Integrating Supportive Care in Cystic Fibrosis

University of Pittsburgh

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Supportive Care Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02668575

IRB#: PRO14110168

Details and patient eligibility

About

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.

Full description

As described above.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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 group

Description:

Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.

Treatment:

Behavioral: Supportive Care Intervention