Peoples, A.R., Garland, S.N., Perlis, M.L., Savard, J., Heckler, C.E., Kamen, C.S., . . . Roscoe, J.A. (2017). Effects of cognitive behavioral therapy for insomnia and armodafinil on quality of life in cancer survivors: A randomized placebo-controlled trial. Journal of Cancer Survivorship, 11, 401–409.

The purpose was to study the effects of cognitive behavioral therapy on quality of life (QOL) among patients post-cancer treatment through a reduction in insomnia.

Four participant groups were created: those receiving CBT-I + placebo, CBT-I + armodafinil, armodafinil, and a placebo. CBT-I interventions took place over 7 weeks, where participants met one-on-one with a trained therapist and followed a treatment manual. Sessions were conducted once a week, with the first, second, and fourth held in person, and lasted 30-60 minutes; the third, fifth, sixth, and seventh were held over the telephone over 15-30 minutes. For groups taking armodafinil, 50 mg was taken in the morning and afternoon for 47 days. QOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G) instrument, while insomnia severity was measured with the Insomnia Severity Index (ISI). These surveys were completed by participants before receiving the intervention, during the intervention, postintervention, and 3 months following the intervention completion.

• N: 95   
• AGE: Range = 26-75 years, Mean = 56.2 years
• MALES: 11.6%  
• FEMALES: 88.4%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Cancer survivors of any type who had completed chemotherapy and/or radiation therapy at least one month or longer prior to the study start, with an inclusion criteria of baseline clinically diagnosed chronic insomnia.

• SITE: Multisite   
• SETTING TYPE: Multiple settings    
• LOCATION: Two northeastern U.S. cities

PHASE OF CARE: Late effects and survivorship

Four groups were established in an RCT. Participants were blinded to medication but not CBT-I. Control groups received a placebo.

QOL was measured using the Functional Assessment of Cancer Therapy General (FACT-G), an instrument measuring physical, functional, social, and emotional well-being and scored from 0-108, with higher scores indicating better QOL. Insomnia severity was measured using the Insomnia Severity Index, ranging from 0-28, with higher scores indicating worse insomnia.

Both CBT-I groups reported improvement of significance in QOL scores with mean increase of 9.5 on the FACT-G scale (p < 0.0001) compared to the groups without CBT-I. There was no statistical difference in QOL reports between the CBT-I + placebo and CBT-I + armodafinil groups. However, correlational and path analysis indicated that these improvements on QOL were associated with improvements in insomnia and that CBT-I did not demonstrate a direct effect of significance on QOL scores but rather, a significant effect on insomnia severity (p < 0.0001) that demonstrated a significant improvement in QOL scores (p < 0.0001) From baseline, changes in QOL from pre- to postintervention for CBT-I+ placebo, CBT-I + armodafinil, armodafinil, and placebo were 9.6, 11.6, -0.2, and 3.3. Follow-up QOL for CBT-I + placebo, CBT-I + armodafinil, armodafinil, and placebo was 91.4, 93.8, 78.7, and 78.6, respectively, which did not demonstrate significance from postintervention.

CBT-I demonstrated a significant effect in the reduction of insomnia among cancer survivors, which resulted in an indirect improvement in patient QOL. However, generalizability and broad feasibility may be limited because of cultural and socioeconomic variances, as well as resource availability.

• Small sample (< 100)
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%

Patient sleep quality and associated effect on QOL are important considerations for nursing. Regardless of intervention, this study demonstrates meaningful improvement of QOL can occur when sleep quality is improved. Nurses are in a relevant position to assess and advocate for interventions for sleep disturbance.