Clinical trial NCT02668575: Integrating Supportive Care in Cystic Fibrosis
Official title: Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Pulmonary Cystic Fibrosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2016-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of intervention
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Acceptability of intervention
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Perceived effectiveness of intervention
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Intervention fidelity
timeFrame: Up to 9 months (+/- 4 weeks)
Secondary outcomes:
measure: Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Patient mood
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Coping style
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Satisfaction with care
timeFrame: Up to 9 months (+/- 4 weeks)
measure: Symptom burden
timeFrame: Up to 9 months (+/- 4 weeks)
Other outcomes:
measure: Healthcare utilization
timeFrame: Up to 12 months
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh
name: Dio Kavalieratos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh
name: Joseph Pilewski, MD
role: PRINCIPAL_INVESTIGATOR
References: