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Clinical Trials/NCT02345798
NCT02345798
Completed
N/A

Preparing Patients and Informal Caregivers for Lung Surgery: Pilot Study of a Video-Assisted Intervention to Enhance Post-Operative Recovery

City of Hope Medical Center1 site in 1 country73 target enrollmentFebruary 11, 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Malignant Lung Neoplasm
Sponsor
City of Hope Medical Center
Enrollment
73
Locations
1
Primary Endpoint
Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

This pilot clinical trial studies a video-assisted intervention in improving recovery of patients undergoing surgery to remove lung cancer or cancer that has spread to the lung and their caregivers. The intervention uses educational videos to prepare patients and families for surgery and teach them how to manage the symptoms after surgery. Teaching patients and their families what to expect before and after surgery may help improve patient and caregiver quality of life, help patients recover better from surgery, and support families in their role as caregivers after surgery.

Detailed Description

PRIMARY OBJECTIVES: I. To pilot test a video-assisted intervention designed to enhance post-operative recovery by preparing patients and informal caregivers for lung surgery. SECONDARY OBJECTIVES: I. To describe preliminary effect of the video-assisted intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes. OUTLINE: Patients and their caregivers are assigned to 1 of 2 arms. ARM I: Patients and caregivers receive standard care during routine clinic visits. ARM II: Patients view Parts 1 and 2 of the video program, which focus on what to expect before surgery and after surgery in the hospital, on a tablet over approximately 8 minutes at a scheduled pre-operative visit. Patients then receive an educational handbook and discuss the video with a nurse. After surgery and before hospital discharge, patients view Part 3 of the video over approximately 6 minutes, which focuses on what to expect after going home. After completion of study, patients and caregivers are followed up at approximately 2-4 weeks and 2 months.

Registry
clinicaltrials.gov
Start Date
February 11, 2015
End Date
May 25, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
City of Hope Medical Center
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PATIENTS: Scheduled to undergo surgery with lung resection for treatment of primary or secondary neoplasms of the lung
  • PATIENTS: Able to read and understand English
  • INFORMAL CAREGIVERS: The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery
  • INFORMAL CAREGIVERS: Able to read and understand English
  • This protocol is eligible for waiver of informed consent documentation; all subjects must have the ability to understand and the willingness to provide verbal informed consent

Exclusion Criteria

  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Outcomes

Primary Outcomes

Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH

Time Frame: Up to 2 months

Informal caregiver-reported outcomes assessed using the STAI. For all informal caregiver-reported outcomes, data will be summarized using descriptive statistics of mean and standard deviation.

Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH)

Time Frame: Up to 2 months

Patient-reported outcomes assessed using the State Trait Anxiety Inventory (STAI), For all patient-reported outcomes, data will be summarized using descriptive statistics of mean and standard deviation.

Study Sites (1)

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