Malignant Lung NeoplasmNCT02345798
Video-Assisted Intervention in Improving Recovery in Patients With Cancer Undergoing Lung Surgery and Caregivers
A study testing Standard Follow-Up Care, Caregiver-Related Intervention or Procedure and Educational Intervention in people with Malignant Lung Neoplasm, run by City of Hope Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Lung Neoplasm
- What is being tested?
- Standard Follow-Up Care, Caregiver-Related Intervention or Procedure and Educational Intervention
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2015to 25 May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Preparing Patients and Informal Caregivers for Lung Surgery: Pilot Study of a Video-Assisted Intervention to Enhance Post-Operative Recovery
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To pilot test a video-assisted intervention designed to enhance post-operative recovery by preparing patients and informal caregivers for lung surgery.
SECONDARY OBJECTIVES:
- 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
- Being tested
- Standard Follow-Up Care, Caregiver-Related Intervention or Procedure, Educational Intervention, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Follow-Up CareProcedure or surgery
Undergo usual care
Caregiver-Related Intervention or ProcedureOther
Undergo video-assisted intervention
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Undergo video-assisted intervention
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Undergo quality of life assessment
Questionnaire AdministrationOther
Undergo questionnaire administration
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard care) | Active comparator | Patients and caregivers receive standard care during routine clinic visits. Receives: 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. Receives: Other: Caregiver-Related Intervention or Procedure; Other: Educational Intervention; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start11 Feb 2015
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jae Kim, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345798
- Sponsor's protocol ID
- 14302
- Other IDs
- NCI-2014-02539, 14302
- Status last verified
- May 2017
- First submitted
- 22 Dec 2014
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing Patients and Informal Caregivers for Lung Surgery: Pilot Study of a Video-Assisted Intervention to Enhance Post-Operative Recovery
- ClinicalTrials.gov ID
- NCT02345798
- Acronym / sponsor ID
- 14302
- Conditions
- Malignant Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Feb 2015 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To pilot test a video-assisted intervention designed to enhance post-operative recovery by preparing patients and informal caregivers for lung surgery.
SECONDARY OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard care) | Active comparator | Procedure: Standard Follow-Up Care, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients and caregivers receive standard care during routine clinic visits. |
| Arm II (video-assisted intervention) | Experimental | Other: Caregiver-Related Intervention or Procedure, Other: Educational Intervention, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Follow-Up CareUndergo usual care | Procedure or surgery | Arm I (standard care) |
| Caregiver-Related Intervention or ProcedureUndergo video-assisted intervention | Other | Arm II (video-assisted intervention) |
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalUndergo video-assisted intervention | Other | Arm II (video-assisted intervention) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentUndergo quality of life assessment | Other | Arm I (standard care), Arm II (video-assisted intervention) |
| Questionnaire AdministrationUndergo questionnaire administration | Other | Arm I (standard care), Arm II (video-assisted intervention) |
Primary outcome
Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH)
Time frame: Up to 2 months
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
Time frame: Up to 2 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
Related trials for Malignant Lung Neoplasm
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Enrolling by invitationPhase 1
Evaluation of the I-phase Clinical Trial of 177Lu-HX02 Injection in Patients With Advanced Malignant Solid Tumors
Soft Tissue Sarcoma, Non-small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Kim principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Follow-Up Care, Caregiver-Related Intervention or Procedure and Educational Intervention in people with Malignant Lung Neoplasm, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcomes to video-assisted intervention among the lung surgery population at City of Hope (COH) (time frame: Up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.