Clinical Trial: Integrating Supportive Care in Cystic Fibrosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Integrating Supportive Care in Cystic Fibrosis: A Pilot Study

Brief Summary: 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.

Detailed Summary: As described above.
Sponsor: University of Pittsburgh

Current Primary Outcome:

• 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.
• Acceptability of intervention [ Time Frame: Up to 9 months (+/- 4 weeks) ]
  Measured by: proportion of participants who endorse the intervention as acceptable.
• 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.
• 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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Quality of life [ 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: January 14, 2016
Date Started: February 2016
Date Completion: June 2018
Last Updated: May 2, 2016
Last Verified: May 2016