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Completed

NCT Number: NCT02668575

Integrating Supportive Care in Cystic Fibrosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

About this study

As described above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

Integrating Supportive Care in Cystic Fibrosis: A Pilot Study

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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