Brief Behavioral Therapy for Insomnia in Lung Cancer Survivors: A RCT

Purpose: Insomnia occurs in approximately 50 to 80% of lung cancer survivors and is associated with fatigue and daytime sleepiness, anxiety and depression, physical and cognitive functional impairment, all of which diminish quality of life and may even influence survival. Recent research has demonstrated that early integration of symptom management into treatment plans leads to meaningful improvements in quality of life, mood and survival in patients newly diagnosed with lung cancer. However, few studies have focused on insomnia.

Although cognitive behavioral therapy for insomnia (CBT-I) is a well-established and effective treatment, there remains a pressing need to study CBT-I in lung cancer survivors because they are different from other cancer patients. Smoking history, pre-existing chronic obstructive pulmonary disease, and the effects of lung cancer treatment, in particular, partial lung resection and postoperative radiotherapy can result in impaired pulmonary function resulting in hyperarousal from pain, cough and dyspnea leading to a worsening of insomnia. In addition, the appropriate dose and frequency of CBT-I in comorbid insomnia has not been determined. CBT-I consists of sleep restriction, stimulus control, relaxation, sleep hygiene education and cognitive therapy that focuses on dysfunctional sleep-related thoughts and unhelpful sleep behaviors that may exacerbate insomnia. CBT-I is the standard treatment for insomnia; however the length of treatment and the insufficient number of psychologists trained to deliver CBT-I make this unrealistic. Nurses are uniquely positioned to deliver a modified version of CBT-I, i.e., Brief Behavioral Therapy-Insomnia (BBT-I) involving sleep restriction, stimulus control, sleep hygiene education and brief telephone therapy. This study determined the efficacy of BBT-I compared to an attention control condition (healthy eating education) on the symptom of insomnia in lung cancer survivors.

Methods: Lung cancer survivors were randomized to either the experimental (BBT-I) or an attention control (healthy eating) condition. The study inclusion criteria were Insomnia Severity Index >7, pathologically confirmed stage I/II non-small cell lung cancer > 6 weeks from surgical tumor removal, able to complete data collection instruments and >21 years of age. Exclusion criteria included other untreated pre-existing sleep disorders or unstable medical or psychiatric illnesses. Participants completed a demographic and lung cancer treatment survey. Objective measures included screening for sleep apnea using the overnight ApneaLink device that utilizes oximetry, nasal airflow and an abdominal respiratory belt. Continuous non-dominant wrist movement was also recorded with actigraphy for 14-days before and after the interventions. Subjective measures before and after the interventions included Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index, Dysfunctional Beliefs & Attitudes About Sleep, Epworth Sleepiness Scale, Profile of Moods Fatigue Scale, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy-Lung and 14-day sleep diaries. The primary outcome sleep measure was ISI.

Results:  Among 44 participants who consented to participate in this study, 4 were referred for sleep apnea treatment, 40 completed baseline assessments, 2 withdrew, and 28 participants completed follow-up assessments. Demographic features at baseline included 66 years of age (+ 7.6; range 53-82), 40% (n=16) male, 87.5% (n=35) Caucasian, 50% (n=20) married, BMI 27.7 (+ 5.8), and 10% (n=4) never smokers. Disease and treatment characteristics included 80% (n=32) adenocarcinoma, 60% (n=24) stage 1A, and 90% (n=36) lobectomy. Forty participants were randomized to either the experimental intervention or the attention control, 28 completed follow up assessments. The primary outcome variable was ISI. At baseline there was no significant difference between the groups (p=.12). At follow up assessment, the mean ISI for the experimental intervention was 6.40 + 4.98, while the attention control mean was 14.10 + 4.48 (p=.001) with an effect size of 1.61. Additional new findings revealed that more than a third of the sample required referral to a pulmonologist for further evaluation: 4/44 (9%) screened positive for sleep apnea requiring referral for definitive diagnosis of sleep apnea and 12/44 (27%) had low nighttime oxygenation that required referral for supplemental oxygen.

Conclusion:  This study demonstrated efficacy of an effective, well-known intervention in the lung cancer survivorship population for the first time and will inform a larger study to evaluate implementation strategies that will promote the dissemination and sustainability of this intervention. The ultimate goal is to offer practical, evidence-based implementable interventions that improve the quality of life for cancer survivors with insomnia.