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

NCT ID: NCT02345798

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-11
• Study Completion Date: 2017-05-25

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.

Conditions

Malignant Lung Neoplasm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (standard care)

Patients and caregivers receive standard care during routine clinic visits.

Group Type: ACTIVE_COMPARATOR

Standard Follow-Up Care

Intervention Type: PROCEDURE

Undergo usual care

Quality-of-Life Assessment

Intervention Type: OTHER

Undergo quality of life assessment

Questionnaire Administration

Intervention Type: OTHER

Undergo questionnaire administration

Arm II (video-assisted 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.

Group Type: EXPERIMENTAL

Caregiver-Related Intervention or Procedure

Intervention Type: OTHER

Undergo video-assisted intervention

Educational Intervention

Intervention Type: OTHER

Undergo video-assisted intervention

Quality-of-Life Assessment

Intervention Type: OTHER

Undergo quality of life assessment

Questionnaire Administration

Intervention Type: OTHER

Undergo questionnaire administration

Interventions

Standard Follow-Up Care

Undergo usual care

Intervention Type: PROCEDURE

Caregiver-Related Intervention or Procedure

Undergo video-assisted intervention

Intervention Type: OTHER

Educational Intervention

Undergo video-assisted intervention

Intervention Type: OTHER

Quality-of-Life Assessment

Undergo quality of life assessment

Intervention Type: OTHER

Questionnaire Administration

Undergo questionnaire administration

Intervention Type: OTHER

Other Intervention Names

Education for Intervention; Intervention, Educational; Quality of Life Assessment

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jae Kim

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2014-02539

Identifier Type: REGISTRY

Identifier Source: secondary_id

14302

Identifier Type: OTHER

Identifier Source: secondary_id

14302

Identifier Type: -

Identifier Source: org_study_id