June 2017 Edition Vol.11, Issue 6

Patient-Reported Outcomes (PRO) Improve the Lives of People with Cancer

By Lynne Lederman, PhD

For the first time, the use of patient-reported outcomes (PRO) for symptom monitoring by patients with cancer has been shown to increase survival. At this year’s ASCO annual meeting, results of a randomized trial of PRO for symptom monitoring during routine cancer treatment vs routine care were presented during the plenary session.1

“Perhaps the most striking finding in this trial is a significant benefit in overall survival,” said Ethan M. Basch, MD, The University of North Carolina at Chapel Hill, who presented the trial results.

The PRO study tested the hypothesis that proactive symptom monitoring during chemotherapy would improve symptom management, leading to better clinical outcomes.

Patients receiving chemotherapy for metastatic breast, lung, genitourinary, or gynecologic cancer at a single center were randomly assigned to the intervention arm or control arm, stratified by level of prior computer use, and randomly assigned 2:1 for those without prior computer experience.

In the intervention arm, patients used a web-based system to self-report 12 common symptoms prior to clinic visits and between visits. The control arm was “standard” symptom monitoring, consisting of usual discussions at visits, or calls between visits at the discretion of patients.

Patients were enrolled from June 2007 through January 2011 (N=766). The overall survival (OS) analysis was conducted in June 2016 after 67% of participants had died, at a median follow-up of 7 years.

Compared with the standard symptom monitoring arm, 31% more patients in the self-reporting arm experienced statistically significant quality of life (QoL) benefits (P<.001) and 7% fewer patients visited the ER (P=.02). The median OS was 5.2 months longer in the self-reporting arm vs the standard monitoring arm: 31.2 months vs 26.0 months (P=.03), respectively.

Dr. Basch looked at three potential “mechanisms of action” to explain the survival benefit:

  • Proactive symptom monitoring prompted nurses to take clinical action in response to most alerts they received, keeping patients out of the ER
  • Patients in the self-reporting arm experienced better physical functioning and self-care, which has been shown to be associated with better survival
  • Symptom monitoring should control chemotherapy side effects, enabling more intensive and longer duration of cancer treatment

In this study, patients in the self-reporting arm were able to receive chemotherapy for 2 months longer duration on average than those receiving standard care: (8.2 mos vs 6.3 mos, respectively; P=.002).

Monika K. Krzyzanowska, MD, MPH, Princess Margaret Cancer Centre, Toronto, Canada, who discussed the study called the findings “practice changing” and said that PRO-active symptom monitoring “should be considered the new standard of care” during chemotherapy treatment.

Although there is more evidence to come from other trials, Dr. Krzyzanowska said, “I am not sure I can wait for more evidence.”

Dr. Basch noted that limitations of this study are that it was conducted at a single center, and was started over a decade ago. A national trial funded by PCORI and administered through the Alliance Foundation will further explore these findings using more user friendly online tools and mobile technology.

Dr. Basch told OBR, “Symptom management is an essential component of the practice of oncology, and clinicians work hard to monitor and manage patients’ symptoms. This study shows that despite our best efforts, we can do better. Communication barriers exist that can be overcome using simple tools, like this symptom monitoring software.”

 

Psychologic Support Improves QoL and Lowers Distress After Diagnosis

Three other late-breaking abstracts at ASCO described the use of psychologic interventions to improve patient QoL across the continuum of cancer care from initial diagnosis to end of life.

Viviane Hess, MD, University Hospital Basel, Medical Oncology, Basel, Switzerland presented the results of the STREAM trial—a web-based stress management program for newly diagnosed cancer patients (NCT02289014).

The study aim was to assess the feasibility and efficacy of a therapist-guided online stress management program for newly diagnosed cancer patients undergoing treatment. The rationale was that a diagnosis of cancer is associated with a high level of distress; in turn, chronic distress negatively affects long-term physical and mental health, treatment tolerance, and adherence to treatment.

STREAM tested an online, therapist guided stress reduction program consisting of 8 weekly modules requiring 1 to 2 hours a week, with weekly written contact with a psychologist for newly diagnosed patients who had basic computer skills.

Patients were randomly assigned to STREAM (n=65) or to a wait-list control (n=64) that had access to STREAM at the primary assessment time point. The primary endpoint was QoL. Secondary endpoints were distress and mood at primary assessment. Patients had a median age of 52 years, 71.3% had breast cancer, and 76% were highly distressed at baseline, indicating the study reached a target population in need of support.

The median duration for the intervention group was 11.7 weeks; 80% completed 6 of 8 modules, 75.4% completed all 8. Therapist’s mean time was 13.3 minutes per patient per week.

QoL, the primary endpoint, improved in the intervention group, which was statistically and clinically significant. At the primary assessment, distress, but not mood, also improved in the intervention group.

 

Psychologic Intervention Lowers Fear of Cancer Recurrence

Jane Beith, MD, PhD, Chris O’Brien Lifehouse, Sydney, Australia, presented the long-term results of a phase 2 randomized controlled trial of a psychological intervention (Conquer Fear) to reduce clinical levels of fear of cancer recurrence (FCR) in breast, colorectal, and melanoma cancer survivors.3

FCR is experienced by the majority patients, as well as their caregivers, and tends to remain stable over the course of cancer survivorship. High FCR is associated with poorer QoL and greater distress, lack of planning for the future, avoidance of or excessive follow-up, and greater health care utilization, and affects patient mood and relationships.

