Integrating Supportive Care in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Integrating Supportive Care in Cystic Fibrosis: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668575
• Other study ID #: IRB#: PRO14110168
• Status: Completed
• Phase: N/A
• Start date: March 2, 2016
• Est. completion date: October 7, 2019

Study information

• Verified date: February 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

As described above.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 7, 2019
• Est. primary completion date: November 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Healthcare utilization	The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.	Up to 12 months
Primary	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)
Primary	Acceptability of intervention	Measured by: proportion of participants who endorse the intervention as acceptable.	Up to 9 months (+/- 4 weeks)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)