Study Summary
This trial will help to improve best practices in generalist-level palliative care in CF by providing a framework for a nationally generalizable model.
Eligible Conditions
- Cystic Fibrosis
- Quality of Life
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 13 Secondary · Reporting Duration: 2 years
2 years
Brief Assessment Scale for Caregivers (BASC)
Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Generalized Anxiety Disorder-7 item Scale (GAD-7)
Integrated Palliative Care Outcome Scale (IPOS)
Memorial Symptom Assessment Scale-Cystic Fibrosis (MSAS-CF)
PROMIS® Global Health-Short Form (PGHSF)
PROMIS® Parent Proxy Anxiety-Short Form (PASF)
PROMIS® Parent Proxy Depression-Short Form (PDSF)
PROMIS® Parent Proxy Pain Interference-Short Form 8a (PPISF)
Patient Health Questionnaire-8 (PHQ-8)
Perceived Stress Scale (PSS)
Proportion of individuals with CF receiving annual palliative care screening
Proportion of individuals with CF receiving triggered palliative care screening
Use of primary palliative care provider education materials
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
0 Treatment Group
1001 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
MJHS Institute for Innovation in Palliative CareOTHER
5 Previous Clinical Trials
1,060 Total Patients Enrolled
Emory UniversityOTHER
1,559 Previous Clinical Trials
2,764,770 Total Patients Enrolled
19 Trials studying Cystic Fibrosis
1,263 Patients Enrolled for Cystic Fibrosis
Feinstein Institute for Medical ResearchOTHER
21 Previous Clinical Trials
5,024 Total Patients Enrolled
Stony Brook UniversityOTHER
202 Previous Clinical Trials
35,145 Total Patients Enrolled
2 Trials studying Cystic Fibrosis
115 Patients Enrolled for Cystic Fibrosis
Massachusetts General HospitalLead Sponsor
2,782 Previous Clinical Trials
31,224,303 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
232 Patients Enrolled for Cystic Fibrosis
Icahn School of Medicine at Mount SinaiOTHER
800 Previous Clinical Trials
508,539 Total Patients Enrolled
Anna M Georgiopoulos, MDPrincipal InvestigatorMassachusetts General Hospital (MGH)
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
12 Patients Enrolled for Cystic Fibrosis
Lara Dhingra, PhDPrincipal InvestigatorMJHS Institute for Innovation in Palliative Care (MJHS Institute)
Eligibility Criteria
Age Any Age · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are currently taking CFTR modulators or other medical, psychological, or complementary therapies.
References
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Frequently Asked Questions
Is there still availability for individuals to join this clinical investigation?
"The information on clinicaltrials.gov reveals that this trial is currently recruiting participants, having first been posted on June 25th 2021 and was most recently updated in mid-November of the same year." - Anonymous Online Contributor
Unverified Answer
What is the total number of participants involved in this research project?
"Affirmative. Clinicaltrials.gov has the latest information on this trial, which was first announced on June 25th 2021 and most recently updated November 15th of the same year. This study is seeking 1001 participants from 5 different clinical sites." - Anonymous Online Contributor
Unverified Answer