Psychosocial therapy reduces fear of disease progression among women with ovarian cancer
MUNICH — A psychological support intervention significantly reduced fear of progression among women with ovarian cancer, according to randomized study results presented at European Society for Medical Oncology Congress.
However, the intervention did not significantly reduce depression or improve quality of life compared with standard care.
“Although the recruitment goal and hypothesis of this study were not met, our findings show — for the first time in a randomized clinical setting — that fear of progression is responsive to therapy,” Sarah Blagden, PhD, associate professor of experimental cancer therapeutics in the department of oncology at University of Oxford in the United Kingdom, said during a presentation.
Many women with ovarian cancer experience high levels of psychological distress at diagnosis, as well as during treatment and follow-up. More recently, fear of progression has been described as “the new kid on the block” and is emerging as an important concern for these patients, Blagden said.
“However, there are poor tools at the moment and bad cutoffs to assess this concern,” she said. “We wanted to know what the main psychological concerns of our ovarian cancer patients are, what support they need, how it can be delivered and how effective it is.”
Blagden and colleagues assessed the effect of a brief course of psychological support on self-reported depression, fear of progression, and quality of life among 63 women (mean age, 59 years) treated with chemotherapy for primary or relapsed ovarian cancer.
Researchers randomly assigned 107 women 1:1 to a psychological intervention (n = 54) or a control group (n = 53). The intervention consisted of three standardized, 90-minute sessions of psychological support that occurred 6 to 12 weeks after chemotherapy. Controls received standard-of-care support where indicated.
The final analysis included 63 patients (intervention, n = 32; control, n = 31) who completed Patient Health Questionnaire-9 (PHQ9), fear of progression-Q-SF, EORTC QLQ C30, and OV28 questionnaires at baseline and at 3 months.
Change in PHQ9 score from baseline to 3 months served as the primary endpoint. Changes in other questionnaire scores at 3 months served as secondary endpoints.
Blagden and colleagues hypothesized the intervention would reduce depressive scores by a factor of three compared with controls. However, results showed comparable improvements from baseline to 3 months in PHQ9 and Global Health Status/QOL scale between both groups.
“It was surprising that depression scores dropped between baseline and 3 months ... in both groups, regardless of the intervention,” Blagden said. “No one has ever tracked depression scores among patients in a longitudinal way. It appears that immediately after chemotherapy, patients are actually improving in terms of their depression levels toward 3 months. This is great, but bad for us because we did not expect this would happen when we designed our study.”
Researchers did observe a significant improvement in fear of progression scores at 3 months only among women assigned the intervention (intervention effect = -5.2; 95% CI, -8.45 to 1.9; P=.003).
“Other quality-of-life measures were not significantly altered,” Blagden said. “We are continuing to collect further data, because these findings may change as we move out from the initial study time period.”
Blagden noted several study limitations, including the lack of site monitoring due to the minimal study costs; lack of information about disease stage; and the significant dropoff in survey completion among enrolled patients. – by Jennifer Southall
Blagden S, et al. Abstract 9400. Presented at: European Society for Medical Oncology Congress; Oct. 19-23, 2018; Munich.
Disclosures: Blagden reports serving as director of RNA Guardian Ltd; advisory board roles with Clovis, Ellipses and Novartis; and research funding from NuCana. Please see the abstract for all other authors’ relevant financial disclosures.