Table 5.
Author | Sample | Measuring Instrument(s) | Measuring Time(s) & Method(s) |
Results |
---|---|---|---|---|
Barton et al., J Sup- port Oncol 2011; 9 (1) 24–31 [28] |
227 (202) Cancer patients 130 Breast 14 Colon 4 Prostate 52 Other |
PSQI; FOSQ (Functional Outcomes of Sleep Questionnaire); BFI (Brief Fatigue Inventory); POMS (Profile of Mood States); TNAS (Toxicity Numeric Analogue Scale); CTCAE (Common Terminology Criteria for Adverse Events) |
T1—Baseline T2—Follow-up (4 weeks) T3—Follow-up (8 weeks) |
|
Methods: - RCT, dopple-blind - 450 mg Valerian (Herbal Medicine versus Placebo) | ||||
Berger et al., Psycho-oncology 2009; 18 (6): 634–646 [29] | 219 Cancer patients/ stages I–III |
Actigraphy; PSQI; Sleep Diary (SOL, WASO, TIB, TST, SE) |
T1—Baseline T2—Follow-up (within 7 days) T3—Follow-up (30 days) |
|
Methods: - RCT - BT versus Controls (Behavioural Therapy [Individualized Sleep Promotion Plan (ISPP)]) | ||||
Chen et al., Breast
Cancer Res Treat 2014; 145 (2): 381–388 [30] |
95 Postmenopausal Breast CA/stages 0–III |
PSQI; CES-D (Center for Epidemiologic Studies – Depression Scale); NCCTG (North Central Cancer Treatment Group) |
T1—Baseline T2—Follow-up (4 months) |
|
Methods: - RCT, dopple-blind - 3 mg Melatonin versus Placebo | ||||
Choi et al., Integrative Cancer Therapies 2017; 16 (2) 135–146 [31] | A Systematic Review of Randomized Clinical Trials: Acupuncture for Managing Cancer-Related Insomnia | |||
Dupont et al., Health Psychol 2014; 33 (2): 155–163 [32] | 558 Mamma CA | SF-36 (partly); IES-R (Revised Impact of Event Scale); CES-D (Center for Epidemiologic Studies—Depression Scale); PANAS (Positive and Negative Affect Scale) FSI (Fatigue Symptom Inventory); MOS (Medical Outcomes Study); BCPT (Breast Cancer Prevention Trial) |
T1—Baseline T2—Post-Treatment (4 weeks) T3—Follow-up (2 months) T4—Follow-up (6 months) T5—Follow-up (12 months) |
|
Methods: three types of information: (1) print material (2) print material & peer- modeling videotape (3) print material, videotape, 2 education sessions & information workbook | ||||
Epstein & Dirksen, Oncology Nursing
Forum 2007; 34 (5); 51–59 [33] |
81 Mamma CA - 40 Controls - 41 CBT-I |
Actigraphy; Sleep Diary (SOL, WASO, TIB, TST, SE) PFS (Piper Fatigue Scale) |
T1—Baseline T2—Post-CBT-I (6 weeks) T3—Follow-up (12 weeks) |
|
Methods:
| ||||
Espie et al., J of
Clinical Oncology 2008; 26: 4651–4658 [34] |
150 CA 87 Mamma 34 Prostate 24 Colorectal 5 Gynecological (110 CBT/50 TAU) |
PSQI; ESS; Sleep Diary (SOL, WASO, TST, SE); HADS; FSI (Fatigue Symptom Inventory); CrQoL (Cancer-Related Quality of Life); FACT-G (Functional Assessment of Cancer Therapy Scale – General) |
T1—Baseline T2—Post-Treatment T3—Follow-up (6 months) |
|
Methods:
| ||||
Fiorentino et al., Nature and Science of Sleep 2010; 2: 1–8 [35] |
21 Mamma CA - 11 IND-CBT-I - 10 Controls |
Actigraphy; PSQI; Insomnia Severity Index (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) |
T1—Baseline T2—Post-CBT-I (6 weeks) T3—Follow-up (12 weeks) |
|
Methods:
| ||||
Fleming (Espie) et al., Psychooncology 2014; 23 (6): 679–684 [36] |
113 Cancer patients with Insomnia - 73 CBT-I - 40 Controls |
