TY - JOUR
T1 - A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances
T2 - NCCTG N07C4 (Alliance)
AU - Barton, Debra L.
AU - Atherton, Pamela J.
AU - Satele, Daniel V.
AU - Qin, Rui
AU - Dakhil, Shaker
AU - Pipe, Teri
AU - Hobday, Timothy
AU - Fee-Schroeder, Kelli
AU - Loprinzi, Charles L.
N1 - Funding Information:
The following institutional networks participated in this study: AdventHealth Orlando, Orlando, FL, Carlos Alemany; Altru Cancer Center, Grand Forks, ND, Grant Seeger; Cancer Research for the Ozarks NCORP, Springfield, MO, Jay Carlson, UG1CA189822; Coborn Cancer Center at Saint Cloud Hospital, Saint Cloud, MN, Donald Jurgens; Georgia Cares Minority Underserved NCORP, Augusta, GA, Sharad Ghamande, UG1CA189851; Heartland Cancer Research NCORP, Decatur, IL, Bryan Faller, UG1CA189830; Iowa-Wide Oncology Research Coalition NCORP, Des Moines, IA, Robert Behrens, UG1CA189816; Loyola University Medical Center, Maywood, IL, Scott Smith; Mayo Clinic LAPS, Rochester, MN , Steven Alberts, U10CA180790; Michigan Cancer Research Consortium NCORP, Ann Arbor, MI, Philip Stella, UG1CA189971; NCORP of the Carolinas (Greenville Health System NCORP), Greenville, SC, Jeffrey Giguere, UG1CA189972; Northern Indiana Cancer Research Consortium, South Bend, IN; Ochsner NCI Community Oncology Research Program, New Orleans, LA, John Cole, UG1CA189870; Roswell Park Comprehensive Cancer LAPS, Buffalo, NY, Ellis Levine, U10CA180866; Sanford NCI Community Oncology Research Program of the North Central Plains, Sioux Falls, SD, Preston Steen, UG1CA189825; Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, NC, James Atkins, UG1CA189858; University of Chicago Comprehensive Cancer Center LAPS, Chicago, IL; Hedy Kindler , U10CA180836; WellSpan Health-York Cancer Center, York, PA, Dennis Johnson; and Wichita NCI Community Oncology Research Program, Wichita, KS, Shaker Dakhil, UG1CA189808.
Funding Information:
Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under the Award Number UG1CA189823 (Alliance for Clinical Trials in Oncology NCORP Grant) (Jan C. Buckner, MD, contact PI), U10CA180790, and UG1CA189808. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health. Acknowledgements
Publisher Copyright:
© 2020, Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2020/12
Y1 - 2020/12
N2 - Purpose: Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I). Methods: This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint. Results: Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms. Conclusions: Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed. Clinical relevance: This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size. Trial registration: ClinicalTrials.gov
AB - Purpose: Sleep disturbance is a prevalent problem for cancer survivors and effective behavioral treatments are not widely used for this population. This study evaluated home-based sleep interventions based on cognitive behavioral therapy for insomnia (CBT-I). Methods: This phase II randomized controlled trial evaluated two manualized interventions over 7 weeks. The intervention group received sleep hygiene information, stimulus control, sleep restriction, and a bedtime imagery audio recording. The control group was similar, but without sleep restriction and used audio recordings of bedtime short stories instead of imagery. Eligibility included adult cancer survivors who had trouble falling asleep or falling back to sleep on 3 of 7 days. Patients with diagnoses of sleep or mental health disorders were excluded. The primary endpoint was change in time to fall asleep or falling back to sleep after awakening, from baseline to week 7. Two-sample T tests evaluated differences between arms for this endpoint. Results: Ninety-three of 168 planned participants were enrolled from 20 institutions. The study closed early for poor accrual. Baseline time to sleep was 45 min and 52 min for the intervention and control group, respectively. At 7 weeks, both groups improved, the intervention group to 26 min and control group to 30 min, a non-significant difference between groups (p = 0.85). Secondary outcomes improved in both groups with no significant differences between arms. Conclusions: Improvement in sleep outcomes in both arms was consistent with other CBT-I interventions delivered through alternative approaches to provider-delivered therapy. More research on optimal scalable delivery of CBT-I is needed. Clinical relevance: This study supports the effectiveness of CBT-I based behavioral interventions for sleep but also the need for better delivery methods to improve uptake and effect size. Trial registration: ClinicalTrials.gov
KW - Behavioral intervention
KW - CBT-I
KW - Cancer survivors
KW - Sleep disturbance
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U2 - 10.1007/s00520-020-05461-6
DO - 10.1007/s00520-020-05461-6
M3 - Article
C2 - 32307658
AN - SCOPUS:85084073138
SN - 0941-4355
VL - 28
SP - 6085
EP - 6094
JO - Supportive Care in Cancer
JF - Supportive Care in Cancer
IS - 12
ER -