Integrating Supportive Care in Cystic Fibrosis

NCT ID: NCT02668575

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-02
• Study Completion Date: 2019-10-07

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Supportive Care Intervention

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

Group Type: EXPERIMENTAL

Supportive Care Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Dio Kavalieratos, PhD

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dio Kavalieratos, PhD

Role: PRINCIPAL_INVESTIGATOR

Section of Palliative Care and Medical Ethics; Division of General Internal Medicine, University of Pittsburgh

Joseph Pilewski, MD

Role: PRINCIPAL_INVESTIGATOR

Pulmonary, Allergy, and Critical Care Medicine Division; University of Pittsburgh

Locations

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

IRB#: PRO14110168

Identifier Type: -

Identifier Source: org_study_id