PSQI; Sleep Diary (SOL, WASO, TIB, TST, SE) HADS; FSI (Fatigue Symptom Inventory) |
T1—Baseline T2—Post-Treatment T3—Follow-up (6 months) |
|
Methods:
| ||||
Garland et al., Contemporary Clinical Trials 2011; 32 (5): 747–754 [37] |
??? | Actigraphy; Sleep Diary (SOL, WASO, TST, SE) ??? |
T1—Baseline T2—Post-Treatment (2 months) T3—Follow-up (3 months) |
|
Methods: CBT-I versus MBSR (Mindfulness-Based Stress Reduction) | ||||
Garland et al., J
Clin Oncol 2014; 32: 1–9 [38] |
327 screened CA 111 randomly assigned 53 Breast 12 Prostate 11 Blood/lymph 10 Female Genitourinary 9 Head & Neck 7 Colon/GI 7 Lung 2 Skin CBT-I: n = 47 MBSR: n = 64 |
Actigraphy; PSQI; Insomnia Severity Index (ISI); Sleep Diary (SOL, WASO, TST, SE) |
T1—Baseline T2—Post-Treatment (2 months) T3—Follow-up (5 months) |
|
Methods: CBT-I versus MBSR (Mindfulness-Based Stress Reduction) | ||||
Garland et al., Neuropsychiatric Disease and Treatment 2014; 10: 1113–1124 [39] |
Review: Efficency of CBT-I in cancer Inclusion of 4 studies |
|
→ clinically improvements in subjective sleep outcomes improved sleep → Improvement in:
|
|
Garland et al., Explore (N.Y.) 2015; 11 (6): 445–454 [40] | 72 Cancer patients MBCR: n = 32 CBT-I: n = 40 |
??? | T1—Baseline T2—Post-Treatment (? months) T3—Follow-up (3 months) |
|
Methods: CBT-I versus MBCR (Mindfulness-Based Cancer Recovery) | ||||
Garland et al., Contemporary Clinical Trials 2016; 47: 349- 355 [41] |
160 Cancer patients with Insomnia |
??? | T1—Baseline T2—Mid-Treatment (4 weeks) T3—Post-Treatment (8 weeks) T4—Follow-up (3 months) |
??? |
Methods:
| ||||
Garland et al., Sleep Medicine 2016; 20: 18–24 [42] | 88 Cancer patients with Insomnia |
ESS; Sleep Diary (SOL, WASO, TST, SE) |
T1—Baseline T2—Post-Treatment (7 weeks) T3—Follow-up (3 months) |
|
Methods: (RCT) (1) CBT-I + P (CBT-I and Placebo) (2) CBT-I + A (CBT-I and Armodafinil) (3) ARM (Armodafinil alone) (4) PLA (Placebo alone) | ||||
Heckler (Garland) et al., Supportive Care in Cancer 2016; 24 (5): 2059–2066 [44] | 96 Cancer patients with Insomnia |
Insomnia Severity Index (ISI); BFI (Brief Fatigue Inventory); FACIT-Fatigue scale |
T1—Baseline T2—Post-Treatment (7 weeks) T3—Follow-up (3 months) |
|
Methods: (RCT) (1) CBT-I + P (CBT-I and Placebo) (2) CBT-I + A (CBT-I and Armodafinil) (3) ARM (Armodafinil alone) (4) PLA (Placebo alone) | ||||
Irwin et al., JNCIM 2014; No. 50; 295–301 [46] |
90 Mamma CA random subsample (n = 48) |
Blood samples: - C-Reactive Protein (CRP) - Interleukin-6 (IL-6) - Tumor Necrosis Factor-α (TNF) subsample analyzed by genome-wide transcriptional profiling |
T1—Baseline T2—Post-Treatment (3 months) |
|
Methods: CBT-I versus TCC (Tai Chi Chih) | ||||
Kim M. et al., BMJ open, 2017; 7 (8): 1- 10 [47] |
45 Cancer patients |
Actigraphy; Insomnia Severity Inventory (ISI); PSQI; Sleep Diary (SOL, WASO, TIB, TST, SE) BDSS (Blood Deficiency Scoring System); EA (Electroacupuncture); FACT-F (Functional Assessment of Cancer Therapy- Fatigue); MoCA (Montreal Cognitive Assessment) |
T1—Baseline T2—Treatment (3 weeks) T2—Post-Treatment (5 weeks) T2—Post-Treatment (9 weeks) |
Without results !!!
