NCT06032273 · University of Washington
Lung Transplant READY CF 2: CARING CF Ancillary RCT
What this study is about
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration.
View original scientific description
Lung transplant is an option for treating end-stage lung disease in cystic fibrosis (CF). In the United States, more people with CF and low lung function die each year than undergo lung transplant. More than half of people with CF who die without a lung transplant were never referred for consideration. Patient preference not to undergo lung transplant may account for 25-40% of decisions to defer referral. Patients' health discussion networks function to support individuals in health related matters and may provide critical support during the lung transplant journey. Increasing awareness of lung transplant, and promoting the process of deliberation and utilization of social support, could reduce the number of people with CF who die without lung transplant. Additionally, the most common patient-endorsed barrier to lung transplant discussions is a worry about being a burden on family and friends after lung transplant. For lung transplant recipients with complex post-operative courses, low social support is associated with increased mortality. Additionally, adequate social support is a requirement at all lung transplant programs in the US. Investigators are interested in understanding how caregivers may benefit from using lung transplant educational resources and how caregivers prepare for having discussions with their loved ones and/or helping them make decisions about lung transplant as a treatment option for advanced CF. The purpose of this study is to test whether an investigator-designed research website compared to no caregiver intervention reduces caregiver burden (assessed with the Brief Assessment Scale for Caregivers, BASC), caregiver preparedness for lung transplant discussions, and caregiver lung transplant knowledge as an ancillary study in a multicenter RCT. Further, investigators will assess patient perceptions of caregiver support as measured by the Social Support Effectiveness Questionnaire (SSE-Q) and evaluate caregivers' willingness to provide support through semi-structured interviews in patient-caregiver dyads.
Interventions
BEHAVIORAL
Investigator-designed lung transplant education website
Caregiver participants assigned to the intervention will access the investigator-designed educational resource via their login to a secure website.
Primary outcome measures
Brief Assessment Scale for Caregivers (BASC)
Time frame: Measured at the 3-month and 6-month study visits
The co-primary endpoint is an intention-to-treat assessment of the difference in caregivers' mean change in Brief Assessment Scale for Caregivers (BASC) in the intervention versus control arms of the study from the 3-month to the 6-month study visit using linear mixed models. The BASC is a validated 14-item measure of caregiver burden and includes subscales that reflect positive personal impact (PPI) and negative personal impact (NPI) of caregiving responsibilities. The BASC includes a 4-point Likert scale (scored 0 to 3), with higher scores indicating more burden, and the overall BASC score is an average of the 14 item scores. The BASC has high internal consistency in caregivers for adults with CF (Cronbach's alpha 0.88 for overall BASC and 0.82 for PPI).
Social Support Effectiveness Questionnaire (SSE-Q)
Time frame: Measured at the 3-month and 6-month study visits
A co-primary endpoint is an intention-to-treat assessment of change in patient's Social Support Effectiveness Questionnaire (SSE-Q) from 3 months to 6 months and investigators will compare mean change between patients whose caregivers were randomized to the intervention versus control using linear mixed models. The SSE-Q is a validated 26-item measure of social support with higher scores indicating more effective support. The overall scale ranges from 0 to 80 and each subscale can range from 0 to 20. There are 4 subscales: task support, informational support, emotional support and negative effects of support. The first 15 questions are rated on a 5-point Likert scale and the last questions have yes/no responses. The SSE-Q has not previously been utilized in the CF population.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Identified as a caregiver or loved one of an individual with CF enrolled in the Lung Transplant READY CF 2 parent RCT, or
- An individual with CF enrolled in the Lung Transplant READY CF 2 parent RCT
Exclusion criteria
- People who are unable to provide informed consent
- Unable to read or understand English or Spanish to complete surveys or access the website (currently only available in English and Spanish)
Where
- Seattle, Washington
Collaborators
Cystic Fibrosis Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 6, 2024 · Source of record for eligibility and locations