Pilot Randomized Trial of an Educational Intervention About Immunotherapy for Patients With Advanced Cancer and Their Caregivers
Harvard Medical School, Boston, MA
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Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Uniondale, NY
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Harvard Medical School, Boston, MA
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Columbia University Vagelos College of Physicians and Surgeons, New York, NY
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Harvard Medical School, Boston, MA
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Harvard Medical School, Boston, MA
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Harvard Medical School, Boston, MA
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ACP Decisions, Newton, MA
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Harvard Medical School, Boston, MA
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Harvard Medical School, Boston, MA
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Background: Immune checkpoint inhibitors (ICIs) are widely used cancer drugs. We developed “UPLIFT,” a video and question prompt list (QPL) intervention to educate patients about ICI risks and benefits. Patients and Methods: We conducted a randomized controlled trial of UPLIFT versus usual care among 130 adults initiating ICIs and caregivers. Dyads were randomized 1:1 to receive UPLIFT or usual care prior to ICI initiation. Participants completed surveys at enrollment, 72 hours, and 6 weeks post-ICI initiation. The primary outcomes were feasibility (≥70% enrollment of eligible patients and ≥80% of UPLIFT patients reviewing the video and QPL) and ICI knowledge (8 items, scored as % correct). We also assessed acceptability of UPLIFT (3 items), anxiety (6-item State-Trait Anxiety Inventory), and patient activation (number of questions asked in oncology visit). We used descriptive statistics, analysis of covariance (ANCOVA), and negative binomial models. Results: We enrolled 130 of 178 eligible patients (73%) and 56 caregivers. Patients (mean age, 67 years [range, 31–92]) had diagnoses of melanoma (41%), lung cancer (26%), or other cancers. All UPLIFT patients (100%) watched the video; 47% used the QPL. Nearly all patients (61/65; 94%) felt “somewhat” or “very comfortable” with UPLIFT. ICI knowledge improved among UPLIFT patients versus controls at 72 hours (difference in adjusted mean % correct at 72 hours, 9% [95% CI, 3%–16%]). The change in anxiety at 72 hours did not significantly differ and there was no difference in knowledge or anxiety change at 6 weeks across groups. UPLIFT patients asked more questions (ratio, 1.27 [95% CI, 0.97–1.66]). Conclusions: A novel educational intervention about ICI risks and benefits was feasible to deliver, deemed acceptable, and shows promise in improving knowledge and activation to ask questions without increasing anxiety. A future study evaluating UPLIFT’s efficacy in these and other outcomes, including severe ICI toxicity, is warranted.
Submitted May 10, 2024; final revision received October 9, 2024; accepted for publication October 11, 2024.
Author contributions: Study conception & design: Petrillo, Hsu, Sullivan, Reynolds, El-Jawahri, Volandes, Greer, Temel. Material preparation: Petrillo, Hsu, Zhou, Sarathy, Tran, El-Jawahri, Volandes, Greer, Temel. Data collection: Petrillo, Hsu, Zhou, Sarathy, Tran, El-Jawahri, Volandes, Greer, Temel. Data analysis: Petrillo, Hsu, Pintro, Rabideau, Zhou, Sarathy, Tran, El-Jawahri, Volandes, Greer, Temel. Writing—original draft: Petrillo. Writing—review & editing: All authors.
Disclosures: Dr. Sullivan has disclosed serving as a consultant for Novartis, Bristol Myers Squibb, and Pfizer; receiving grant/research support from Merck, Bristol Myers Squibb, and Regeneron; receiving institutional grant/research support from Merck; and serving as a scientific advisor for Merck and Bristol Myers Squibb. Dr. Greer has disclosed serving as a scientific advisor for BeiGene; and receiving grant/research support from Blue Note Therapeutics. The remaining authors have disclosed that they have no financial interests, arrangements, affiliations, or commercial interests with the manufacturers of any products discussed in this article or their competitors.
Funding: This work was supported by funding from the Conquer Cancer Foundation (Career Development Award; L.A. Petrillo), National Cancer Institute of the National Institutes of Health under award number K08CA263549 (L.A. Petrillo), American Cancer Society (Clinical Research Professor; J.S. Temel), and Leukemia and Lymphoma Society (Scholar in Clinical Research; A. El-Jawahri).
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7079. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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