„The result of this study will be published in peer-reviewed journals or presented at academic conferences.“ |
Methods: (4 weeks) EA versus Sham-EA (Electroaccupuncture) versus TAU (Treatment As Usual) | ||||
Kim S.W. et al., Psychiatry and Clinical Neurosciences 2008; 62: 75–83 [48] |
45 Cancer patients 25 Lung 5 Breast 6 Gastrointestinal tract 3 Hepatobiliary tract 3 Other malignancy |
C-LSEQ (Chonnam National University Hospital- Leeds Sleep Evaluation Questionnaire) SF-36; MADRS (Montgomery-Asberg Depression Rating Scale); EuroQoL (EQ) -5D |
T1—Baseline T2—Post-Treatment (4 weeks) |
mirtazapine rapidly improved sleep disturbance, nausea, pain and quality of life, as well as depression in cancer patients Sleep ↑: ↑ TST, ↓ SOL, ↓ SQ |
Methods:
| ||||
Kröz et al., BMC
cancer 2017; 17 (1), 166: 1–13 [49] |
126 Mamma CA | PSQI; CFS-D (Cancer Fatigue Scale) |
T1—Baseline T2—Post-Treatment (10 weeks) T3—Follow-up (6 months) |
|
Methods: (RCT) (a) MT (Multimodal Treatment) (b) CT (MT + AeT) (Combined Treatment) (c) AeT (Aerobic Training) | ||||
Lengacher et al., Psychooncology 24 (4): 424–432 [50] |
79 Mamma CA /stages 0-III |
OSP (Objective Sleep Parameters): - Actigraphy SSP (Subjective Sleep Parameters): - PSQI; - Sleep diary |
T1—Baseline T2—Treatment (6 weeks) T2—Post-Treatment (12 weeks) |
|
Methods: (RCT) MBSR (BC) vs. UC (Mindfulness-Based Stress Reduction [Breast Cancer]) (Usual Care) | ||||
Marshall-McKenna et al., Supportive Care in Cancer 2016; 24 (4): 1821–1829 [51] | 74 Mamma CA with Insomnia - 68.9 % pre-menopausal - 31.1% post-menopausal |
HADS; FACT-B (Functional Assessment of Cancer Therapy - Breast) sleep/hot flush diaries (over 2-week periods) |
T1—Baseline T2—Treatment (x weeks) T3—Post-Treatment (x weeks) |
|
Methods: (RCT) - Intervention Arm: CPPT + SC (Cool Pad Pillow Topper + Standard Care) vs. - Control Arm: SC (Standard Care) | ||||
Mendoza et al., Psychooncology 2017; 26 (11): 1832–1838 [52] | 44 Cancer patients | MOOS (Medical Outcomes Survey Sleep); PROMIS (Fatigue) (Problem Index Patient-reported Outcomes Measurement Information System); NRS (Pain intensity) (Numerical Rating Scales) |
T1—Baseline T2—Treatment (3 weeks) T3—Post-Treatment (3 months) |
VMWH-CBT vs. Controls → beneficial effects of the VMWH-CBT - sleep problems - fatigue - average pain intensity |
Methods: - RCT, cross-over - VMWH-CBT vs. Controls (Valencia model of Waking Hypnosis with Cognitive-Behavioural Therapy) | ||||
Peoples (Garland) et al., Journal of Cancer Survivorship 2017; 11 (3): 401–409 [55] |
95 Cancer patients with Insomnia |
Insomnia Severity Index (ISI); FACT-G (QoL) (Functional Assessment of Cancer Therapy - General) |
T1—Baseline T2—Post-Treatment (7 weeks) T3—Follow-up (3 months) |
|
Methods: (RCT) (1) CBT-I + P (CBT-I and Placebo) (2) CBT-I + A (CBT-I and Armodafinil) (3) ARM (Armodafinil alone) (4) PLA (Placebo alone) | ||||
Ritterband et al., Psychooncology 2012; 21 (7): 695–705 [56] | 28 Cancer patients with Insomnia |
