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Integrating Supportive Care in Cystic Fibrosis

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ClinicalTrials.gov Identifier: NCT02668575
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Cystic Fibrosis Foundation
Information provided by (Responsible Party):
Dio Kavalieratos, PhD, 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Behavioral: Supportive Care Intervention Not Applicable

Detailed Description:
As described above.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
Actual Study Start Date : March 2, 2016
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : October 7, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
No Intervention: 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.
Experimental: Supportive Care Intervention
Patients randomized to the intervention arm will receive a protocolized supportive care intervention from a palliative care nurse practitioner.
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.




Primary Outcome Measures :
  1. Feasibility of intervention [ Time Frame: 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.

  2. Acceptability of intervention [ Time Frame: Up to 9 months (+/- 4 weeks) ]
    Measured by: proportion of participants who endorse the intervention as acceptable.

  3. Perceived effectiveness of intervention [ Time Frame: Up to 9 months (+/- 4 weeks) ]
    Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.

  4. Intervention fidelity [ Time Frame: 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.


Secondary Outcome Measures :
  1. Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R) [ Time Frame: 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.

  2. Patient mood [ Time Frame: 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.

  3. Coping style [ Time Frame: 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.

  4. Satisfaction with care [ Time Frame: 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.

  5. Symptom burden [ Time Frame: 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.


Other Outcome Measures:
  1. Healthcare utilization [ Time Frame: Up to 12 months ]
    The investigators will evaluate various measures of healthcare utilization, such as: ED visits, unplanned hospitalizations, and healthcare expenditures.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668575


Locations
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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Cystic Fibrosis Foundation
Investigators
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Principal Investigator: 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

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Responsible Party: Dio Kavalieratos, PhD, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02668575     History of Changes
Other Study ID Numbers: IRB#: PRO14110168
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: It is possible that the investigators may use the information obtained from this study in other research studies examining the treatment of Cystic Fibrosis. This information may also be shared with other researchers here and at other research centers, but those researchers will never be provided with any personal identifiers that would allow them to learn participant's identity.
Keywords provided by Dio Kavalieratos, PhD, University of Pittsburgh:
Pulmonary Cystic Fibrosis
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases