A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
Primary Purpose
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Education
Questionnaire Administration
Sponsored by
About this trial
This is an interventional health services research trial for Anatomic Stage IV Breast Cancer AJCC v8
Eligibility Criteria
Inclusion Criteria:
- Patients must have biopsy-confirmed metastatic cancer
- Be >= 18 years of age
- Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS
Exclusion Criteria:
- Exclude patients who are not English- or Spanish-speaking
Sites / Locations
- Ohio State University Comprehensive Cancer CenterRecruiting
- St. Rita's
- Saint Francis Medical CenterRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Health services research (video)
Arm Description
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Outcomes
Primary Outcome Measures
Message-specific knowledge/recall accuracy
Measured as number correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05.
Secondary Outcome Measures
Change in patient genomic knowledge
Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.
Change in patient trust of physician/provider
Measured with the 11-item trust in physician survey (TPS) as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.
Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients
Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.
Change in patient trust of physician/provider in MBC versus MLC patients
Measured with the 11-item TPS as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.
Full Information
NCT ID
NCT05215769
First Posted
January 18, 2022
Last Updated
September 26, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05215769
Brief Title
A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
Official Title
Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial tests whether a video intervention improves patient understanding of tumor genomic testing in patients with cancer that has spread to other parts of the body (metastatic). Measuring how the video intervention affects patient understanding of tumor genomic testing in patients with metastatic cancer may help doctors provide patient-centered care by effectively communicating the importance of tumor genomic testing.
Detailed Description
PRIMARY OBJECTIVE:
I. To assess change in patient knowledge about tumor next generation sequencing (NGS) following exposure to the video.
SECONDARY OBJECTIVES:
I.To assess changes following exposure to the video, including; Ia. Genomic knowledge via the validated 10 true/false question survey (% correct out of 10).
Ib. 11-item Trust in Physician Survey (TPS) as a single TPS score. Ic. Comparison of results in three patient cohorts: 1) Metastatic breast cancer; 2) lung cancer; 3) metastatic cancer of unspecified type.
EXPLORATORY OBJECTIVE:
I. Assess whether therapies prescribed as a result of tumor NGS achieved clinically favorable result through chart review.
OUTLINE:
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic Lung Carcinoma, Metastatic Malignant Solid Neoplasm, Prognostic Stage IV Breast Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Health services research (video)
Arm Type
Experimental
Arm Description
Patients participate in a video intervention session and complete questionnaires at baseline, after participating in the video intervention, and after receiving NGS results.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Participate in a video intervention
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Complete questionnaires
Primary Outcome Measure Information:
Title
Message-specific knowledge/recall accuracy
Description
Measured as number correct out of 10 questions. Will have 90% power to detect an effect size of 0.47 in change of recall accuracy from pre- to post- video intervention, using a two-sided Wilcoxon signed-rank test with alpha of 0.05.
Time Frame
Immediately before and immediately after video intervention
Secondary Outcome Measure Information:
Title
Change in patient genomic knowledge
Description
Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.
Time Frame
Immediately before and immediately after video intervention
Title
Change in patient trust of physician/provider
Description
Measured with the 11-item trust in physician survey (TPS) as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test.
Time Frame
Immediately before and immediately after video intervention
Title
Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients
Description
Measured with the validated 10 true/false question survey (% correct out of 10). Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.
Time Frame
Immediately before and immediately after video intervention
Title
Change in patient trust of physician/provider in MBC versus MLC patients
Description
Measured with the 11-item TPS as a single TPS score. Will be summarized using descriptive statistics and compared pre-/post-video using Wilcoxon signed rank test. Will be compared between MBC and MLC patients using Wilcoxon rank sum test.
Time Frame
Immediately before and immediately after video intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have biopsy-confirmed metastatic cancer
Be >= 18 years of age
Be undergoing clinical tumor or circulating tumor deoxyribonucleic acid (DNA) NGS
Exclusion Criteria:
Exclude patients who are not English- or Spanish-speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
The Ohio State University Comprehensive Cancer Center
Phone
800-293-5066
Email
OSUCCCClinicaltrials@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel G Stover, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel G. Stover, MD
Email
daniel.stover@osumc.edu
First Name & Middle Initial & Last Name & Degree
Daniel G. Stover, MD
Facility Name
St. Rita's
City
Lima
State/Province
Ohio
ZIP/Postal Code
45801
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clarissa Alford, BSN, RN, ONC
Phone
419-226-9617
Email
clalford@mercy.com
First Name & Middle Initial & Last Name & Degree
Michael J. Bishop, MS, MD
Facility Name
Saint Francis Medical Center
City
Richmond
State/Province
Ohio
ZIP/Postal Code
23222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Caramella, RN, BSN
Phone
804-893-8978
Email
Anne.Caramella@bshsi.org
First Name & Middle Initial & Last Name & Degree
William Irvin, MD
Facility Name
Saint Elizabeth Youngstown Hospital
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy Engartner, AAS, BSAS, RN
Phone
330-480-2875
Email
cathy.engartner@mercy.com
First Name & Middle Initial & Last Name & Degree
James Kim, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline
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A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer
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