Clinical trial NCT02345798: Video-Assisted Intervention in Improving Recovery in Patients With Cancer Undergoing Lung Surgery and Caregivers
Official title: Preparing Patients and Informal Caregivers for Lung Surgery: Pilot Study of a Video-Assisted Intervention to Enhance Post-Operative Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Lung Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-26
Enrollment: 73
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH)
timeFrame: Up to 2 months
measure: Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Jae Kim
role: PRINCIPAL_INVESTIGATOR
References: