Integrating Supportive Care in Cystic Fibrosis

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Supportive Care Intervention

Detailed Description

As described above.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; 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; Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.	Behavioral: Supportive Care Intervention; 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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization	The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Cystic Fibrosis Foundation
• Investigators: Principal Investigator: Dio Kavalieratos, PhD, Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh; Principal Investigator: Joseph Pilewski, MD, Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Actual): November 29, 2018
• Study Completion (Actual): October 7, 2019

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary Cystic Fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: IRB#: PRO14110168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.