Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial

Purpose Insomnia is a distressing and often persisting consequence of cancer. Although cognitive behavioral therapy for insomnia (CBT-I) is the treatment of choice in the general population, the use of CBT-I in patients with cancer is complicated, because it can result in transient but substantial increases in daytime sleepiness. In this study, we evaluated whether CBT-I, in combination with the wakefulness-promoting agent armodafinil (A), results in better insomnia treatment outcomes in cancer survivors than CBT-I alone. Patients and Methods We report on a randomized trial of 96 cancer survivors (mean age, 56 years; female, 87.5%; breast cancer, 68%). The primary analyses examined whether ≥ one of the 7-week intervention conditions (ie, CBT-I, A, or both), when compared with a placebo capsule (P) group, produced significantly greater clinical gains. Insomnia was assessed by the Insomnia Severity Index and sleep quality by the Pittsburgh Sleep Quality Inventory. All patients received sleep hygiene instructions. Results Analyses controlling for baseline differences showed that both the CBT-I plus A (P = .001) and CBT-I plus P (P = .010) groups had significantly greater reductions in insomnia severity postintervention than the P group, with effect sizes of 1.31 and 1.02, respectively. Similar improvements were seen for sleep quality. Gains on both measures persisted 3 months later. CBT-I plus A was not significantly different from CBT-I plus P (P = .421), and A alone was not significantly different from P alone (P = .584). Conclusion CBT-I results in significant and durable improvements in insomnia and sleep quality. A did not significantly improve the efficacy of CBT-I or independently affect insomnia or sleep quality.

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Personalized versus standard cognitive behavioral therapy for fear of cancer recurrence, depressive symptoms or cancer-related fatigue in cancer survivors: study protocol of a randomized controlled trial (MATCH-study)

Trials ◽

10.1186/s13063-021-05657-z ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Susan J. Harnas ◽

Hans Knoop ◽

Floor Bennebroek Evertsz ◽

Sanne H. Booij ◽

Joost Dekker ◽

...

Keyword(s):

Depressive Symptoms ◽

Cognitive Behavioral Therapy ◽

Cancer Survivors ◽

Behavioral Therapy ◽

Controlled Trial ◽

Cancer Recurrence ◽

Cognitive Behavioral ◽

Fear Of Cancer Recurrence ◽

Cancer Related Fatigue ◽

Fear Of Cancer

Abstract Background Fear of cancer recurrence, depressive symptoms, and cancer-related fatigue are prevalent symptoms among cancer survivors, adversely affecting patients’ quality of life and daily functioning. Effect sizes of interventions targeting these symptoms are mostly small to medium. Personalizing treatment is assumed to improve efficacy. However, thus far the empirical support for this approach is lacking. The aim of this study is to investigate if systematically personalized cognitive behavioral therapy is more efficacious than standard cognitive behavioral therapy in cancer survivors with moderate to severe fear of cancer recurrence, depressive symptoms, and/or cancer-related fatigue. Methods The study is designed as a non-blinded, multicenter randomized controlled trial with two treatment arms (ratio 1:1): (a) systematically personalized cognitive behavioral therapy and (b) standard cognitive behavioral therapy. In the standard treatment arm, patients receive an evidence-based diagnosis-specific treatment protocol for fear of cancer recurrence, depressive symptoms, or cancer-related fatigue. In the second arm, treatment is personalized on four dimensions: (a) the allocation of treatment modules based on ecological momentary assessments, (b) treatment delivery, (c) patients’ needs regarding the symptom for which they want to receive treatment, and (d) treatment duration. In total, 190 cancer survivors who experience one or more of the targeted symptoms and ended their medical treatment with curative intent at least 6 months to a maximum of 5 years ago will be included. Primary outcome is limitations in daily functioning. Secondary outcomes are level of fear of cancer recurrence, depressive symptoms, fatigue severity, quality of life, goal attainment, therapist time, and drop-out rates. Participants are assessed at baseline (T0), and after 6 months (T1) and 12 months (T2). Discussion To our knowledge, this is the first randomized controlled trial comparing the efficacy of personalized cognitive behavioral therapy to standard cognitive behavioral therapy in cancer survivors. The study has several innovative characteristics, among which is the personalization of interventions on several dimensions. If proven effective, the results of this study provide a first step in developing an evidence-based framework for personalizing therapies in a systematic and replicable way. Trial registration The Dutch Trial Register (NTR) NL7481 (NTR7723). Registered on 24 January 2019.

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