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

Primary Purpose

Malignant Lung Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Follow-Up Care
Caregiver-Related Intervention or Procedure
Educational Intervention
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
City of Hope Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Lung Neoplasm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • City of Hope Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard care)

Arm II (video-assisted intervention)

Arm Description

Patients and caregivers receive standard care during routine clinic visits.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 22, 2014
Last Updated
May 31, 2017
Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02345798
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 11, 2015 (Actual)
Primary Completion Date
May 25, 2017 (Actual)
Study Completion Date
May 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
City of Hope Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Lung Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard care)
Arm Type
Active Comparator
Arm Description
Patients and caregivers receive standard care during routine clinic visits.
Arm Title
Arm II (video-assisted intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard Follow-Up Care
Intervention Description
Undergo usual care
Intervention Type
Other
Intervention Name(s)
Caregiver-Related Intervention or Procedure
Intervention Description
Undergo video-assisted intervention
Intervention Type
Other
Intervention Name(s)
Educational Intervention
Other Intervention Name(s)
Education for Intervention, Intervention, Educational
Intervention Description
Undergo video-assisted intervention
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Undergo quality of life assessment
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Undergo questionnaire administration
Primary Outcome Measure Information:
Title
Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH)
Description
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.
Time Frame
Up to 2 months
Title
Informal caregiver-reported outcomes to video-assisted intervention among the lung surgery population at COH
Description
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.
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Kim
Organizational Affiliation
City of Hope Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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