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

Study 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.

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

Conditions
-----------------
Malignant Lung Neoplasm

Intervention / Treatment
-----------------
* Procedure: Standard Follow-Up Care
* Other: Caregiver-Related Intervention or Procedure
* Other: Educational Intervention
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (standard care)<br>Patients and caregivers receive standard care during routine clinic visits. | Procedure: Standard Follow-Up Care<br>* Undergo usual care<br>Other: Quality-of-Life Assessment<br>* Undergo quality of life assessment<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Undergo questionnaire administration<br>|
| Experimental: Arm II (video-assisted intervention)<br>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. | Other: Caregiver-Related Intervention or Procedure<br>* Undergo video-assisted intervention<br>Other: Educational Intervention<br>* Undergo video-assisted intervention<br>* Other names: Intervention, Educational;Other: Quality-of-Life Assessment<br>* Undergo quality of life assessment<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Undergo questionnaire administration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH) | 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. | Up to 2 months | 
| Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH | 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. | Up to 2 months |