Video-Assisted Intervention in Improving Recovery in Patients With Cancer Undergoing Lung Surgery and Caregivers

Not Applicable

Completed

• Conditions: Malignant Lung Neoplasm
• Interventions: Procedure: Standard Follow-Up Care; Other: Caregiver-Related Intervention or Procedure; Other: Quality-of-Life Assessment; Other: Educational Intervention; Other: Questionnaire Administration

• Registration Number: NCT02345798
• Lead Sponsor: City of Hope Medical Center

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.

Study Timeline

• Study First Submitted: 2014-12-22
• Study First Submitted QC: 2015-01-19
• Study First Posted: 2015-01-26
• Study Start: 2015-02-11
• Status Verified: 2017-05
• Primary Completion: 2017-05-25
• Study Completion: 2017-05-25
• Last Update Submitted: 2017-05-31
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (standard care)	Quality-of-Life Assessment	Patients and caregivers receive standard care during routine clinic visits.
Arm II (video-assisted intervention)	Educational Intervention	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.
Arm I (standard care)	Standard Follow-Up Care	Patients and caregivers receive standard care during routine clinic visits.
Arm I (standard care)	Questionnaire Administration	Patients and caregivers receive standard care during routine clinic visits.
Arm II (video-assisted intervention)	Caregiver-Related Intervention or Procedure	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.
Arm II (video-assisted intervention)	Quality-of-Life Assessment	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.
Arm II (video-assisted intervention)	Questionnaire Administration	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.

Primary Outcome Measures

Name	Time	Method
Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH	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)	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.

Trial Locations

Locations (1)

City of Hope Medical Center; 🇺🇸 Duarte, California, United States