Integrating Supportive Care in Cystic Fibrosis

NCT02668575 | Completed

• 1 other identifier: IRB#: PRO14110168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Pulmonary Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  Up to 9 months (+/- 4 weeks)

• Patient mood

  Up to 9 months (+/- 4 weeks)

• Coping style

  Up to 9 months (+/- 4 weeks)

• Satisfaction with care

  Up to 9 months (+/- 4 weeks)

• Symptom burden

  Up to 9 months (+/- 4 weeks)

Other Outcomes (1)

• Healthcare utilization

  Up to 12 months

Study Arms (2)

Usual Care

NO INTERVENTION

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

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

Behavioral: Supportive Care Intervention

Interventions

Supportive Care Intervention 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.

Supportive Care Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Females who are pregnant
• Prior receipt of specialist SC services
• Cognitive impairments
• Patients younger than 18 years of age

Sponsors & Collaborators

• University of Pittsburgh: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: January 14, 2016
• First Posted: January 29, 2016
• Study Start: March 2, 2016
• Primary Completion: November 29, 2018
• Study Completion: October 7, 2019
• Last Updated: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)