Mind-Body Pain Management for Cystic Fibrosis

Overseen By Deborah Friedman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Acute safety risk, others

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new way to manage pain for adults with cystic fibrosis (CF) using a mind-body approach instead of medication. Participants will engage in a three-session program conducted through telehealth, focusing on coping strategies and empowerment. This program is called Pain Acknowledgment Coping and Empowerment in CF (PACE CF). The study will assess whether this approach reduces pain's impact on daily life and improves overall well-being. Suitable candidates for this trial are English-speaking adults with CF who have experienced moderate pain for at least one month. As an unphased trial, this study offers participants the opportunity to contribute to innovative pain management strategies and potentially enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, it encourages a multi-component approach to pain management, which can include your existing pain medications.

What prior data suggests that the PACE CF intervention is safe for adults with cystic fibrosis?

Research shows that mind-body treatments like PACE CF are usually easy for people to handle. Since PACE CF doesn't involve medication, it carries a lower risk of side effects compared to drug treatments. Participants in similar programs often report few or no negative effects, suggesting that PACE CF should be safe for adults with cystic fibrosis. However, because this program is new, researchers are still collecting direct data on its safety in humans. The goal is to determine how effectively it manages pain without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PACE CF program because it offers a fresh approach to pain management in cystic fibrosis, focusing on mind-body techniques rather than medication. While traditional treatments often involve painkillers or physical therapies, PACE CF empowers patients through psychological strategies, helping them acknowledge and cope with pain in a healthier way. This approach could potentially reduce the reliance on medications, leading to fewer side effects and a more holistic management of pain.

What evidence suggests that the PACE CF intervention is effective for managing pain in cystic fibrosis?

Research has shown that mind-body techniques can help manage pain in people with cystic fibrosis (CF). In this trial, participants will engage in the PACE CF program, a new method designed specifically for adults with CF. Early results suggest that these techniques can lessen pain and improve coping. While specific data on PACE CF is still being gathered, early signs are encouraging for effective pain management. This method focuses on recognizing pain and equipping patients with tools to handle it better, potentially improving their quality of life and reducing the need for pain medication. ^{1 2 3 4 6}

Who Is on the Research Team?

Amanda Bruce, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for adults with cystic fibrosis who experience pain. Participants must be able to attend three telehealth sessions and may be at home or hospitalized. Specific eligibility criteria are not provided, but typically include factors like age range, disease severity, and ability to comply with study requirements.

Inclusion Criteria

I experience moderate to severe pain.

Participant willing and able to give informed consent

I am older than 18 years.

Exclusion Criteria

Presenting an acute safety risk to self or others at baseline

I am taking part in treatments for my pain, including medications.

I have cystic fibrosis or have had a lung/liver transplant but can still participate in therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete a 3-session mind-body pain management program (PACE CF) via telehealth

3 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of quality of life and pain management

up to 2 months

What Are the Treatments Tested in This Trial?

Interventions

• Pain Acknowledgment Coping and Empowerment in CF (PACE CF)

Trial Overview

The PACE CF program is being tested; it's a non-medication mind-body intervention designed for cystic fibrosis patients' pain management. The study aims to assess its feasibility, acceptability, and preliminary impact on pain interference in daily life.

How Is the Trial Designed?

Group I: PACE CF Intervention Experimental Treatment 1 Intervention

Participants will complete an baseline series of questionnaires, and then meet with the psychologist on their cystic fibrosis care team for 3 weekly meetings to complete the PACE CF program and learn mind-body strategies for pain management. Following completion of the program, they will complete a second assessment that includes another set of questionnaires and a brief qualitative interview to provide feedback about the program.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Kansas Medical Center

Collaborator

Trials

527

Recruited

181,000+

Published Research Related to This Trial

A survey of 123 cystic fibrosis patients revealed that 84% experience pain, with headache and abdominal pain being the most common types, indicating a significant symptom burden that may require better management strategies.

