Clinical trial NCT05215769: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-01-31
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Message-specific knowledge/recall accuracy
timeFrame: Immediately before and immediately after video intervention
Secondary outcomes:
measure: Change in patient genomic knowledge
timeFrame: Immediately before and immediately after video intervention
measure: Change in patient trust of physician/provider
timeFrame: Immediately before and immediately after video intervention
measure: Change in patient genomic knowledge in metastatic breast cancer (MBC) versus metastatic lung cancer (MLC) patients
timeFrame: Immediately before and immediately after video intervention
measure: Change in patient trust of physician/provider in MBC versus MLC patients
timeFrame: Immediately before and immediately after video intervention
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Lima
country: United States
facility: St. Rita's
state: Ohio
city: Richmond
country: United States
facility: Saint Francis Medical Center
state: Ohio
city: Youngstown
country: United States
facility: Saint Elizabeth Youngstown Hospital
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Daniel G Stover, MD
role: PRINCIPAL_INVESTIGATOR
References: