Support Groups for Bronchiectasis

(BronchConnect Trial)

Overseen by Shoshana Zha, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Cystic fibrosis, Pulmonary fibrosis, Transplant, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

BronchConnect is a prospective trial to investigate the impact of support groups on health care related quality of life in those with noncystic fibrosis bronchiectasis (NCFBE). It has been well demonstrated that participation in patient support groups improves quality of life in those who suffer from interstitial lung disease and chronic obstructive pulmonary disease, but the impact is largely unknown for those who live with NCFBE, a chronic lung disease with rising prevalence with no targeted FDA-approved therapy. NCFBE causes chronic cough, dyspnea, recurrent infections, and leads to anxiety and uncertainty. This study seeks to evaluate the impact of a virtual patient support group for patients with NCFBE through questionnaires to assess change of quality of life and anxiety, and exacerbation rates through clinical assessment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on support groups rather than medication changes.

What data supports the effectiveness of the treatment Support Group for bronchiectasis?

Support groups, as a form of self-management, can help people with bronchiectasis manage their condition better and improve their quality of life. Similar self-management strategies have been beneficial for other lung diseases like asthma and COPD (chronic obstructive pulmonary disease). ^{1 2 3 4 5}

Is participating in a support group generally safe for people?

The research does not provide specific safety data about support groups for bronchiectasis or other conditions, but support groups are generally considered safe as they involve peer support and sharing experiences rather than medical interventions. ^{6 7 8 9 10}

How do support groups for bronchiectasis differ from other treatments?

Support groups for bronchiectasis are unique because they focus on self-management and empowering patients to manage their condition, which can improve quality of life. Unlike traditional treatments that may involve medication or physical therapies, support groups provide a platform for patients to share experiences and strategies, potentially reducing the burden of symptoms and healthcare utilization. ^{1 2 11 12 13}

Research Team

Shoshana Zha, MD, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults with non-cystic fibrosis bronchiectasis confirmed by a CT chest scan, where it's the main lung issue. Participants must be able to give informed consent and speak English well enough to have full conversations.

Inclusion Criteria

Diagnosis of bronchiectasis on computed tomography (CT) chest scan

My main lung problem is bronchiectasis.

Exclusion Criteria

I have received an organ transplant.

I am under 18 years old.

I have cystic fibrosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and assessments for severity of disease, comorbidities, and exacerbations

1-2 weeks

Intervention

Participants attend virtual support group sessions and multidisciplinary educational programs

12 months

Regular virtual sessions

Follow-up

Participants are monitored for changes in quality of life, anxiety, and exacerbation rates through questionnaires and clinical assessments

12 months

Treatment Details

Interventions

• Support Group (Behavioral Intervention)

Trial Overview The study examines how joining a virtual support group affects life quality and anxiety in people with NCFBE. It measures changes through questionnaires and checks if their condition gets worse less often.

Participant Groups

Group I: Support Group Experimental Treatment 1 Intervention

Non-randomized pre-post trial, in which each participant will serve as their own control. Participants will be recruited from a bronchiectasis specialty clinic.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Findings from Research

Self-management programs for bronchiectasis, particularly those combining education with action planning, airway clearance techniques, and exercise, can significantly enhance patients' self-efficacy and quality of life, as identified through a systematic review of eight studies.

The effectiveness of these programs is influenced by patient characteristics and the collaborative relationship between patients and healthcare professionals, highlighting the importance of personalized approaches in managing bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management programmes for adult patients with bronchiectasis: a systematic review and realist synthesis. Tsang, A., Lynes, D., McKenzie, H., et al.[2023]

In a study of 116 patients with bronchiectasis followed for an average of 14 years, the overall prognosis was good, with 30% showing improvement in symptoms and 77% maintaining a good work record despite the condition.

However, 7% of patients experienced severe disability, and social issues persisted, with many spouses reporting challenges related to the patient's cough and sexual life, highlighting the need for ongoing support for affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Present outlook in bronchiectasis: clinical and social study and review of factors influencing prognosis. Ellis, DA., Thornley, PE., Wightman, AJ., et al.[2019]

In a study of 92 patients with bronchiectasis who underwent surgical resection, surgery resulted in a low mortality rate of 1% and a morbidity rate of 16%, indicating it is a safe option for treatment.

After surgery, 84% of patients were asymptomatic, demonstrating that surgical intervention can lead to significant clinical improvement in selected patients with bronchiectasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical management of bronchiectasis: the indications and outcomes. Gursoy, S., Ozturk, AA., Ucvet, A., et al.[2021]

A study involving adults with bronchiectasis revealed that treatment adherence is influenced by patients' beliefs about their treatment, practical management aspects, trust in healthcare professionals, and their acceptance of the disease.

