November 1, 2016
Charles Bankhead

Participation in a web-based mental rehabilitation program called InSight — now sold as BrainH — led to significant improvement in cognitive symptoms reported by cancer survivors, Australian researchers reported.

Scores on a test of perceived cognitive impairment (PCI) improved by about 25% to 30% at 15 weeks in patients who participated in the intervention versus patients who did not. The improvement was maintained at a 6-month follow-up assessment. Patients’ perceptions of their mental functioning improved by a similar degree in the group assigned to the rehab program. Levels of anxiety, depression, stress, fatigue, and other outcomes also tended to improve with the intervention.

Scores on objective neuropsychological tests, however, did not differ significantly between the groups after the intervention.

Study findings were reported online in the Journal of Clinical Oncology.

“To date there has been a large unmet need for effective treatment options for cancer survivors experiencing cognitive symptoms after chemotherapy treatment,” Janette L. Vardy, MD, of the Concord Cancer Hospital and University of Sydney, and coauthors concluded. “Previous research has shown cognitive rehabilitation strategies to be feasible, with preliminary evidence of efficacy. Our large randomized controlled trial adds weight to this evidence … Importantly, there were also improvements in patient-reported outcomes, including quality of life, and reduction in stress, fatigue, and anxiety/depression.”

“The program has the potential to provide a new treatment option for patients with cancer with cognitive symptoms, where previously none existed,” the authors added.

The study was one of the largest to date addressing treatment of so-called “chemobrain” in patients with cancer and used a home-based program that did not require patients to travel to a medical center for intervention, said Patricia Ganz, MD, of the University of California Los Angeles. However, the study did not provide adequate details to know whether the intervention could be widely used at hospitals and other clinical settings.

“There are a lot of these brain-training programs out there, and most of them are for older individuals who are trying to ward off age-related cognitive decline,” Ganz told MedPage Today. “They haven’t been shown to be all that effective.”

The disconnect between the patient-reported outcomes (PROs) and objective test results raised a recurrent issue; namely, whether clinicians should rely on patient input or the objective tests.

“My view, as somebody who works in this area, is that we do have to believe our patients when they are complaining of these things,” said Ganz. “Sometimes we are able to demonstrate neuropsychological deficits at the same time. It’s like comparing clinical signs and symptoms and laboratory results. Do they both have to be going in the same direction before you believe them?”

The “believe the patients” perspective also received a nod from Halle Moore, MD, of the Cleveland Clinic.

“I don’t think we’re very good a testing for cognitive complaints, but patients sure seem to know when they have them,” she said. “That’s probably more important from the patient and survivor perspective.”

In regard to the applicability of the intervention, Moore noted that the study involved patients with early-stage disease. In that subgroup of patients, the results probably are broadly applicable. Whether they apply to patients with advanced disease remained unclear.

Vardy and co-authors reported findings from a randomized study involving 242 patients with newly diagnosed solid cancers. All had completed first-line therapy, which included chemotherapy. The study population consisted primarily of breast cancer patients, who represented 89% of the total population. Consistent with the breast cancer predominance, women accounted for 95% of the patients, who had a median age of 53.

Patients were randomized to the InSight/BrainHQ intervention plus a companion program, or standard care, as determined by the treating physician. InSight/BrainHQ comprises a series of adaptive exercises that target processing systems associated with visual input. The program’s developer, Posit Science markets it for general enhancement of mental function, not as a treatment for recognized illnesses or deficiencies.

The current study’s primary endpoint was the change in the Functional Assessment of Cancer Therapy Cognitive Function version 3, perceived cognitive impairment subscale (FACT-COG PCI) after 15 weeks, the duration of the InSight intervention. Patients randomized to the intervention completed the FACT-COG PCI at baseline, 15 weeks, and 6 months.

The results showed that patients in the intervention group had a 7.47-point reduction (improvement) in the mean FACT-COG PCI score at 15 weeks versus the standard-care control group. Mean scores declined from about 40 to 41 at baseline to 32 to 33 in the control group versus 25 to 26 in the intervention group (P<0.001).

Mean scores on patients’ perceived change in cognitive ability (PCA) increased from about 12 at baseline to 17 to 18 in the intervention group at 15 weeks versus 13 to 14 in the control group (P<0.001).

Differences in PCI and PCA remained significant at 6 months (P<0.001). Scores related to comments from others about cognitive function differed significantly at 15 weeks (P=0.04) but not at 6 months. Scores related to impact on quality of life showed a significant advantage for the intervention group at 15 weeks (P=0.03) and a trend at 6 months (P=0.06).

Study participants also completed the Cogstate neuropsychological test, and mean scores did not differ significantly between groups at 15 weeks or 6 months.