Insomnia Severity Index (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) MFSI-SF (Multidimensional Fatigue Symptom Inventory - Short Form); UQ (Internet Intervention Utility Questionnaire); HADS; SF-12 |
T1—Baseline T2—Post-Treatment (3 months) |
SHUTi vs. Controls → beneficial effects of the SHUTi - ↓ ISI - ↓ HADS - ↑ SF-12 - Sleep Diary: ↑ SE, ↑ TST, ↓ SOL & ↓ WASO (Controls improved a little too: SE & WASO) |
Methods:
| ||||
Roscoe, J.A., (Garland, Sh.N.) et al., Journal of Clinical Oncology 2015; 33 (2): 165–171 [57] | 96 Cancer patients with Insomnia |
PSQI; Insomnia Severity Index (ISI) | T1—Baseline T2—Post-Treatment (7 weeks) T3—Follow-up (3 months) |
CBT-I + A & CBT-I + P: → CBT-I improves Insomnia Severity (ISI) → CBT-I improves Sleep Quality (PSQI) → Armodafinil no effect on Insomnia & SQ |
Methods: (RCT) (1) CBT-I + P (CBT-I and Placebo) (2) CBT-I + A (CBT-I and Armodafinil) (3) ARM (Armodafinil alone) (4) PLA (Placebo alone) | ||||
Savard (Quesnel) et al., JCCP 2003; 71 (1): 189–200 [59] | 10 Mamma CA | PSG; Insomnia Severity Inventory (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) MFI (Multidimensional Fatigue Inventory); BDI & STAI; QLQ-C30+ 3 (European Organization for Research & Treatment of Ca. Quality of Life Questionnaire) |
T1—Baseline T2—Post-Treatment (3 months) T3—Follow-up (6 months) |
CBT was associated with - ↓ ISI: = ↓ Insomnia severity - ↑ PSG & ↑ Sleep Diary: = ↑ SE, ↑ TST, ↓ SOL & ↓ WASO |
Savard et al., Journal
of Pain and Symptom Management 2004; 27 (6): 513–522 [60] |
24 Mamma CA | PSG; Skin conductance |
??? |
|
Methods: CBT | ||||
Savard et al., JCO
2005 I & II; 23 (25): 6083–6096 & 6097- 6106 [61] |
57 women with insomnia caused or aggravated by breast cancer |
PSG; Insomnia Severity Inventory (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) MFI (Multidimensional Fatigue Inventory); HADS; QLQ-C30+ 3 (European Organization for Research & Treatment of Ca. Quality of Life Questionnaire); Immune measures: enumeration of blood cell counts (i.e., WBCs, monocytes, lymphocytes, CD3, CD4, CD8, CD16/CD56) & cytokine product. (Interleukin-1-beta [IL-1β], Interferon gamma [IFN-γ]) |
T0—Pre-Waiting T1—Baseline T2—Post-Treatment T3—Follow-up (3 months) T4—Follow-up (6 months) T5—Follow-up (12 months) |
CBT was associated with (post-treatment vs. control patients) - ↓ ISI: = ↓ Insomnia severity - ↑ PSG & ↑ Sleep Diary: = ↑ SE, ↑ TST, ↓ SOL & ↓ WASO - higher secretion and/or level of IFN-γ & IL-1β - lower increase of lymphocytes |
Methods: CBT versus WLC (Waiting-List Control) | ||||
Savard (Tremblay) et al., JCCP 2009; 77 (4): 742–750 [62] | 57 Mamma CA | PSG; Insomnia Severity Inventory (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) DBAS (Dysfunctional Beliefs and Attitudes about Sleep Scale); ABS (Adherence to Behavioural Strategies) TEPCQ (Treatment Expectancies and Perceived Credibility Questionnaire); TAPQ (Therapeutic Alliance Perception Questionnaire); HADS |
