Gary Rodin, MD
The intervention, known as CALM, yielded a clinically meaningful 52% reduction in depressive symptoms after 3 months among participants who had the intervention, compared with a 33% reduction in a control group receiving usual care, reported Gary Rodin, MD, the study’s lead author, presenting the findings of this randomized controlled trial during a presscast at the 2017 ASCO Annual Meeting.
At 6 months of follow-up, the benefit was even greater, with a 65% reduction in depressive symptoms in those receiving the CALM intervention versus 35% in the control group. Additionally, CALM participants who were not depressed at baseline were less likely to become depressed at 3 months, compared with usual care controls (13% vs 30%, respectively).
“This intervention addresses both the practical problems these patients face, which are many, including, ‘How do I manage my pain and my symptoms?,’ but also the profound problems and issues that people face: ‘What is the meaning of my life having a terminal diagnosis?’” explained Rodin, who heads the Department of Supportive Care at the Princess Margaret Cancer Centre in Toronto, Canada where the trial was conducted.
Although these issues and challenges are predictable and known to cause a lot of distress, he said, “There hasn’t been a routine or systematic approach to help people with these problems.”
CALM is a novel psychotherapy intervention designed to fill that void. Rodin said the program was evaluated in 305 patients with advanced cancer evenly randomized to either CALM (n = 151) or usual care (n = 154). The Patient Health Questionnaire-9 was used to measure depressive symptoms.
Usual care participants received routine oncology treatment and follow-up, as well as clinic-based distress screening. About one-third of the control group received some specialized psychosocial oncology care, but less than 10% received structured or semi-structured psychotherapy.
Patients in the CALM group had 3 to 6 psychotherapy sessions delivered by trained therapists to support reflection in 4 broad domains. The first domain emphasizes symptom management and communication with healthcare providers, including treatment decisions. Second, are the changes in self-concept, which Rodin elaborated involves how patients feel about themselves, having a disease that affects every aspect of their physical being, as well how their relationships change, for example, the need to depend on others. The third domain centers on spirituality and patients’ sense of meaning and purpose in life.“That’s something we all need to think about,” Rodin noted, “but having a disease with a prognosis of 12 to 18 months heightens that dilemma.” Finally, the intervention is aimed at helping patients deal with their fears and concerns about the future.
“What we found is that we had a significant effect on the primary outcome [depressive symptoms],” Rodin reported, “and these effects were actually strengthened at 6 months. We also found that not only did CALM treat depression, it also had a preventive effect, so that participants who were not depressed at baseline were less likely to be depressed at 3 months.”
A number of additional secondary outcomes favored the study intervention, Rodin added, including:
- Talking and feeling understood about the impact of cancer
- Managing feelings about cancer and the future
- Communicating with the healthcare team and with the family
- Dealing with changes in relationships as a result of cancer
- Clarifying values and beliefs
- Preparing for the end of life
ASCO Expert Don S. Dizon, MD, FACP, said these data, “add much more importance to the concept of paying attention to patients’ symptoms beyond cancer-specific outcomes—that we can do things to improve their quality of life; patients who are facing advanced disease still need our help.”
Rodin G, Lo C, Rydall A, et al. Managing cancer and living meaningfully (CALM): a randomized controlled trial of a psychological intervention for patients with advanced cancer. J Clin Oncol. 2017;35 (suppl; abstr LBA10001).