Cystic Fibrosis (CF)NCT06606457
PACE CF, a 3-session Mind-body Pain Management Program for Adults With Cystic Fibrosis
A study testing Pain Acknowledgment Coping and Empowerment in CF (PACE CF) in people with Cystic Fibrosis (CF) and Pain Management, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis (CF), Pain Management
- What is being tested?
- Pain Acknowledgment Coping and Empowerment in CF (PACE CF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 9 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of CF;
- age > 18 years;
- report of pain affecting them at least moderately (score ≥ 2) on the IPOS item;
- pain lasting at least one month;
- English-speaking;
- participant willing and able to give informed consent.
Who cannot join
- Presenting an acute safety risk to self or others at baseline. Participants will not be excluded for the following reasons:
- CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT;
- Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions;
- psychosocial treatments (with the exception of another formal CBT for pain) or psychopharmacologic treatments at baseline. All concomitant psychosocial and pain-directed treatments will be tracked and considered in analysis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults With CF
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).
Read more
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.
Read the detailed description
This study is a multi-center collaboration of a psychological approach to pain treatment in CF. This is the first study to elicit input from the CF community and CF care team members to develop a brief, focused psychological treatment for pain in adults with CF (MGB IRB exempt protocol# 2022P003370). Utilizing the development phase of the grant (protocol# 2022P003370), the investigators developed a brief (3-session) structured intervention manual and patient workbook based on CF community feedback (PACE CF). The intervention will be highly accessible, delivered by a member of the CF care team via telehealth in both inpatient and outpatient settings. The workbook will provide education and resources for patients and reinforce skill practice. Resources will facilitate future training and dissemination, standardization, and evaluation of feasibility, acceptability, and efficacy of the intervention in a larger trial.
The PACE CF intervention integrates the well-established science of behavioral pain management with CF-specific content drawn from feedback from community stakeholders to develop an intervention specific to pain in CF. The investigators anticipate that integration of this intervention into the existing CF model of care will positively impact people with CF by increasing access to best practices in pain treatment, while minimizing additional cost and burden of care.
- Conditions
- Cystic Fibrosis (CF), Pain Management
- Being tested
- Pain Acknowledgment Coping and Empowerment in CF (PACE CF)
- Medical subject headings
- Cystic Fibrosis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Acknowledgment Coping and Empowerment in CF (PACE CF)Behavioural
The Pain Acknowledgment Coping and Empowerment in CF (PACE CF) program is a newly developed 3-session mind-body pain management intervention for adults with cystic fibrosis (CF), developed with CF community input. The sessions are delivered by the the CF care team psychologist. Each session will teach mind-body strategies to increase comfort and reduce the impact of pain on the participant\'s life. These strategies include understanding pain in CF from a mind-body perspective, learning relaxation and mindfulness-based skills, identifying and practicing individualized cognitive and behavioral strategies that improve comfort and well-being, and discussing communication skills that empower people living with CF and pain. Participants will receive a workbook that will provide related education and resources and reinforce skill practice.
| Study group | Role | What they receive |
|---|---|---|
| PACE CF Intervention | Experimental | 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. Receives: Behavioral: Pain Acknowledgment Coping and Empowerment in CF (PACE CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability - measured by treatment acceptability interview
During visit 5, post-intervention, participants will be asked to complete a brief qualitative interview conducted by a research coordinator regarding treatment acceptability that will be recorded. Interviews will be qualitatively coded utilizing content analysis to summarize feedback regarding intervention acceptability.
Measured: End of intervention, up to 2 months
Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)
Feedback on the intervention will be obtained from pilot subjects at both sites to assess acceptability of the pain management program.
At the end of visit 4, after the participant has completed the PACE CF program, participants will complete the Client Satisfaction Questionnaire (CSQ), an 8-item empirically-derived, validated, self-report measure assessing patient satisfaction with health services, rated on a 4-point scale from 1= lowest to 4 = highest satisfaction. The scale has a minimum score of 0, maximum score of 32, with higher scores indicating greater satisfaction.
Measured: End of intervention, up to 2 months
Feasibility - participant attrition during the intervention period.
Completion rates will be a key indicator of feasibility. Completion rate will be calculated as the percentage of intervention sessions completed out of the total number of possible sessions (the intervention is 3 sessions) among those enrolled.
