Randomized placebo-controlled trial of cognitive behavioral therapy and armodafinil for insomnia after cancer treatment

Journal of Clinical Oncology

Volumn 33, Issue 2, 2015, Pages 165-171

  Roscoe, Joseph A ^a   Garland, Sheila N ^b   Heckler, Charles E ^a   Perlis, Michael L ^b   Peoples, Anita R ^a   Shayne, Michelle ^a   Savard, Josée ^c   Daniels, Nina P ^a   Morrow, Gary R ^a  

^a UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNIVERSITÉ LAVAL   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ARMODAFINIL; PLACEBO; BENZHYDRYL DERIVATIVE; WAKEFULNESS PROMOTING AGENT;

ADULT; ARTICLE; BREAST CANCER; CANCER SURVIVOR; COGNITIVE THERAPY; CONTROLLED STUDY; DRUG INDUCED HEADACHE; FEMALE; FOLLOW UP; HUMAN; INSOMNIA; INSOMNIA SEVERITY INDEX; LIMB WEAKNESS; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; OUTCOME ASSESSMENT; PARESTHESIA; PATIENT COMPLIANCE; PITTSBURGH SLEEP QUALITY INDEX; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SKIN TINGLING; SLEEP QUALITY; BREAST NEOPLASMS; MIDDLE AGED; MULTIMODALITY CANCER THERAPY; NEOPLASMS; PROCEDURES; QUESTIONNAIRE; SEVERITY OF ILLNESS INDEX; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; TREATMENT OUTCOME;

BENZHYDRYL COMPOUNDS; BREAST NEOPLASMS; COGNITIVE THERAPY; COMBINED MODALITY THERAPY; FEMALE; FOLLOW-UP STUDIES; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; SEVERITY OF ILLNESS INDEX; SLEEP; SLEEP INITIATION AND MAINTENANCE DISORDERS; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; WAKEFULNESS-PROMOTING AGENTS;

EID: 84920884229     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.57.6769     Document Type: Article

References (34)

