A randomized study of genetic education versus usual care in tumor profiling for advanced cancer in the ECOG-ACRIN Cancer Research Group (EAQ152)

Abstract

Background: Enthusiasm for precision oncology may obscure the psychosocial and ethical considerations associated with the implementation of tumor genetic sequencing.

Methods: Patients with advanced cancer undergoing tumor-only genetic sequencing in the National Cancer Institute Molecular Analysis for Therapy Choice (MATCH) trial were randomized to a web-based genetic education intervention or usual care. The primary outcomes were knowledge, anxiety, depression, and cancer-specific distress collected at baseline (T0), posteducation (T1) and after results (T2). Two-sided, 2-sample t tests and univariate and multivariable generalized linear models were used.

Results: Five hundred ninety-four patients (80% from NCI Community Oncology Research Program sites) were randomized to the web intervention (n = 293) or usual care (n = 301) before the receipt of results. Patients in the intervention arm had greater increases in knowledge (P for T1-T0 < .0001; P for T2-T0 = .003), but there were no significant differences in distress outcomes. In unadjusted moderator analyses, there was a decrease in cancer-specific distress among women (T0-T1) in the intervention arm but not among men. Patients with lower health literacy in the intervention arm had greater increases in cancer-specific distress and less decline in general anxiety (T0-T1) and greater increases in depression (T0-T2) in comparison with those receiving usual care.

Conclusions: Web-based genetic education before tumor-only sequencing results increases patient understanding and reduces distress in women. Refinements to the intervention could benefit low-literacy groups and men.

Trial registration: ClinicalTrials.gov NCT02823652.

Keywords: genetic education; online education intervention; precision oncology; tumor sequencing.

Conflict of interest statement

Angela R. Bradbury reports research support and consulting fees from AstraZeneca and Merck. Angela M. DeMichele reports institutional research support from Pfizer, Genentech, Novartis, and Calithera. Kara N. Maxwell reports payment to her institution from the National Cancer Institute (K08CA215312). Keith T. Flaherty reports grants or contracts from Novartis and Sanofi; consulting fees from Loxo Oncology, Clovis Oncology, Strata Oncology, Vivid Biosciences, Checkmate Pharmaceuticals, Kinnate Pharmaceuticals, Scorpion Therapeutics, X4 Pharmaceuticals, PIC Therapeutics, Sanofi, Amgen, Asana, Adaptimmune, Aeglea, Shattuck Labs, Tolero, Apricity, Oncoceutics, Fog Pharma, Neon, Tvardi, xCures, Monopteros, Vibliome, ALX Oncology, Lilly, Novartis, Genentech, Bristol‐Myers Squibb, Merck, Takeda, Verastem, Boston Biomedical, Pierre Fabre, and Debiopharm; participation on boards for X4 Pharmaceuticals, PIC Therapeutics, Sanofi, Amgen, Asana, Adaptimmune, Aeglea, Shattuck Labs, Tolero, Apricity, Oncoceutics, Fog Pharma, Neon, Tvardi, xCures, Monopteros, Vibliome, ALX Oncology, Lilly, Novartis, Genentech, Bristol‐Myers Squibb, Merck, Takeda, Verastem, Boston Biomedical, Pierre Fabre, and Debiopharm; leadership or fiduciary roles with Loxo Oncology, Clovis Oncology, Strata Oncology, Vivid Biosciences, Checkmate Pharmaceuticals, Kinnate Pharmaceuticals, and Scorpion Therapeutics; and stock or stock options in Loxo Oncology, Clovis Oncology, Strata Oncology, Vivid Biosciences, Checkmate Pharmaceuticals, Kinnate Pharmaceuticals, Scorpion Therapeutics, X4 Pharmaceuticals, PIC Therapeutics, Apricity, Oncoceutics, Fog Pharma, Tvardi, xCures, Monopteros, Vibliome, and ALX Oncology. Stefan C. Grant reports funding support from Guardant Health and a stipend for serving as vicechair of a steering committee for the Precision Medicine Exchange Consortium. Ruth C. Carlos reports travel reimbursement from ECOG‐ACRIN, RSNA, ARRS, and ARBIR; participation on a data safety monitoring board for ECOG‐ACRIN; stock or stock options in ARBIR; and salary support from JACR. Lynne I. Wagner reports consulting fees from Celgene (Bristol‐Myers Squibb) and Athenex. The other authors made no disclosures.

© 2021 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.

Figures

Figure 1

Consolidated Standards of Reporting Trials diagram. Values in parentheses refer to the number of patients from preceding boxes, with each value corresponding to the row in order. Bolded values refer to the number of participants who did not receive the assigned web education intervention. COMET indicates Communication and Education in Tumor Profiling; MATCH, Molecular Analysis for Therapy Choice; T0, baseline; T1, posteducation; T2, after result disclosure.

Figure 2

Mean change scores and 95% confidence intervals by assigned arm and outcome: (A) mean change scores (T1‐T0) and (B) mean change scores (T2‐T0). Positive scores are a favorable outcome for genetic knowledge (eg, increased knowledge), whereas negative scores are favorable for depression, anxiety, and cancer‐specific distress (eg, reduced depression, anxiety, or distress).

Figure 3

Cancer‐specific distress mean change scores (T1‐T0) and 95% confidence intervals by sex and assigned arm.

Figure 4

Affective outcomes by health literacy and arm: (A) cancer‐specific distress mean change scores (T1‐T0) by health literacy and arm, (B) PROMIS anxiety mean change scores (T1‐T0) by health literacy and arm, and (C) PROMIS depression mean change scores (T2‐T0) by health literacy and arm. Regression lines with 95% confidence intervals are shown by assigned arm. PROMIS indicates Patient‐Reported Outcomes Measurement Information System.