This research project is in progress. PCORI will post its findings here within 90 days after our final review is complete. In the meantime, results have been published in peer-reviewed journals, as listed below.
Background: Early detection and treatment advances have resulted in greater numbers of Americans joining the population of cancer survivors, which now number 13.7 million. Between 30 and 50 percent of people treated for cancer experience insomnia, reporting that sleep difficulty is one of most significant barriers to resuming normal function. Considering the prevalence, significance, and impact of insomnia, cancer patients require information about treatment options to make timely and informed decisions. Acupuncture and cognitive behavioral therapy (CBT) are both widely available and commonly used non-medication-based treatments for insomnia. Acupuncture and CBT have both demonstrated efficacy and are increasingly available to patients; however, it remains difficult for patients to decide which of these two treatments will best address their insomnia and co-morbid symptom burden.
Objectives: To compare the effectiveness of acupuncture versus CBT for insomnia (CBT-I) and other symptoms among cancer survivors and identify how patient characteristics (e.g., sex), clinical factors (e.g., pain), and psychological attributes (e.g., treatment preference and outcome expectancy) influence treatment outcomes.
Methods: Participants will be randomly assigned to an eight-week regimen of acupuncture or CBT-I. They will complete symptom assessments at baseline, mid-treatment, immediately post-treatment, and three-month follow-up.
Patient Outcomes: The primary outcome will be patient-reported insomnia severity measured by the validated Insomnia Severity Index. Additional patient outcomes will include daily sleep diaries and patient-reported outcomes of pain, fatigue, anxiety, depression, and quality of life. Potential moderators of treatment outcome will also be assessed.
Patient and Stakeholder Engagement: Our patient partner and stakeholder advisory panel has helped to formulate the research questions, identify the two interventions, determine how best to recruit and retain participants, and choose the most relevant outcomes. This panel will continue to advise on the study conduct and analysis and help plan dissemination efforts. Two of our patient partners will also serve as co-investigators in the study.
Anticipated Impact: The study results will help cancer survivors and their caregivers make informed and evidence-based decisions about how to most effectively address cancer-related insomnia and co-occurring symptoms. Thus, this study has the potential to improve symptom burden and well-being for millions of individuals whose lives are affected by cancer.
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.
^Jun James Mao was affiliated with the University of Pennsylvania when this project was funded.