Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05215769
  4. Details
NCT05215769 Clinical Trial

A Video Intervention to Improve Patient Understanding of Tumor Genomic Testing in Patients With Metastatic Cancer

Metastatic Malignant Solid Neoplasm Clinical Trial

Official title:
Video Intervention to Address Pre-Test Patient Education for Tumor Genomic Testing

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05215769
Other study ID # OSU-21313
Secondary ID NCI-2021-13900R2
Status Recruiting
Phase N/A
First received
Last updated
Start date March 30, 2022
Est. completion date December 31, 2025

Study information
Verified date December 2023
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 225
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Health Education
Participate in a video intervention
Other:
• Questionnaire Administration
Complete questionnaires

Locations
Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States St. Rita's Lima Ohio
United States Saint Francis Medical Center Richmond Ohio
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio

Sponsors (2)
Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Immediately before and immediately after video intervention
Secondary 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. Immediately before and immediately after video intervention
Secondary 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. Immediately before and immediately after video intervention
Secondary 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. Immediately before and immediately after video intervention
Secondary 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. Immediately before and immediately after video intervention
See also
  Status Clinical Trial Phase
Completed NCT02317874 - Testing the Addition of the Anti-Cancer Drug Talazoparib to the Combination of Carboplatin and Paclitaxel for the Treatment of Advanced Cancer Phase 1
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Not yet recruiting NCT05095948 - Improving Processes of Cancer Care Delivery at a Comprehensive Cancer Center
Recruiting NCT05691491 - Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness Phase 1/Phase 2
Active, not recruiting NCT03218826 - PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Recruiting NCT05554380 - Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With AKT Mutations, A ComboMATCH Treatment Trial Phase 2
Recruiting NCT04957615 - Nivolumab for the Treatment of Metastatic or Unresectable Solid Tumors With ARID1A Mutation and CXCL13 Expression Phase 2
Active, not recruiting NCT04294628 - Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03065387 - Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation Phase 1
Withdrawn NCT04820894 - Perception of Cure Among Patients With Metastatic Cancer
Completed NCT03229278 - Trigriluzole With Nivolumab and Pembrolizumab in Treating Patients With Metastatic or Unresectable Solid Malignancies or Lymphoma Phase 1
Recruiting NCT02408861 - Nivolumab and Ipilimumab in Treating Patients With HIV Associated Relapsed or Refractory Classical Hodgkin Lymphoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Phase 1
Active, not recruiting NCT04514497 - Testing the Addition of an Anti-cancer Drug, BAY 1895344, to Usual Chemotherapy for Advanced Stage Solid Tumors, With a Specific Focus on Patients With Small Cell Lung Cancer, Poorly Differentiated Neuroendocrine Cancer, and Pancreatic Cancer Phase 1
Recruiting NCT04673448 - Niraparib and TSR-042 for the Treatment of BRCA-Mutated Unresectable or Metastatic Breast, Pancreas, Ovary, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Recruiting NCT05638295 - Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial) Phase 2
Recruiting NCT05455606 - Does the Use of a Genomic Tumor Board Increase the Number of Patients Who Receive Genome-Informed Treatment N/A
Recruiting NCT05101356 - A Cancer Vaccine (Labvax 3(22)-23) and GM-CSF Alone or in Combination With Pembrolizumab for the Treatment of Advanced Stage Adenocarcinoma Phase 1/Phase 2
Recruiting NCT04960787 - Financial Navigation Program to Improve Understanding and Management of Financial Aspects of Cancer Care for Patients and Their Spouses N/A
Recruiting NCT05803382 - Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers Phase 1
Active, not recruiting NCT02143401 - Navitoclax and Sorafenib Tosylate in Treating Patients With Relapsed or Refractory Solid Tumors Phase 1

External Links