'Not Part of Routine Cancer Care,' But Should Be

3 new psychological interventions

Nick Mulcahy

June 02, 2017

CHICAGO — Three novel approaches for addressing fear in cancer patients showed statistically significant efficacy in new clinical trials, according to presenters here at the annual meeting of the American Society of Clinical Oncology (ASCO).

The three trials were featured in a press conference today, which may be indicative of some incremental progress in the status of psychological interventions in oncology, said one of the presenters, Gary Rodin, MD, a psychiatrist at the Princess Margaret Cancer Centre in Toronto, Ontario, Canada.

"I'm a little bit optimistic," he told Medscape Medical News.

However, Dr Rodin also said psychological care specifically is not duly valued by mainstream practice. "This is not seen as part of routine cancer care," he told an audience attending the Patient and Survivor Care session. Supportive care in general is not fully embraced, he also opined.

But psychological care should be a cornerstone of practice, he argued, saying it is essential to quality of life.

Agreed, said Paul Jacobsen, PhD, a psychologist at the Moffitt Cancer Center in Tampa, Florida, who acted as a discussant at the session.

Psychological symptoms need to be "recorded in the medical record like lab values," he said. Furthermore, there is a need to routinely screen patients for distress and other symptoms "to make sure help gets to those who need it most."

There are many challenges before psychological assessments and interventions are more broadly used by clinicians. For example, there are "lots of studies," but there is a lack of systematic methods to implement the best approaches, he added.

At the ASCO meeting, the three new studies were examples of solid approaches, as they employed "state-of-the-art psychological interventions," said Holly G. Prigerson, PhD, a psychologist and geriatrician at Weill Cornell Medical College in New York City, who was not involved with the research.

Dr Prigerson observed that, taken individually, the trials address three distinct phases along the cancer care continuum — from initial diagnosis and treatment to cancer survivorship, and then to end-stage cancer care.

She also commented that fear can be a double-edged sword for individuals in two of the phases — early-stage patients and cancer survivors.

"It can be helpful to the extent that it motivates health protective behaviors (e.g., cancer screening), but harmful to the extent that it erodes patients' quality of life," she pointed out.

Fear Among the Newly Diagnosed

The first trial is of a web-based "minimal-contact" stress-management intervention (STREAM) among newly diagnosed cancer patients in Switzerland.

Minimal contact refers to the fact that a psychologist only interacted with the patients via written feedback once a week during the 8-week intervention, explained lead study author Viviane Hess, MD, a medical oncologist at the University Hospital of Basel, Switzerland.

But Dr Hess also suggested that time is at a minimum for these patients.

Recently diagnosed patients are busy being treated for their cancer. There is a lack of accessibility, time, and resources for both patients and providers. The STREAM online intervention is designed for this setting, she said.

In the study, 129 participants were randomized to a cognitive therapy intervention or a wait-list control group. Cognitive therapy concepts (such as the body's reaction to stress) were taught via online weekly learning modules (written and audio) and then the therapeutic effect on the patients was assessed in follow-up questionnaires.

The majority of patients were treated in the curative setting (117; 91%). They were also mostly breast cancer patients (71%) and female (84.5%).

After 8 weeks of STREAM, quality of life was significantly increased (P = .007; adjusted for baseline-distress) and distress significantly lowered (P = .03) in the intervention group compared with the wait-list control.

However, on the downside of the data, Dr Prigerson observed that there was a lack of efficacy on symptoms of depression or anxiety.

She also had a couple of suggestions for the Swiss developers.

"It might be useful to improve efficacy with respect to diagnosable mental disorders or symptoms of them (e.g., Generalized Anxiety Disorder or Major Depressive Disorder). This would facilitate insurance coverage to support therapist involvement," she said, referring to any would-be application in the United States.

She also believes that removing the therapist and fully automating STREAM might be more practical. "A version without the therapist might be developed and tested for greater dissemination," she said. "This is a potentially scalable psychological intervention."

Conquer Fear

The second study addressed the all-too-common worry about cancer recurrence in patients who receive curative therapy.

This was a phase 2 randomized, controlled trial conducted in Australia, in which  breast, colorectal, and melanoma cancer survivors were randomized to a novel psychological intervention, known as Conquer Fear (n= 121), or the control ""Taking It Easy'" relaxation training control arm (n= 101) to reduce clinical levels of fear of cancer recurrence.

