Integrating Supportive Care in Cystic Fibrosis
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | March 2, 2016 |
| End Date: | May 1, 2019 |
Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
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.
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.
As described above.
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
We found this trial at
1
site
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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