Easily Implementable Program Addresses Poor Sleep in Cancer Survivors

Since up to 30% of patients with cancer experience insomnia, even years later, a team from Dana Farbar Cancer Institute has developed a stepwise approach to improve sleep and designed for ease of implementation in any practice setting.

With Eric Zhou, PhD, and Charles L. Shapiro, MD

Insomnia is likely to adversely affect many cancer survivors long after completing treatment. Poor sleep—one of the most commonly experienced difficulties of cancer survivorship, affects up to 30% of patients—has a lasting impact on their overall health and wellbeing.1,2

As such, when thyroid cancer patients present with complaints of chronic sleep issues, there is good reason to heed this consequence since insomnia is linked to a wide range of medical concerns in those who are living with cancer in remission or cured (as well as the population at large).3

Improving Sleep with a Brief 2-Step CBT Program  

Now, researchers from the Dana-Farber Cancer Institute have developed a novel, stepped-care behavioral treatment program that greatly helps patients who have battled a variety of cancers with sleep difficulties.4

The first step requires only an hour; and for those patients who are not fully responsive, the second step requires three hours.4 Intentionally, the program was designed to be easily implemented in both primary care settings and by endocrinologists, said study author Eric Zhou, PhD, who is on the sleep medicine faculty at Harvard Medical School and a psychologist at the Dana-Farber Cancer Institute in Boston Massachusetts.

However, awareness of the problem is needed first. "It's shocking how little sleep is discussed" by most clinicians, Dr. Zhou told EndocrineWeb. "Despite its significant impact, sleep has been vastly ignored."

Dana Farber Researchers Assess Efficacy of 2-Step Sleep Treatment Method   

The research team enrolled 51 patients who had undergone successful treatment for some form of cancer, and attained an elevated Insomnia Severity Index (ISI) score of 12 or over.

The Insomnia Severity Index (ISI) is the most commonly used measure to assess sleep disorders in clinical research,5 and it has been validated specifically in cancer survivors.6  

The ISI is a simple, seven-question survey that queries patients about:

  • Do they have any difficulty falling sleep?
  • Are they ability to stay asleep once they fall asleep?
  • Do they have the experience of waking up too early?
  • How satisfied are they with their current sleep pattern?
  • Is the sleeplessness noticeable to others?
  • How worried they are about their sleep difficulties?
  • Does the sleeplessness impact daily functioning?

Patients whose score falls between 0 and 7 are considered to have no clinically significant insomnia; scores of 8 to 14 is considered at a subthreshold sleep condition; scores of 15-21 reflect moderate insomnia; and scores of 22-28 would be diagnosed as severe insomnia.5

In this study,4 all patients received scores of 12 or higher with a median score of 17, at the outset of the study, according to Dr. Zhou.

Dr. Zhou described the study design was a real-life protocol as "we did not screen out for anyone who was depressed or anxious." However, anyone who had a serious mental illness, such as bipolar disorder that was severe enough to impair functioning, would have been excluded from participating. Unmanaged sleep apnea was another reason for exclusion, said Dr. Zhou.

Those on sleep medicines or melatonin were permitted to participate in the study but were told to keep these doses at the same throughout the study; however, most were not taking any sleep medications at enrollment, he said.

Among the cancer types, patients had breast, thyroid, Wilms tumor, lymphoma and leukemia.

Testing the Protocol to Improve Sleep in Cancer Survivors

Step 1: The initial intervention was enrollment in a single, one-hour behavioral session. A clinical psychologist delivered concrete information that focused on facts specific to the reasons for insomnia in people treatment for cancer, as well as established sleep hygiene principles. 

The therapist would than work with the patient to identify two or three relevant strategies such as no ''screen time" for 2 hours before bed and developing a plan to carry out the recommended behavior changes over the next month.

In this study, scores were assessed after completion of Step 1, with an improvement noted: 17.1 to 11.2, P < 0.00. The authors reported that 45% of patients responded and 41% remitted.4

We considered these results to be very positive, said Dr. Zhou "The pessimists would say, 'Well, 59% weren't [cured] but the point is, if you can resolved the insomnia in 4 out of 10 patients with an hour [of training], that means you can reach many more [with the next level treatment]. And 41% is not an insignificant result."

Step 2: The researchers offered the 30 patients (59%) who did not remit in Step 1 the chance to enroll in Step 2. Of those, 14 patients who were eligible (47%) enrolled. They attended a three-session, group-based cognitive behavioral therapy (CBT) program previously tested for adult cancer survivors.

The sessions were supplemented by a workbook with further information, examples, and exercises. The material covered the etiology and maintenance of insomnia, instructions of the value and process for proper completion of sleep diaries and stimulus controls.