The Conquer Fear intervention, an individual, face-to-face therapy with a clinical psychologist or psychiatrist to focus on “meta-cognitions” or worrying about worrying, was evaluated for reducing clinical FCR levels compared with a non-specific attention control intervention (Taking It Easy).

Conquer Fear was delivered in 5 sessions of 60 to 90 minutes each over 10 weeks, and included planning for the future, focus on the moment, control over attention focus, meta-cognitive therapy, and a contract for appropriate follow-up. Taking It Easy was an active comparator because it included relaxation techniques that have been shown to be beneficial.

Nearly all patients were female with a diagnosis of breast cancer and a median age of 53 years; 121 were assigned to Conquer Fear, 101 to Taking It Easy. About two-thirds of each group completed all 5 sessions of their intervention.

FCR, the primary outcome, decreased for both groups, and was significantly lower for the Conquer Fear arm at post intervention (P<.001), at 3 months (P=.02), and at 6 months (P=.02). FCR severity index was lower in favor of Conquer Fear at all time points.

All participants experienced improvements for the secondary outcomes of cancer-related anxiety, general anxiety, QoL, and meta-cognitions, which were significantly lower for Conquer Fear only immediately post therapy.

Future plans include an economic evaluation as well as research exploring more accessible and less costly formats, e.g., online, group, or community delivered interventions.

 

Psychologic Intervention Relieves Distress in Advanced Cancer

Gary Rodin, MD, Princess Margaret Cancer Centre, Toronto, Ontario, Canada, presented the results of Managing Cancer and Living Meaningfully (CALM), a randomized, controlled trial of a psychological intervention for patients with advanced cancer.

CALM is a novel, brief, supportive-expressive psychotherapy intervention consisting of 3 to 6 sessions over 3 to 6 months with a specially trained cancer clinician focused on four broad domains: symptom management and communication with healthcare providers; changes in self and relationships with close others; spirituality and sense of meaning and purpose; future-oriented concerns, hope, and mortality.

This study assessed the effectiveness of CALM in preventing and alleviating distress in patients with advanced and metastatic cancer who had a prognosis of 12 to 18 months. The primary outcome was severity of depressive symptoms. Secondary outcomes included: QoL, emotional support from healthcare providers, death anxiety, generalized anxiety, and spiritual well-being.

Patients were randomly assigned to CALM plus usual care (n=151) or usual care (n=154), with follow-up assessments at 3 and 6 months. Median patient age was 59.1 years; 60% were female, 84% were white.

The CALM intervention resulted in significant reduction of depressive symptoms compared with usual care (52% in the CALM group vs 33% for usual care at 3 months, P=.04; 64% in the CALM group vs 35% for usual care at 6 months, P=.01) and had a preventive effect, i.e., if a patient didn’t have depressive symptoms at the start of the trial they were less likely to develop them during the trial.

Secondary outcomes which favored CALM at 3 and 6 months included greater end-of-life preparation, greater opportunity to talk about future-oriented concerns and feel less frightened, and greater ability to express and manage feelings. Additional outcomes favoring CALM at 6 months included better ability to talk and feel understood about how cancer has affected their life, better ability to explore ways of communicating with the healthcare team and family, better ability to deal with changes in relationships because of cancer, and greater clarification of values and beliefs. All effects were strengthened at 6 months.

Dr. Rodin said that a global network is now being established to train health professionals in the delivery of CALM and to evaluate its effectiveness in diverse clinical and cultural settings.

 

In Conclusion

ASCO Expert Harold J. Burstein, MD, PhD, called the self-reporting study exciting and compelling. His immediate questions included how to integrate these interventions into practice. An additional barrier is that current reimbursement models are not aligned around this model of care.

Paul B. Jacobsen, PhD, National Cancer Institute, Bethesda, Maryland, who discussed the presentations of STREAM, Conquer Fear, and CALM, observed that despite evidence, many patients who could benefit from psychologic interventions do not receive them and noted that there needs to be a focus on how to implement these interventions that have been shown to be effective.

Dr. Jacobsen expects to see more studies using online recruitment like STREAM, although in the United States there is still a digital divide. He was impressed by the rate of completion of the STREAM intervention speculating that the minimal therapist contact may have helped.

 

 

References

  1. Basch E, Deal AM, Kris MG, et al. Symptoms monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 20165;34:557-565.
  2. Hess V, Grossert A, Alder J, et al. Web-based stress management for newly diagnosed cancer patients (STREAM): A randomized, wait-list controlled intervention study. J Clin Oncol. 35, 2017 (suppl; abstr LBA10002).
  3. Beith JM, Thewes B, Turner J, et al. Long-term results of a phase II randomized controlled trial (RCT) of a psychological intervention (Conquer Fear) to reduce clinical levels of fear of cancer recurrence in breast, colorectal, and melanoma cancer survivors. J Clin Oncol. 35, 2017 (suppl; abstr LBA10000).
  4. 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. 35, 2017 (suppl; abstr LBA10001).

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