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ASCO Perspective
“We know that sleep is critical to the health of patients with cancer, from active cancer care through survivorship. This research reinforces the understanding that there are a variety of effective, non-medical tools, including psychological counseling and acupuncture, that can improve sleep and insomnia beyond traditional medicines, which can cause side effects that may diminish quality of life in other ways,” said ASCO President Bruce E. Johnson, MD, FASCO.

ALEXANDRIA, Va. – A Patient-Centered Outcomes Research Institute (PCORI)-supported randomized clinical trial of cancer survivors showed that eight weeks of either acupuncture or cognitive behavioral therapy for insomnia (CBT-I) decreased the severity of insomnia among cancer survivors, though improvements were greatest among patients receiving cognitive behavioral therapy. The study will be presented at the upcoming 2018 ASCO Annual Meeting in Chicago.

To find a therapy to compare with CBT-I, the researchers consulted a group of patient advisors who had cancer and who were knowledgeable about how insomnia could impact their health. Additionally, a survey of cancer survivors found that survivors preferred a natural, non-medicinal approach to treating insomnia. Based on this feedback, and results from other sleep studies that showed it could beneficial, acupuncture was deemed a reasonable comparison to be used in this trial.

The survivors in the trial had completed cancer treatment, and the mean time since cancer diagnosis was about six years. The survivors had received treatment for breast, prostate, head and neck, hematologic, and colorectal cancer. In addition, 6% had received treatment for more than one type of cancer.

All trial participants had been clinically diagnosed with insomnia by research staff through structured clinical interviews and were randomly assigned to receive either CBT-I or acupuncture (needles placed at a pre-determined set of points on the body shown to influence sleep, pain, and depression) for eight weeks.

The participants who received CBT-I worked with a therapist to re-establish a restorative sleep schedule by:

• Reducing the amount of time in spent in bed
• Limiting activities performed in bed to only sleep and sexual activity
• Modifying unhelpful beliefs about sleep
• Promoting good sleep hygiene (avoiding activities that included light from tablets and cellphones, eating too late, and performing vigorous activities; they also set a regular sleep schedule)

Reduction in insomnia severity, measured by the Insomnia Severity Index (ISI), from study entry to week 8 (end of treatment), was the primary study outcome. Survivors were also reassessed 20 weeks after having started the trial. The ISI is a questionnaire that asks people to rate the severity of insomnia problems, such as difficulty falling asleep and staying asleep, and the impact of insomnia on their daily functioning and quality of life. The ISI score ranges from 0-28, with scores 0-7 considered as no clinically significant insomnia, 8-14 mild insomnia, 15-21 moderate insomnia, and 22-28 severe insomnia. At the beginning of the trial, 33 survivors had mild insomnia, 94 had moderate insomnia, and 33 severe insomnia.

Key Findings
CBT-I was the more effective treatment overall: After eight weeks, insomnia severity scores fell 10.9 points, from 18.5 to 7.5 for those who received CBT-I vs. 8.3 points for those who received acupuncture treatments, from 17.55 to 9.23. Among people with mild insomnia at the start of the trial, far more had an improvement with CBT-I than with acupuncture (85% vs. 18%). Participants who started the trial with moderate to severe insomnia had somewhat similar response rates to CBT-I vs. acupuncture (75% vs. 66%). All survivors maintained improvement in insomnia up to 20 weeks after the start of the trial.

Next Steps
This trial was a comparison between two interventions and determined which approach provided a greater relief of insomnia. Future research will focus on how best to deliver effective treatments to more diverse groups of cancer survivors to improve sleep management.

This study received funding from the Patient-Centered Outcomes Research Institute (PCORI).

Study at a Glance

View the full abstract.

For your readers:

• Sleeping Problems: Insomnia
• Types of Complementary Therapies

Disclosures for Bruce E. Johnson, MD, FASCO: Stock and Other Ownership Interests with KEW Group; Honoria from Merck and Chugai Pharma; Consulting or Advisory Role with Novartis, AstraZeneca (Inst.), KEW Group, Merck, Transgene, Clovis Oncology, Genentech, Lilly (Inst.), Chugai Pharma, Boehringer Ingelhelm and Amgen; Research Funding with Novartis; Patents, Royalties and Other Intellectual Property with royalties from Dana-Farber Cancer Institute; Expert Testimony with Genentech.

ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.

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