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

NCT02345798 | Completed DMC

• 2 other identifiers: 14302NCI-2014-02539
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Lung Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Arm I (standard care)

ACTIVE COMPARATOR

Patients and caregivers receive standard care during routine clinic visits.

Procedure: Standard Follow-Up Care; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (video-assisted intervention)

EXPERIMENTAL

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; Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Standard Follow-Up Care PROCEDURE

Undergo usual care

Arm I (standard care)

Caregiver-Related Intervention or Procedure OTHER

Undergo video-assisted intervention

Arm II (video-assisted intervention)

Educational Intervention OTHER

Undergo video-assisted intervention

Also known as: Education for Intervention, Intervention, Educational

Arm II (video-assisted intervention)

Quality-of-Life Assessment OTHER

Undergo quality of life assessment

Also known as: Quality of Life Assessment

Arm I (standard care); Arm II (video-assisted intervention)

Questionnaire Administration OTHER

Undergo questionnaire administration

Arm I (standard care); Arm II (video-assisted intervention)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Jae Kim

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: January 26, 2015
• Study Start: February 11, 2015
• Primary Completion: May 25, 2017
• Study Completion: May 25, 2017
• Last Updated: June 2, 2017

Record last verified: 2017-05

Locations

US (1)