Integrating Supportive Care in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Supportive Care Intervention

• Registration Number: NCT02668575
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study First Submitted: 2016-01-14
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Study Start: 2016-03-02
• Primary Completion: 2018-11-29
• Study Completion: 2019-10-07
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Care Intervention	Supportive Care Intervention	Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.

Primary Outcome Measures

Name	Time	Method
Intervention fidelity	Up to 9 months (+/- 4 weeks)	Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
Feasibility of intervention	Up to 9 months (+/- 4 weeks)	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.
Acceptability of intervention	Up to 9 months (+/- 4 weeks)	Measured by: proportion of participants who endorse the intervention as acceptable.
Perceived effectiveness of intervention	Up to 9 months (+/- 4 weeks)	Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.

Secondary Outcome Measures

Name	Time	Method
Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)	Up to 9 months (+/- 4 weeks)	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.
Coping style	Up to 9 months (+/- 4 weeks)	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.
Symptom burden	Up to 9 months (+/- 4 weeks)	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.
Patient mood	Up to 9 months (+/- 4 weeks)	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.
Satisfaction with care	Up to 9 months (+/- 4 weeks)	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.

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States