Breathlessness and cough were also prevalent, affecting 64% and 83% of participants respectively, with cough notably interfering with sleep for many, suggesting that sleep disturbances could be a key indicator of overall disease impact in cystic fibrosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and self-management of pain, dyspnea, and cough in cystic fibrosis. Stenekes, SJ., Hughes, A., Grégoire, MC., et al.[2011]

A survey of 336 cystic fibrosis stakeholders revealed that many believe palliative care (PC) is underutilized for individuals with CF, which could enhance their quality of life.

Respondents emphasized the importance of PC, especially for those considering lung transplants, indicating that PC services are critical for managing anxiety and discussing care goals, although some viewed PC and lung transplant as mutually exclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Practices, Beliefs, and Attitudes about Palliative Care among People with Cystic Fibrosis, Their Caregivers, and Clinicians: Results of a Content Analysis. Basile, M., Jojan, L., Hobler, MR., et al.[2022]

A study involving interviews with 7 children and young people with cystic fibrosis, along with their parents and healthcare professionals, developed a model showing that empowerment is crucial for 'thriving alongside CF' by fostering teamwork and encouraging self-advocacy.

The research highlights that feeling empowered allows children with CF to focus on being kids rather than just managing their condition, but concealing their illness can hinder this empowerment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thriving alongside cystic fibrosis: Developing a grounded theory of empowerment in children and young people with cystic fibrosis during key life transitions. Fairweather, NH., Jones, FW., Harris, SA., et al.[2021]

About half of the 18 cystic fibrosis patients surveyed reported experiencing daily pain episodes, with an average intensity in the moderate range, indicating a significant issue with pain management in this population.

Participants reported that pain significantly affected their ability to engage in recreation, work, and social activities, while they commonly used coping strategies like problem solving and acceptance to manage their pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain, coping, and disability in adolescents and young adults with cystic fibrosis: a Web-based study. Hubbard, PA., Broome, ME., Antia, LA.[2015]

A survey of 146 clinicians revealed that mental health, palliative care, and pain specialists are the most sought-after experts for managing the high symptom burden experienced by people living with cystic fibrosis (PLwCF).

Key barriers to effective symptom management include concerns about addiction to controlled substances, lack of trust among specialties, and limited access to affordable care, suggesting a need for interdisciplinary collaboration and the development of clinical care guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician perspectives on barriers and solutions to symptom management in cystic fibrosis. Smirnova, N., Trandel, ET., Dubin, E., et al.[2023]

Among 55 participants with cystic fibrosis (CF), 76% reported experiencing pain, which was also the most distressing symptom for 64% of them, highlighting a significant issue in symptom management.

Participants not on CFTR modulator therapy reported more distress from pain, indicating that those receiving standard treatments may have unmet needs for effective pain management and a desire for a multi-modal treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of unmet pain and symptom management needs in adults with cystic fibrosis. Dubin, E., Lowers, J., Dellon, EP., et al.[2023]

Empowerment in children and young people with cystic fibrosis (CF) is enhanced through supportive relationships and respectful communication with family, friends, and healthcare teams, allowing them to feel heard and understood.

Barriers to empowerment include prejudices and assumptions about their capabilities, highlighting the need for developmentally appropriate information and opportunities for mastery in everyday activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to empowerment in children and young people with cystic fibrosis: a meta-synthesis of the qualitative literature. Fairweather, N., Jones, FW.[2023]

A significant majority (89%) of adolescents and young adults with cystic fibrosis reported distress before spirometry, and 67% experienced distress during the procedure, highlighting the emotional challenges associated with this common medical test.

The study found that higher acceptance of illness was linked to lower expectations of pain and fewer pain-related thoughts, suggesting that acceptance may help mitigate some psychological aspects of undergoing spirometry, although it did not reduce actual distress or pain experienced during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spirometry-related pain and distress in adolescents and young adults with cystic fibrosis: the role of acceptance. Casier, A., Goubert, L., Vervoort, T., et al.[2021]

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Even as many outcomes for people living with cystic fibrosis (PLwCF) improve, individuals still experience extensive symptom burdens.

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Addressing Pain in People Living With Cystic Fibrosis

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