1. Savard J, Villa J, Ivers H, et al: Prevalence, natural course, and risk factors of insomnia comorbid with cancer over a 2-month period. J Clin Oncol 27:5233-5239, 2009.
2. Fiorentino L, Ancoli-Israel S: Insomnia and its treatment in women with breast cancer. Sleep Med Rev 10:419-429, 2006.
3. Matthews EE, Berger AM, Schmiege SJ, et al: Cognitive behavioral therapy for insomnia outcomes in women after primary breast cancer treatment: A randomized, controlled trial. Oncol Nurs Forum 41:241-253, 2014.
4. Palesh OG, Roscoe JA, Mustian KM, et al: Prevalence, demographics, and psychological associations of sleep disruption in patients with cancer: University of Rochester Cancer Center-Community Clinical Oncology Program. J Clin Oncol 28:292-298, 2010.
5. Palesh O, Peppone L, Innominato PF, et al: Prevalence, putative mechanisms, and current management of sleep problems during chemotherapy for cancer. Nat Sci Sleep 4:151-162, 2012.
6. Kotronoulas G, Wengström Y, Kearney N: A critical review of women's sleep-wake patterns in the context of neo-/adjuvant chemotherapy for earlystage breast cancer. Breast 21:128-141, 2012.
7. Savard J, Ivers H, Villa J, et al: Natural course of insomnia comorbid with cancer: An 18-month longitudinal study. J Clin Oncol 29:3580-3586, 2011.
8. Savard J, Simard S, Blanchet J, et al: Prevalence, clinical characteristics, and risk factors for insomnia in the context of breast cancer. Sleep 24:583-590, 2001.
9. Ford DE, Kamerow DB: Epidemiologic study of sleep disturbances and psychiatric disorders: An opportunity for prevention? JAMA 262:1479-1484, 1989.
10. Mellinger GD, Balter MB, Uhlenhuth EH, et al: Insomnia and its treatment: Prevalence and correlates. Arch Gen Psychiatry 42:225-232, 1985.
11. Morin CM, Bélanger L, Leblanc M, et al: The natural history of insomnia: A population-based 3-year longitudinal study. Arch Intern Med 169:447- 453, 2009.
12. Lis CG, Gupta D, Grutsch JF: The relationship between insomnia and patient satisfaction with quality of life in cancer. Support Care Cancer 16:261- 266, 2008.
13. Matteson-Rusby SE, Pigeon WR, Gehrman P, et al: Why treat insomnia? Prim Care Companion J Clin Psychiatry 12:PCC.08r00743, 2010.
14. Ozminkowski RJ, Wang S, Walsh JK: The direct and indirect costs of untreated insomnia in adults in the United States. Sleep 30:263-273, 2007.
15. Perlis ML, Jungquist C, Smith MT, et al: Cognitive Behavioral Treatment of Insomnia: A Session-by-Session Guide. New York, NY, Springer, 2005.
16. Sharma MP, Andrade C: Behavioral interventions for insomnia: Theory and practice. Indian J Psychiatry 54:359-366, 2012.
17. Matthews EE, Arnedt JT, McCarthy MS, et al: Adherence to cognitive behavioral therapy for insomnia: A systematic review. Sleep Med Rev 17: 453-464, 2013.
18. Fiorentino L, McQuaid JR, Liu L, et al: Individual cognitive behavioral therapy for insomnia in breast cancer survivors: A randomized controlled crossover pilot study. Nat Sci Sleep 2:1-8, 2010.
19. Garland SN, Carlson LE, Stephens AJ, et al: Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: A randomized, partially blinded, noninferiority trial. J Clin Oncol 32:449- 457, 2014.
20. Perlis ML, Smith MT, Orff H, et al: The effects of modafinil and cognitive behavior therapy on sleep continuity in patients with primary insomnia. Sleep 27:715-725, 2004.
21. Morin CM: Insomnia: Psychological Assessment and Management. New York, NY, Guilford Press, 1993.
22. Morin CM, Beaulieu-Bonneau S, LeBlanc M, et al: Self-help treatment for insomnia: A randomized controlled trial. Sleep 28:1319-1327, 2005.
23. Savard MH, Savard J, Simard S, et al: Empirical validation of the Insomnia Severity Index in cancer patients. Psychooncology 14:429-441, 2005.
24. Buysse DJ, Reynolds CF 3rd, Monk TH, et al: The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Res 28:193-213, 1989.
25. Mustian KM, Sprod LK, Janelsins M, et al: Multicenter, randomized controlled trial of yoga for sleep quality among cancer survivors. J Clin Oncol 31:3233-3241, 2013.
26. Little RJA, Rubin DB: Statistical Analysis with Missing Data. Hoboken, NJ, John Wiley and Sons, 2002.
27. Morin CM, Belleville G, Bélanger L, et al: The Insomnia Severity Index: Psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep 34:601-608, 2011.
28. Epstein DR, Dirksen SR: Randomized trial of a cognitive-behavioral intervention for insomnia in breast cancer survivors. Oncol Nurs Forum 34:E51- E59, 2007.
29. Espie CA, Fleming L, Cassidy J, et al: Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer. J Clin Oncol 26:4651-4658, 2008.
30. Savard J, Simard S, Ivers H, et al: Randomized study on the efficacy of cognitive-behavioral therapy for insomnia secondary to breast cancer, part II: Immunologic effects. J Clin Oncol 23:6097-6106, 2005.
31. Katz DA, McHorney CA: The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract 51:229- 235, 2002.
32. Lee KA, Ward TM: Critical components of a sleep assessment for clinical practice settings. Issues Ment Health Nurs 26:739-750, 2005.
33. Leger D, Guilleminault C, Bader G, et al: Medical and socio-professional impact of insomnia. Sleep 25:625-629, 2002.
34. Caplette-Gingras A, Savard J, Savard MH, et al: Is insomnia associated with cognitive impairments in breast cancer patients? Behav Sleep Med 11:239-257, 2013.