The research developed a conceptual model showing that adherence decisions are shaped by a balance of individual barriers and motivating factors, suggesting that personalized strategies could improve adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'All illness is personal to that individual': a qualitative study of patients' perspectives on treatment adherence in bronchiectasis. McCullough, AR., Tunney, MM., Elborn, JS., et al.[2023]

Industry-sponsored program reports in the FDA Adverse Event Reporting System were associated with a higher percentage of serious outcomes compared to non-industry-sponsored reports (58.8% vs. 51.4%), indicating they may capture more severe adverse events.

Despite containing more data elements, the overall usefulness of industry-sponsored and non-industry-sponsored reports for safety signal detection was similar, with only a small percentage of reports (4% for non-industry and 6.2% for industry) identifying serious, unlabeled adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. Harinstein, L., Kalra, D., Kortepeter, CM., et al.[2020]

In a study involving 3106 hospitalized children, the Patient and Family Centered I-PASS intervention significantly reduced adverse events (AEs) in children with complex chronic conditions (CCCs) by 50%.

However, the intervention did not show a statistically significant impact on AE rates for children without CCCs, indicating that the benefits of PFC I-PASS may be more pronounced in those with more complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions. Kuzma, N., Khan, A., Rickey, L., et al.[2023]

A systematic review of 119 studies on stage III non-small cell lung cancer (NSCLC) revealed that adverse events (AEs) were inconsistently reported, with 94.12% of studies documenting grade 3 AEs and 92.44% reporting grade 4 AEs, but only 53.78% and 63.03% for grade 1 and 2 AEs, respectively.

In studies involving surgical procedures, AEs were often underreported, with 10 out of 31 surgical treatment arms not mentioning any AEs, highlighting a significant gap in patient-relevant information that could impact treatment decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. Iseli, T., Berghmans, T., Glatzer, M., et al.[2022]

In a study of 77 patients with bronchiectasis not due to cystic fibrosis, inhaled budesonide did not show significant improvements in lung function compared to placebo over six months, indicating limited efficacy in this regard.

However, the budesonide group exhibited a tendency towards improvement in symptoms and quality of life, along with a significant reduction in sputum eosinophils, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Budesonide efficacy and safety in patients with bronchiectasis not due to cystic fibrosis. Hernando, R., Drobnic, ME., Cruz, MJ., et al.[2022]

Bronchiectasis (BE) is a growing global health issue characterized by airway dilation and persistent infections, leading to significant impacts on patients' quality of life, yet treatment guidelines are based on limited high-quality evidence.

Experts identified critical unmet needs in BE management, including the need for better pharmacological treatments to clear airways and reduce inflammation, improved methods for classifying patients, and the establishment of clinical endpoints for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. Flume, PA., Basavaraj, A., Garcia, B., et al.[2023]

In a study of 95 adult patients with bronchiectasis, frequent exacerbations (≥3 per year) and high disease severity scores were identified as major risk factors for poor quality of life, indicating that managing exacerbations could improve patient outcomes.

The study found that physical capacity, as measured by the modified Medical Research Council dyspnoea scale, was negatively correlated with quality of life, suggesting that addressing dyspnoea and disease severity may enhance the overall well-being of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In bronchiectasis, poor physical capacity correlates with poor quality of life. Mäntylä, J., Mazur, W., Törölä, T., et al.[2022]

References

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

Self-management for bronchiectasis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Self-management programmes for adult patients with bronchiectasis: a systematic review and realist synthesis. [2023]

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

Present outlook in bronchiectasis: clinical and social study and review of factors influencing prognosis. [2019]

4. Japan pubmed.ncbi.nlm.nih.gov

Surgical management of bronchiectasis: the indications and outcomes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

'All illness is personal to that individual': a qualitative study of patients' perspectives on treatment adherence in bronchiectasis. [2023]

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

Evaluation of'the Buddy Study', a peer support program for second victims in healthcare: a survey in two Danish hospital departments. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance. [2020]

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

Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions. [2023]

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

Unintended consequences of evolution of the Common Terminology Criteria for Adverse Events. [2023]

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

Adverse events reporting in stage III NSCLC trials investigating surgery and radiotherapy. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Budesonide efficacy and safety in patients with bronchiectasis not due to cystic fibrosis. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Towards development of evidence to inform recommendations for the evaluation and management of bronchiectasis. [2023]

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

In bronchiectasis, poor physical capacity correlates with poor quality of life. [2022]