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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Many people living with cystic fibrosis (CF) experience pain. However, pain is sometimes unrecognized and under-managed in people with CF. Both medication and non-medication interventions can be used to treat pain and ideally, there is a multicomponent management approach. The goal of this study is to pilot a new 3-session non-medication mind-body pain management intervention specifically designed for adults with cystic fibrosis (CF). The intervention is titled Pain Acknowledgement Coping and Empowerment in CF (PACE CF). PACE CF will be administered by a member of the CF care team via telehealth visits to participants at home or during a hospitalization. The aim of the study is to evaluate the feasibility and patient acceptability of the intervention as well as preliminary evidence of the impact of the intervention on pain and its interference in daily life. The study will also examine outcomes such as perceived coping, quality of life, symptoms of depression or anxiety, and use of prescribed pain medication, in an exploratory manner.

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 data supports the effectiveness of the treatment Pain Acknowledgment Coping and Empowerment in CF (PACE CF) for managing pain in cystic fibrosis?

The research highlights the importance of patient empowerment in managing the high treatment burden of cystic fibrosis, suggesting that empowering patients can be beneficial. Additionally, clinicians see value in non-drug approaches for symptom management, which aligns with the goals of PACE CF. ^{1 2 3 4 5}

How is the PACE CF treatment different from other treatments for cystic fibrosis?

The PACE CF treatment is unique because it focuses on mind-body techniques to manage pain in cystic fibrosis, emphasizing non-drug approaches like coping strategies and empowerment, which are not typically the focus of standard CF treatments that often rely on medications. ^{3 4 6 7 8}

Research Team

Amanda Bruce, PhD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

1. England 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. [2023]

2. England 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. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Clinician perspectives on barriers and solutions to symptom management in cystic fibrosis. [2023]

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

Pain, coping, and disability in adolescents and young adults with cystic fibrosis: a Web-based study. [2015]

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

Spirometry-related pain and distress in adolescents and young adults with cystic fibrosis: the role of acceptance. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence of unmet pain and symptom management needs in adults with cystic fibrosis. [2023]

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

Frequency and self-management of pain, dyspnea, and cough in cystic fibrosis. [2011]

8. United States 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. [2022]