research paradigms. [2008]

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

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Pharmacovigilance of over-the-counter products based in community pharmacy: methodological issues from pilot work conducted in Hampshire and Grampian, UK. [2015]

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

The relation between social support and smoking cessation: revisiting an established measure to improve prediction. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Support person interventions to increase use of quitline services among racially diverse low-income smokers: A pilot study. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Support person intervention to promote smoker utilization of the QUITPLAN Helpline. [2022]