Cystic FibrosisNCT02668575
Integrating Supportive Care in Cystic Fibrosis
A study testing Supportive Care Intervention in people with Cystic Fibrosis, run by University of Pittsburgh at 1 site in United States.
Trial summary
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Supportive Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2016to 7 Oct 2019
- 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
- Ability to comprehend English
- Advanced CF
- (Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
- Baseline non-invasive mechanical ventilation requirement
- ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
Who cannot join
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF. The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF. The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care. Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden. This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
Read the detailed description
As described above.
- Conditions
- Cystic Fibrosis
- Being tested
- Supportive Care Intervention
- Keywords
- Pulmonary Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Care InterventionBehavioural
Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis. Using a structured intervention manual, these visits will span 30-60 minutes each. Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience. Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center. |
| Supportive Care Intervention | Experimental | Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner. Receives: Behavioral: Supportive Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention
Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
Measured: Up to 9 months (+/- 4 weeks)
Acceptability of intervention
Measured by: proportion of participants who endorse the intervention as acceptable.
Measured: Up to 9 months (+/- 4 weeks)
Perceived effectiveness of intervention
Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
Measured: Up to 9 months (+/- 4 weeks)
Intervention fidelity
Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
Measured: Up to 9 months (+/- 4 weeks)
Secondary outcomes (5)
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Change in QOL from baseline as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) at 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
Measured: Up to 9 months (+/- 4 weeks)
Patient mood
Change in mood from baseline using the Hospital Anxiety and Depression Scale (HADS), reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
Measured: Up to 9 months (+/- 4 weeks)
Coping style
Change in coping style from baseline using the Brief COPE, reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
Measured: Up to 9 months (+/- 4 weeks)
Satisfaction with care
Change in satisfaction with care from baseline using the FAMCARE-P13, reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
Measured: Up to 9 months (+/- 4 weeks)
Symptom burden
Change in symptom burden from baseline using the Edmonton Symptom Assessment Scale (ESAS), reported at 0, 3, 6, 9 months. Due to the pilot nature of this trial, this measure will not be used to assess the efficacy of the intervention.
Measured: Up to 9 months (+/- 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study start2 Mar 2016
- Primary completion29 Nov 2018
- Study completion7 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Principal investigator, Dio Kavalieratos, PhD, University of Pittsburgh
- Investigators
- Dio Kavalieratos, PhD, Principal investigator, Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of PittsburghJoseph Pilewski, MD, Principal investigator, Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668575
- Sponsor's protocol ID
- IRB#: PRO14110168
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2016
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis. This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT02668575
- Acronym / sponsor ID
- IRB#: PRO14110168
- Conditions
- Cystic Fibrosis
- Keywords
- Pulmonary Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF. The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF. The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care. Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden. This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
Detailed description
As described above.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Patients randomized to the control arm of this study will continue to receive the standard of high-quality CF care provided to all patients at the UPMC CF Center. |
| Supportive Care Intervention | Experimental | Behavioral: Supportive Care InterventionPatients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to comprehend English
- Advanced CF
- (Any of the following criteria will be indicative of "Advanced CF")
- Baseline supplemental oxygen requirement
- FEV1 ≤ 50%
Key exclusion criteria (5 listed)
- Prisoners
- Females who are pregnant
- Prior receipt of specialist SC services
- Cognitive impairments
- Patients younger than 18 years of age
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 |
|---|---|---|
| Supportive Care InterventionPatients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis. Using a structured intervention manual, these visits will span 30-60 minutes each. Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience. Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider. | Behavioural | Supportive Care Intervention |
Primary outcome
Feasibility of intervention
Time frame: Up to 9 months (+/- 4 weeks)
Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
Acceptability of intervention
Time frame: Up to 9 months (+/- 4 weeks)
Measured by: proportion of participants who endorse the intervention as acceptable.
Perceived effectiveness of intervention
Time frame: Up to 9 months (+/- 4 weeks)
Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
Intervention fidelity
Time frame: Up to 9 months (+/- 4 weeks)
Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
5 secondary outcomes
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: Up to 9 months (+/- 4 weeks)
Patient mood
Time frame: Up to 9 months (+/- 4 weeks)
Coping style
Time frame: Up to 9 months (+/- 4 weeks)
Satisfaction with care
Time frame: Up to 9 months (+/- 4 weeks)
Symptom burden
Time frame: Up to 9 months (+/- 4 weeks)
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 18 Feb 2020.
- Individual participant dataSharing planned: Yes. It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis. This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
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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.
Dio Kavalieratos, PhD principal investigator
Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
Joseph Pilewski, MD principal investigator
Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Care Intervention in people with Cystic Fibrosis, run by University of Pittsburgh 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 7 inclusion and 5 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 18 Feb 2020. 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?
Feasibility of intervention (time frame: Up to 9 months (+/- 4 weeks)). The study lists 4 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 18 Feb 2020.