The patients' survivorship ranged from 2 months to 5 years.

Conquer Fear included five sessions incorporating attention training, detached mindfulness, challenging unhelpful metacognitions, values clarification, and psycho-education. It is a novel approach and not yet available in clinical practice. In both arms, each face-to-face session with a patient was 60- to 90-minutes long and took place over 10 weeks.

Among other things, Conquer Fear teaches patients to accept the inherent uncertainty of whether or not the cancer will come back.

The primary endpoint was the reduction in fear of cancer recurrence inventory (FCRI) score immediately after intervention completion. The patients in the Conquer Fear arm had a significantly greater median reduction in score (18.1 points) than those in the control relaxation group (7.6 points), immediately after the intervention. The difference in change (95% confidence interval) was statistically significant (-10.5; P < .001).

The result is considered clinically important, said lead study author Jane Beith, MD, PhD, a medical oncologist at the University of Sydney, Australia, who also spoke at the meeting press conference. She developed the Conquer Fear intervention with colleagues.  

FCRI scores continued to decrease over time, with a significant difference between groups at 3 months (P = .02) but not at 6 months.

Dr Prigerson described the effect of Conquer Fear as statistically significant but nonetheless "moderate" on fear of recurrence relative to the relaxation control arm.

"It would likely prove effective in US cancer survivor samples," she said. However, paying for a therapist in five extended sessions (60 to 90 minutes) "is likely to prove a challenge to its sustainability," she added.

CALM

In the final study, the needs of terminal cancer patients were addressed.

In total, 305 patients with advanced cancer were randomized to a brief psychological intervention, called Managing Cancer and Living Meaningfully (CALM), or to usual care.

CALM supports exploration in four broad domains: symptom management and communication with healthcare providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality, Dr Rodin said.

The program takes place in 3 to 6 individual sessions delivered over 3 to 6 months.

That time period is "brief," said Dr Prigerson. But she also worried it is not brief enough for some of these late-stage cases.

"Given that many stage IV cancer patients are likely to be unable to engage meaningfully in 45-minute therapy sessions, and many will not survive 3 to 6 months from diagnosis, a more streamlined version of CALM might be helpful to the more debilitated cancer patients who are closer to death," she said.

But Dr Prigerson liked the content. "It is unusual in that it addresses end-of-life issues explicitly, including interpersonal relationships and existential concerns," she added.

Patients seemed to have liked the content too. Compliance with the intervention was 77.5% and attrition was 28% (16% deceased, only 8% lost to follow-up, 4% withdrew).

The CALM group reported less severe depressive symptoms compared with usual care at 3 and 6 months. Among those patients depressed at baseline, a "clinically meaningful" reduction in depressive symptoms was found in 52% of the CALM group and 33% of the usual-care group at 3 months (and 65% vs 35% at 6 months), said Dr Rodin. Both of these were statistically significant, he said.

Dr Prigerson observed that there was a "somewhat small effect" at 3- and 6-month follow-ups, despite statistical significance.

She also said, "There is an uphill battle against depression as cancer progresses to an advanced stage." And this showed  in the study, as 13% of patients in the experimental arm developed depression while on CALM (which still compared favorably with the 30% onset rate of depression among those getting usual care).

Dr Rodin seemed pleased with the results.

"CALM is an effective intervention that alleviates distress in individuals with advanced or metastatic cancer and helps them to address [and] manage the profound and practical problems they face," he said.

A global network in 20 countries is now being established to train health professionals in the delivery of CALM, Dr Rodin also told reporters.

Conquer Fear was funded by Cancer Australia, beyondblue, and the National Breast Cancer Foundation. CALM was funded by the Canadian Institutes of Health Research. STREAM was funded by the Swiss National Science Foundation and Cancer Research Switzerland.

Viviane Hess, MD reported financial relationships with CSL Behring. The other authors disclosed no relevant financial relationships. Dr Schilsky has ties to AstraZeneca, Bayer, Bristol-Myers Squibb, Genentech/Roche, Lilly, Merck, and Pfizer. Dr Jacobsen disclosed financial ties with Pfizer.

2017 annual meeting of the American Society of Clinical Oncology (ASCO). Abstracts LBA10000 (Conquer Fear study), LBA10001 (CALM study), and LBA10002 (STREAM study) were presented June 2, 2017.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

For more from Medscape Oncology, follow us on Twitter: @MedscapeOnc

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