Measured: From date of baseline assessment to completion of intervention, up to 2 months
Secondary outcomes (8)
Change in pain catastrophizing, measured by the Coping Strategies Questionnaire (CSQ-CAT)
This construct will be assessed using the 6-item catastrophizing scale from the Coping Strategies Questionnaire (CSQ-CAT). The catastrophizing scale score ranges from 0 to 36 with higher scores indicating greater pain catastrophizing.
Measured: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 \"not at all\" to 3 \";nearly every day\"; with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively. Higher scores indicate greater clinical severity of depressive symptoms.
Measured: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
The Generalized Anxiety Disorder scale (GAD-7) is a 7-item measure of symptoms of anxiety, rated on a Likert scale from 0 \"not at all\" to 3, \"nearly every day\", with total scores ranging 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety. Higher scores indicate greater clinical severity of anxiety symptoms.
Measured: From baseline assessment to post-intervention assessment, up to 2 months
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The Cystic Fibrosis Questionnaire-Revised (CFQ-R) is a well-established measure of health-related quality of life for people with CF that has been validated in a national, multicenter longitudinal study, demonstrating consistent associations with health outcomes in CF. It consists of 12 scales measuring physical HrQoL (e.g., physical functioning, eating disturbances) or psychosocial HrQoL (e.g., treatment burden, emotional functioning). Each of the 12 scales yield standardized scores ranging from 0 to 100 with higher scores indicating greater health-related quality of life.
Measured: From baseline assessment to post-intervention assessment, up to 2 months
Change in sleep quality, measured by the PROMIS Sleep Disturbance Scale short form
The PROMIS Sleep Disturbance Scale short form (PROMIS SF v1.0 - Sleep Disturbance 6a) is a 6-item validated scale of self-reported perception of sleep quality and disturbance over 7 days. Each item has a 5-point response option. Raw scores range from 6 to 30 and are converted to T-scores, with higher scores indicating greater sleep disturbance.
Measured: From baseline assessment to post-intervention assessment, up to 2 months
Change in pain intensity, measured by the PROMIS(r) Pain Intensity Instrument
The PROMIS(r) Pain Intensity Instrument (PROMIS Scale v2.0 - Pain Intensity 3a) is a 3- question self-report assessment of pain intensity on a scale from 1 "had no pain" to 5 "very severe." The first 2 questions utilize a 7-day recall and the last question rates pain "right now". Raw summary scores range from 3 to 15, and convert to T-scores, with higher scores indicating greater pain intensity.
Measured: From date of baseline assessment to date of post-intervention, up to 2 months
Change in pain interference, measured by the PROMIS(r) Pain Interference Scale adult short form
The PROMIS(r) Pain Interference Adult Short Form (6 items on a 5-point Likert Scale) measures self-reported consequences of pain on aspects of a person's life. Raw summary scores range from 4 to 20 and convert to T-scores, with higher scores indicating greater pain interference.
Measured: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Coping Self-Efficacy as measured by the Cystic Fibrosis Coping Self-Efficacy Scale (CF-CSE)
The Cystic Fibrosis Coping Self-Efficacy Scale was developed by investigators with CF community input. It is a 21-item measure with items rated on a 10-pt scale from "very uncertain" to "very certain," which asks participants to rate their certainty with being able to use a variety of skills and strategies to cope with stress. Some of these strategies reflect core components of CBT; some are specific to coping with CF; many will be targeted in the proposed pain management intervention. The CF Coping Self Efficacy measure contains four subscales: Acceptance/Self-Compassion (4 items), Cognitive Coping/Self-Awareness (8 items), Active Stress Management (4 items) , and Coping with Daily Self-Care Demands (5 items). Higher scores indicated greater coping self-efficacy in each domain of coping skills.
Measured: From baseline assessment to post-intervention assessment, up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start10 Sep 2024
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center
- Responsible party
- Principal investigator, Deborah Friedman, Massachusetts General Hospital
- Investigators
- Amanda Bruce, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606457
- Sponsor's protocol ID
- 2024P001312
- Status last verified
- Dec 2025
- First submitted
- 10 Sep 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study utilizes a small sample and collects mixed method data which may make it difficult to protect the privacy of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults With CF
- ClinicalTrials.gov ID
- NCT06606457
- Acronym / sponsor ID
- 2024P001312
- Conditions
- Cystic Fibrosis (CF), Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multi-center collaboration of a psychological approach to pain treatment in CF. This is the first study to elicit input from the CF community and CF care team members to develop a brief, focused psychological treatment for pain in adults with CF (MGB IRB exempt protocol# 2022P003370). Utilizing the development phase of the grant (protocol# 2022P003370), the investigators developed a brief (3-session) structured intervention manual and patient workbook based on CF community feedback (PACE CF). The intervention will be highly accessible, delivered by a member of the CF care team via telehealth in both inpatient and outpatient settings. The workbook will provide education and resources for patients and reinforce skill practice. Resources will facilitate future training and dissemination, standardization, and evaluation of feasibility, acceptability, and efficacy of the intervention in a larger trial.