T1—Baseline T2—Post-Treatment (2 months) T3—Follow-up (6 months) |
|
Methods: CBT versus WLC (Waiting-List Control) | ||||
Savard et al., Psycho-Oncology 2013; 22 (6): 1381–1388 [65] | 60 Prostate CA | Insomnia Severity Index (ISI); PSQ (Physical Symptoms Questionnaire) |
T1—Baseline Tx—1, 2, 4, 6, 8 & 12 months T8—16 months |
|
Methods: ADT (Androgen Deprivation Therapy) RTH (Radiation therapy) | ||||
Savard (Casault) et al., Behaviour Research and Therapy 2013; 67: 45–54 [66] |
83 Cancer patients |
??? | T1—Baseline T2—Post-Treatment T3—Follow-up (3 months) T4—Follow-up (6 months) |
|
Methods: mCBT versus no Treatment (minimal CBT) | ||||
Savard et al., Sleep 2014; 37 (8): 1305- 1314 [68] |
242 Mamma CA | Actigraphy; Insomnia Severity Index (ISI); Sleep Diary (SOL, WASO, TIB, TST, SE) |
T1—Baseline T2—Post-Treatment (6 weeks) |
- ↓ Insomnia severity - ↓ Early Morning Awakenings (EMA) - ↓ depression - ↓ fatigue - ↓ dysfunctional beliefs about sleep
- 71.3% vs. 44.3%, p < 0.005 |
Methods: (RCT) (1) Professionally administered CBT-I (PCBT-I; n = 81) (2) Video-based CBT-I (VCBT-I; n = 80) (3) no treatment (CTL; n = 81) | ||||
Savard et al., Sleep 2016; 39 (4): 813–823 [69] |
242 Mamma CA | Insomnia Severity Index (ISI); Insomnia Interview Schedule (IIS); Sleep Diary (SOL, WASO, TIB, TST, SE) MFI (Multidimensional Fatigue Inventory) EORTC QLQ-C30; HADS; DBAS-16 (Dysfunctional Beliefs & Attitudes about Sleep Scale – Abbreviated version); |
T1—Baseline T2—Post-Treatment (6 weeks) T3—Follow-up (3 months) T4—Follow-up (6 months) T5—Follow-up (12 months) |
- ↓ Insomnia severity (ISI, IIS) - ↓ Early Morning Awakenings (EMA) - ↓ depression - ↓ anxiety - ↓ dysfunctional beliefs about sleep - ↑ QoL
VCBT-I and CTL: e.g., 12 month FU - 67% vs. 59% vs. 48%, p < 0.100 |
Methods: (RCT) (1) Professionally administered CBT-I (PCBT-I; n = 81) (2) Video-based CBT-I (VCBT-I; n = 80) (3) no treatment (CTL; n = 81) | ||||
Simeit et al., Suppor-tive Care in Cancer 2004; 12 (3): 176–183 [70] |
229 Cancer patients (breast, kidney or prostate) |
??? | T1—Baseline T2—Post-Treatment (3-4 weeks) T3—Follow-up (6 months) |
- sleep latency (p < 0.001) - sleep duration (p < 0.001) - sleep efficiency (p < 0.001) - sleep quality (p < 0.001) - sleep medication (p < 0.050) - daytime dysfunction (p < 0.050) - quality-of-life
|
Methods: (RCT) (1) Progressive Muscle Relaxation (PMR; n = 80) (2) Autogenic Training (AT; n = 71) (3) Control Group (CG; n = 78) | ||||
Zhou et al., Behavioral Sleep Medicine 2017; 15 (4): 288–301 [71] |
10 (12) Cancer patients | Insomnia Severity Index (ISI); PSQI; Sleep logs [SL]; (SOL, WASO, TIB, TST, SE); SF-12 |
T1—Baseline T2—Post-Treatment (20 days) T3—Follow-up (2 months after T2) |
↑ SE, ↓ SOL, ↓ WASO & ↓ EMA - ↓ Insomnia severity (ISI) - ↓ Sleep Quality (PSQI)
- QoL |
Methods: - Adapted CBT-I 3 x intervention in person (6) and via videoconference (6) |
Notes: ???: unclear; ↑: increase; ↓: decrease.