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

Malignant Lung Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345798
• Other study ID #: 14302
• Secondary ID: NCI-2014-0253914
• Status: Completed
• Phase: N/A
• First received: December 22, 2014
• Last updated: May 31, 2017
• Start date: February 11, 2015
• Est. completion date: May 25, 2017

Study information

• Verified date: May 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Lung Neoplasm

Intervention

Procedure:
• Standard Follow-Up Care
Undergo usual care

Other:
• Caregiver-Related Intervention or Procedure
Undergo video-assisted intervention
• Educational Intervention
Undergo video-assisted intervention
• Quality-of-Life Assessment
Undergo quality of life assessment
• Questionnaire Administration
Undergo questionnaire administration

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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