Integrating Supportive Care in Cystic Fibrosis

Study Overview
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Brief Summary
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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
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As described above.

Official Title
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Integrating Supportive Care in Cystic Fibrosis: A Pilot Study

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Supportive Care Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Prisoners Females who are pregnant Prior receipt of specialist SC services Cognitive impairments Patients younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Experimental: Supportive Care Intervention<br>Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner. | Behavioral: Supportive Care Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 9 months (+/- 4 weeks) | 
| Acceptability of intervention | Measured by: proportion of participants who endorse the intervention as acceptable. | 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. | 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. | Up to 9 months (+/- 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Up to 9 months (+/- 4 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Cystic Fibrosis