Results Summary and Professional Abstract
|This project's final research report is expected to be available by April 2020.|
|Article Highlight: Thirty to 50 percent of patients with cancer experience insomnia, often caused by medications or anxiety about their diagnosis. This PCORI-funded project found that patients like these might see improvement in quality of sleep and quality of life through nondrug treatments like acupuncture and cognitive behavioral therapy (CBT). Researchers say in an article in the Journal of the National Cancer Institute that while both therapies seem to help, CBT was more effective.|
Dealing with Cancer Symptoms and Treatment Side Effects
A narrative on this project, which looks at how patients and care providers best manage severe symptoms, as well as troubling side effects of their cancer treatment.
|Watch this video with audio narration|
Learning From Patient Advisors
Jun Mao shares how patient partners have positively impacted his study, which hopes to improve outcomes for cancer survivors with insomnia.
Helping Cancer Survivors Sleep (right)
Because many cancer patients experience disrupted sleep, a PCORI-funded study is testing two nondrug treatments for insomnia.
Patient-Centered Outcomes Research
Jodi MacLeod and Jun Mao share how they viewed clinical research before collaborating on a study to improve outcomes for cancer survivors with insomnia.
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- The reviewers asked how the researchers selected the two treatments as methods to test and suggested discussing other possible choices in the background section. The researchers responded that only a limited number of drug-free interventions exist to treat insomnia. The researchers said they had previously shown that mindfulness-based stress reduction is inferior to CBT-I in treating insomnia immediately following cancer treatment. After consulting with patient advisors and discussing other options, the study’s advisory panel decided that comparing CBT-I and acupuncture would provide the most information.
- The reviewers disputed the claim that acupuncture is an effective intervention for insomnia, since this two-group study showed that CBT-I was more effective than acupuncture. The researchers said they certainly agree that CBT-I was more effective overall but said the effects for acupuncture exceeded what would be considered a clinically meaningful change in insomnia symptoms. The researchers insisted that this level of change would not occur in a no-treatment condition, based on past studies.
- The reviewers objected to study conclusions indicating that although in most areas cognitive behavioral therapy for insomnia (CBT-I) fared better than acupuncture on insomnia symptoms, there were specific patient subgroups where acupuncture was at least as effective as CBT-I. The researchers noted that the study was not powered to test for subgroup differences, and the one subgroup showing strong results for acupuncture was actually one of about 12 exploratory analyses. The researchers acknowledged the lack of statistical power for subgroup analyses but stated that they made a clinical rather than statistical interpretation of the results. The specific subgroup analysis, involving a split into clinically mild versus moderate or severe insomnia was meant to make the results easier to interpret by patients than a continuous insomnia severity score would be. Moreover, the researchers indicated that when they submitted the original report, they had not completed other secondary analyses, but the revised report included all the secondary analyses that they had planned. With additional revisions, the researchers acknowledged that the insomnia severity analysis was an exploratory finding and so they de-emphasized it in the report.
Conflict of Interest Disclosures
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Complementary and Alternative Medicine
Other Clinical Interventions
^Jun James Mao was affiliated with the University of Pennsylvania when this project was funded.