Results Summary

What was the research about?

Cancer survivors often have insomnia. Insomnia causes patients to have trouble falling or staying asleep. Medicines that treat insomnia can cause side effects, such as feeling sluggish or having memory problems. Because of the side effects, some patients choose to treat insomnia without medicine.

In this study, the research team compared two non-medicine treatments for insomnia:

  • Acupuncture involves inserting small needles into different parts of the body to treat health problems.
  • Cognitive behavioral therapy for insomnia, or CBT-I, helps teach patients how to deal with thoughts that keep them awake. CBT-I also helps patients follow healthy sleep habits and change behaviors that make insomnia worse.

The research team wanted to learn if one treatment worked better to reduce insomnia among cancer survivors. They also looked at pain, fatigue and anxiety, symptoms of depression, and quality of life.

What were the results?

Overall, both acupuncture and CBT-I reduced patients’ insomnia. CBT-I reduced insomnia more than acupuncture. The research team also found that CBT-I worked better than acupuncture to reduce insomnia for patients with specific traits. These patients included men and patients who were white, highly educated, and without pain at the start of the study.

Acupuncture reduced pain more than CBT-I at the end of treatment. Patients who received acupuncture or CBT had the same amount of improvement in

  • Fatigue and anxiety
  • Symptoms of depression
  • Quality of life

Who was in the study?

The study included 160 cancer survivors with insomnia. Of these, 71 percent were white, 28 percent were black, and 2 percent were other races. The average age was 62, and 57 percent were women. Patients lived near cancer centers in Philadelphia and New York City. All had finished cancer treatment.

What did the research team do?

The research team assigned patients, by chance, to one of two groups. In the first group, patients received one 60-minute and nine 30-minute acupuncture treatments. In the second group, patients received one 60-minute and six 30-minute CBT-I sessions. Patients in each group received treatment for eight weeks.

Patients filled out surveys before treatment and again at 8 and 20 weeks after treatment. The surveys asked patients about their insomnia. In addition, the surveys asked about pain, fatigue and anxiety, symptoms of depression, and quality of life.

Eight cancer survivors who had insomnia gave input on the study.

What were the limits of the study?

Because patients knew what treatment they were receiving, the team can’t be sure that people’s beliefs and expectations didn’t influence the findings. The study included only cancer survivors. Results may differ for patients with other health problems.

Future research can look at how to tailor insomnia treatment for patients with specific traits, such as patients with advanced cancer.

How can people use the results?

Cancer survivors and their doctors can use the results when considering ways to treat insomnia without medicine.

Final Research Report

View this project's final research report.

More About This Research

PCORI Stories

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.

Videos

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 Summary

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

View the COI disclosure form.

Stories and Videos

Peer-Review Summary

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

Project Information

Jun James Mao, MD, MSCE
Sloan Kettering Institute for Cancer Research^
$1,905,092
10.25302/07.2020.CER.140314292IC

Key Dates

39 months
September 2014
October 2019
2014
2019

Study Registration Information

^Jun James Mao was affiliated with the University of Pennsylvania when this project was funded.

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Last updated: October 20, 2021