Lung Transplant READY CF 2: CARING CF Ancillary RCT

NCT06032273 | Recruiting

• 1 other identifier: STUDY00016943
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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. Study involvement will span 6 months and study activities will involve the following:

• Three Zoom research sessions (15-90 minutes each)
• Survey assessments and an interview
• Access to a research website that contains educational resources about lung transplant

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Lung Transplantation; Advanced Lung Disease; Caregiver

Outcome Measures

Primary Outcomes (2)

• Brief Assessment Scale for Caregivers (BASC)

  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).

  Measured at the 3-month and 6-month study visits

• Social Support Effectiveness Questionnaire (SSE-Q)

  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.

  Measured at the 3-month and 6-month study visits

Secondary Outcomes (4)

• Confidence-weighted true false knowledge about lung transplant (14-question investigator-designed survey)

  Measured at the 3-month and 6-month study visits

• Likert-scale rating of preparedness to discuss lung transplant with their loved one (0-4)

  Measured at the 3-month and 6-month study visits

• Patient Health Questionnaire (PHQ-8)

  Measured at the 3-month and 6-month study visits

• Generalized Anxiety Disorder 7-item (GAD-7) Scale

  Measured at the 3-month and 6-month study visits

Other Outcomes (5)

• Brief Assessment Scale for Caregivers (BASC): by patient's initial randomization status (intervention or attention control in parent RCT).

  Measured at the baseline, 3-month, and 6-month study visits

• Social Support Effectiveness Questionnaire (SSE-Q): by patient's initial randomization status (intervention or attention control in parent RCT).

  Measured at the baseline, 3-month, and 6-month study visits

• Assessment of Brief Assessment Scale for Caregivers (BASC): among caregivers of members of communities of concern (low socioeconomic status, Hispanic ethnicity, or Black/Asian/Other race).

  Measured at the 3-month and 6-month study visits

Study Arms (2)

Access to investigator-designed lung transplant education website

EXPERIMENTAL

Access to an investigator-designed web-based educational resource with information about lung transplant for three months.

Behavioral: Investigator-designed lung transplant education website

No access to lung transplant education website

NO INTERVENTION

No access to the investigator-designed lung transplant educational resource.

Interventions

Investigator-designed lung transplant education website BEHAVIORAL

Caregiver participants assigned to the intervention will access the investigator-designed educational resource via their login to a secure website.

Access to investigator-designed lung transplant education website

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of Washington Medical Center - Montlake

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (2)

• Ramos KJ, Smith PJ, McKone EF, Pilewski JM, Lucy A, Hempstead SE, Tallarico E, Faro A, Rosenbluth DB, Gray AL, Dunitz JM; CF Lung Transplant Referral Guidelines Committee. Lung transplant referral for individuals with cystic fibrosis: Cystic Fibrosis Foundation consensus guidelines. J Cyst Fibros. 2019 May;18(3):321-333. doi: 10.1016/j.jcf.2019.03.002. Epub 2019 Mar 27.

  PMID: 30926322 BACKGROUND

• Hartzler AL, Bartlett LE, Hobler MR, Reid N, Pryor JB, Kapnadak SG, Berry DL, Lober WB, Goss CH, Ramos KJ; Take on Transplant Study Group. Take on transplant: human-centered design of a patient education tool to facilitate informed discussions about lung transplant among people with cystic fibrosis. J Am Med Inform Assoc. 2022 Dec 13;30(1):26-37. doi: 10.1093/jamia/ocac176.

  PMID: 36173364 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Kathleen Ramos, MD, MS

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Bartlett, BS, CCRC

CONTACT

503-583-2869; lrejman@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 11, 2023
• Study Start: September 6, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available after publication of the results of the primary analyses of the study. The data will be available for up to 3 years after the end of the study.
• Access Criteria: Qualified researchers with appropriate clinical research training and/or mentorship will be allowed to have access to IPD after approval is obtained from Human Subjects Division(s) and the study PI.

Locations

US (1)