According to investigators, digitized cognitive behavioral stress management may help clinicians offer more comprehensive cancer care.
Attune, a digital software application (app) designed to help patients manage depression and anxiety, significantly improved the conditions of patients with cancer, according to data from a decentralized randomized controlled trial presented at the 2023 American Society of Clinical Oncology Annual Meeting.
“What we were most excited about with these findings is that [they] show the potential of something like digitized CBSM [cognitive behavioral stress management] to expand access to care and to help clinicians meet comprehensive cancer guidelines,” study co-author Allison Ramiller said during her Saturday afternoon presentation.
The RESTORE study from biotech company Blue Note Therapeutics, the results of which were presented by Ramiller, was a 12-week, double-blind, randomized, controlled trial conducted virtually in 2022, comparing the impact of Attune, a CBSM app designed to be used alongside usual medical and psychosocial oncology care regimens with that of Cerena, a health education control app described by the authors of the study as a “functionally similar sham app.”
Patients using both Attune and Cerena each completed 10 informational sessions that were approximately an hour long, and both apps included guided exercises and other interactive opportunities, according to ClinicalTrials.gov.
The trial included 449 patients with non-metastatic stage I, II and III hematological cancers who were receiving systemic treatment, such as radiation, chemotherapy, or immunotherapy, had completed within the last 6 months or had an established treatment plan including systemic treatment and had reported a score of more than 60 on the Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety scale, which indicated moderate or severe anxiety, according to the study and its listing on ClinicalTrials.gov.D
The pre-specified primary outcome researchers were looking for was a change in anxiety symptoms measured at the start of the study and at weeks 4, 8 and 12. Secondary outcomes included: changes in symptoms of depression and emotional distress; cancer-related symptoms of anxiety; wellbeing and quality of life; symptom-related stress; perceived stress; level of stress management skill and coping skill efficacy; product usability, safety and acceptability; and the global impression of change (patients’ believe in a treatment’s effectiveness) in anxiety and depression.
Patients were 80.6% female, 76.5% white, and a had mean age of 52.44 years. Those who used Attune showed “significantly greater reductions” in depression and anxiety symptoms over 12 weeks, and at the conclusion of the study a higher proportion of the Attune participants were in the “mild-none” PROMIS anxiety and depression severity categories.
Attune participants’ impression of change were more likely than those in the control group to report that they experienced improvement in their anxiety and depression symptoms.
“Anxiety and Depression Have a Huge Impact”
A third of patients with cancer, are diagnosed with comorbid anxiety and depression, while seven out of 10 suffer distressing emotional symptoms, including fear of recurrence, according to Ramiller. This added burden increases financial costs for patients by $12 billion each year.
“There are currently 18 million cancer patients and survivors living in the United States,” she said. “Most lack access to psycho-oncology care. With statistics like these, it's clear that anxiety and depression have a huge impact.”
Access, Ramiller said, is a problem, with not enough qualified, trained providers to meet the need and patients encountering barriers to in-person help including transportation or financial issues.
A digitized, evidence-based intervention, she explained, could both broaden access to quality therapeutic content and allow the limited pool of cancer-specific mental health providers to focus on more complex cases.
Looking ahead, Ramiller noted that there is a study currently in progress looking at the 6-month post-intervention time point. More research is needed to “understand what engagement and effectiveness would look like in real world settings” and to directly test potential cost savings of digitized CBSM.
Editor’s Note: Ramiller reported a consulting/advisory role with Blue Note Therapeutics.
Zion SR, Taub CJ, Heathecote LC, et al.A cognitive behavioral digital therapeutic for anxiety and depression in patients with cancer. A decentralized randomized controlled trial. J Clin Oncol. 2023;41(suppl 16):1507. doi:10.1200/JCO.2023.41.16_suppl.1507
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