Based on individual sleep diary data, every participant was given a personalized sleep schedule. The final session focused on instructing participants on sleep expansion and sleep hygiene and addressed cancer late effects and maladaptive sleep cognitions, as well as long-term adherence.

After Step 2, sleep scores were reassessed and showed marked improved (16.9 to 18.8, P < 0.001), with 79% responding and 71% remitting.

Cancer Survivors Responses to a Stepped Sleep Program

"We had people who [said they] were very pleased with how basic the content was," Dr. Zhou told EndocrineWeb. Before enrolling, ''they thought the treatment [for insomnia] was going to be complicated and that they would be required to take medications."

"The basic principles of good sleep are not complicated," and were well tailored to meet the specific needs of this cohort. While not all the cancer survivors were totally cured of their sleep disturbances, his outlook is: "If we don't cure you, we will at least make you sleep better."

Participants in the study also reported improvement in mood after completing the program.4

Feasibly of Incorporating Stepped Sleep Program in Clinical Practice

Physicians should make the effort to become more aware of the sleep issues affecting their cancer patients, says Charles L. Shapiro, MD, director of translational breast cancer research and director of cancer survivorship for the Icahn School of Medicine at Mount Sinai Health System, understanding that sleep disturbances often prevail long after their treatment for cancer has been completed. He reviewed the study findings for EndocrineWeb but was not involved in the research.

"Oncologists aren't even aware of this common side effect of treatment," said Dr. Shapiro, who is a medical oncologist.

Yet, the need is there for all physicians to attend to this is very important, he said. "I think PCPs are increasingly seeing these patients and sharing the care with the oncologist. Likewise, endocrinologists are likely to be seeing many of these patients for an endocrine disorder once their cancer treatment is complete.”

He applauded the value of such as adoptable 2-step sleep program. "This is a great study," he told EndocrineWeb. The nearly 50% success rate after the one-hour session is a very good result, and, for patients in whom the one-hour was not effective, going to the three-hour Step 2 achieved ''fantastic results," he said. "Achieving a 79% response rate to the three-session [program] is equally impressive."  

"While this is a small study to be sure, still [the results] are very encouraging," he said. "Obviously, there is a need to trial the sleep program in a larger study. But this is a good start and this is important work. This is a non-drug intervention and the beauty of it is, it doesn’t require drug therapy. With insomnia, we have been constantly looking for a drug to treat the problem."

The idea of a nondrug intervention that is relatively cost effective, he said, should be very appealing to clinicians and likely will be even more appreciated by patients.

His advice: "Ask every patient the question: Are you having trouble sleeping?"

If the answer is yes, consider giving these patients referral to a therapist who specializing in cognitive behavioral therapy (CBT). Referring patients to CBT  “could be a better way to go—given the results of this small study—rather than pushing sleep drugs," Dr. Shapiro said.

Cognitive Behavioral Therapy Proves Effective in Reducing Insomnia

While the results were not perfect and not everyone was cured, if we had a patient with obesity who managed to reduce their weight loss from a body mass index of 40 kg/m2 to 33 kg/m2, we would look at that as a huge improvement, Dr. Zhou said.

The same rationale should be applied to sleep issues, he said. It is feasible to help patients improve sleep health. It might not work completely in every patient, but with effort insomnia can at least be made better in patients who have managed to get to the other side of cancer treatment, he said.

In the conclusion, the researchers said: "Our results have important implications for cancer centers and community oncology settings developing a sleep program."

Those who had sleep problems for a shorter period of time were most likely to benefit from the Step 1 session. That indicates the importance of identifying the sleep problem as early as possible, Dr. Zhou said.

Action Plan to Incorporate Sleep for Endocrinologists, Primary Care Providers

Many physicians don't touch on the subject of sleep, he said ''because they don’t know what to do." Now we have a model that is easy to implement, he said.

The low-intensity program can be done by social workers or interested physicians without specialty training. "You don't need to understand everything about sleep medicine to do the work," he told EndocrineWeb, and for the Step 2, a physician can find a provider who knows how to teach CBT for insomnia.

And, for endocrinologists dealing with patients with diabetes distress, a common issue in many patients, Dr. Zhou said his program is about improving sleep, not about specifically having cancer. So yes, he agreed the it is worth giving it a try in any patient who presents with complaints of insomnia.

One key to his education sessions, he said, is they are tailored to the individual. They did not just hand out one-size-fits-all sleep hygiene fact sheet. The program required that the specialist talk to the patients and then select methods that fit their specific needs and their lifestyles.

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