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Participants in the RESTORE study, results of which were presented this weekend at ASCO, saw “significant improvements” in depression and anxiety symptoms after using the Attune app.
Patients with cancer saw significant improvements after utilizing a digital software application designed to improve symptoms of depression and anxiety, according to the findings of a new study presented this weekend at the 2023 American Society of Clinical Oncology Annual Meeting in Chicago.
“I think what we were most excited about with these findings is that it really shows the potential that something like digitized CBSM (cognitive behavioral stress management) has 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 against 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 participating patients with non-metastatic stage 1, 2 and 3 hematological cancers who were receiving systemic treatment such as radiation, chemotherapy or immunotherapy, had completed within the last six 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.
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 four, eight 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.
Participating patients were 80.6% female, 76.5% white and a mean age of 52.44. 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.
A third of patients with cancer, Ramiller said, are diagnosed with comorbid anxiety and depression, while seven out of 10 suffer distressing emotional symptoms, including fear of recurrence. 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 six-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.
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