1211 GMT January 20, 2019
However, the intervention did not significantly reduce depression or improve quality of life compared with standard care, healio.com reported.
“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 six 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 three months.
Change in PHQ9 score from baseline to three months served as the primary endpoint. Changes in other questionnaire scores at three 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 three months in PHQ9 and Global Health Status/QOL scale between both groups.
“It was surprising that depression scores dropped between baseline and three 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 three months. This is great, but bad for us because we did not expect this would happen when we designed our study.”
Until now, there has been limited evidence addressing psychological distress. This is the first randomized trial of a psychological intervention in ovarian cancer. It will be important to see what the outcomes will be long term beyond three months. It is important to have an intervention that is standardized, and the approach used in this study was very good in this sense. Blagden noted the minimal cost of the study. In order to conduct clinical trials, we need adequate funding and resources to obtain meaningful data. We also need better validated tools to measure quality of life and fear of progression. This study added a framework for study design for others to come. Are we ready for routine psychological assessment and interventions in oncology practice? The answer to this is unclear. What is clear is that we need more survivorship research, and collaborative efforts for this research are required.