The PACE CF intervention integrates the well-established science of behavioral pain management with CF-specific content drawn from feedback from community stakeholders to develop an intervention specific to pain in CF. The investigators anticipate that integration of this intervention into the existing CF model of care will positively impact people with CF by increasing access to best practices in pain treatment, while minimizing additional cost and burden of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PACE CF Intervention | Experimental | Behavioral: Pain Acknowledgment Coping and Empowerment in CF (PACE CF)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosis of CF;
- age > 18 years;
- report of pain affecting them at least moderately (score ≥ 2) on the IPOS item;
- pain lasting at least one month;
- English-speaking;
Key exclusion criteria (4 listed)
- Presenting an acute safety risk to self or others at baseline. Participants will not be excluded for the following reasons:
- CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT;
- Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions;
- psychosocial treatments (with the exception of another formal CBT for pain) or psychopharmacologic treatments at baseline. All concomitant psychosocial and pain-directed treatments will be tracked and considered in analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Acknowledgment Coping and Empowerment in CF (PACE CF)The Pain Acknowledgment Coping and Empowerment in CF (PACE CF) program is a newly developed 3-session mind-body pain management intervention for adults with cystic fibrosis (CF), developed with CF community input. The sessions are delivered by the the CF care team psychologist. Each session will teach mind-body strategies to increase comfort and reduce the impact of pain on the participant\'s life. These strategies include understanding pain in CF from a mind-body perspective, learning relaxation and mindfulness-based skills, identifying and practicing individualized cognitive and behavioral strategies that improve comfort and well-being, and discussing communication skills that empower people living with CF and pain. Participants will receive a workbook that will provide related education and resources and reinforce skill practice. | Behavioural | PACE CF Intervention |
Primary outcome
Acceptability - measured by treatment acceptability interview
Time frame: End of intervention, up to 2 months
During visit 5, post-intervention, participants will be asked to complete a brief qualitative interview conducted by a research coordinator regarding treatment acceptability that will be recorded. Interviews will be qualitatively coded utilizing content analysis to summarize feedback regarding intervention acceptability.
Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: End of intervention, up to 2 months
Feedback on the intervention will be obtained from pilot subjects at both sites to assess acceptability of the pain management program. At the end of visit 4, after the participant has completed the PACE CF program, participants will complete the Client Satisfaction Questionnaire (CSQ), an 8-item empirically-derived, validated, self-report measure assessing patient satisfaction with health services, rated on a 4-point scale from 1= lowest to 4 = highest satisfaction. The scale has a minimum score of 0, maximum score of 32, with higher scores indicating greater satisfaction.
Feasibility - participant attrition during the intervention period.
Time frame: From date of baseline assessment to completion of intervention, up to 2 months
Completion rates will be a key indicator of feasibility. Completion rate will be calculated as the percentage of intervention sessions completed out of the total number of possible sessions (the intervention is 3 sessions) among those enrolled.
8 secondary outcomes
Change in pain catastrophizing, measured by the Coping Strategies Questionnaire (CSQ-CAT)
Time frame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
Time frame: From baseline assessment to post-intervention assessment, up to 2 months
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: From baseline assessment to post-intervention assessment, up to 2 months
Change in sleep quality, measured by the PROMIS Sleep Disturbance Scale short form
Time frame: From baseline assessment to post-intervention assessment, up to 2 months
Change in pain intensity, measured by the PROMIS(r) Pain Intensity Instrument
Time frame: From date of baseline assessment to date of post-intervention, up to 2 months
Change in pain interference, measured by the PROMIS(r) Pain Interference Scale adult short form
Time frame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
Coping Self-Efficacy as measured by the Cystic Fibrosis Coping Self-Efficacy Scale (CF-CSE)
Time frame: From baseline assessment to post-intervention assessment, up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No. The study utilizes a small sample and collects mixed method data which may make it difficult to protect the privacy of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Bruce, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Acknowledgment Coping and Empowerment in CF (PACE CF) in people with Cystic Fibrosis (CF) and Pain Management, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability - measured by treatment acceptability interview (time frame: End of intervention, up to 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.