Home-Based Programs for Improving Sleep in Cancer Survivors

• Sponsor: Alliance for Clinical Trials in Oncology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00993928
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 93
• Locations: 193
• Arms: 2
• Actual Duration (Months): 109
• Patients Per Site: 0.5
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors.

PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivor; Fatigue; Psychosocial Effects of Cancer and Its Treatment; Sleep Disorders	Behavioral: Home-based sleep intervention	Phase 2

Detailed Description

OBJECTIVES:

Primary

• To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances,as measured by sleep latency or time to fall back asleep after initial sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer survivors.

Secondary

• To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline (week 1) and weeks 4 and 7 in these participants.

• To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the percentage of participants in each group who show improved sleep per the Pittsburgh Sleep Quality Index.

• To compare the effects of these interventions on fatigue, mood disturbance, sleep, benefit, and distress in this patient population.

• To describe the side effects associated with these interventions in these patients.

• To describe patient practice habits and adherence measured via a sleep behavior record.

• To explore symptom clusters in this patient population and look at distress as a mediating variable. (Exploratory)

• To explore predictors of sleep quality. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to current (≥ 1 per week in the past 4 weeks) pharmacological treatment, including anxiolytics, for insomnia or mood (yes vs no), current pharmacologic treatment for pain (yes vs no), sleep difficulty period (≤ 1 month vs > 1 month), and age (≤ 50 vs 51-70 vs > 70 years). Patients are randomized to 1 of 2 intervention groups.

• Group 1: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, instructions on sleeping restrictions, and a guided-imagery pre-recorded mp3 device. Participants meet with study personnel for intervention refinement and are asked to practice behaviors consistent with the stimulus-control sheet, to read the sleep hygiene booklet one chapter per day for 7 days during the first week, and then as needed during study. They are also instructed to use the CD, with or without headphones, in a quiet and comfortable place without lights for up to 30 minutes every day for 6 weeks before bedtime. Participants are instructed to go to sleep and wake at the same time every day during study intervention.

• Group 2: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, and a pre-recorded mp3 device containing short stories and essays. Participants meet with study personnel and are instructed to practice behaviors consistent with the stimulus control sheet, to read the sleep hygiene booklet, and use the CD as in group 1. Participants are not instructed about sleeping restrictions. They are offered the guided-imagery CD after study completion.

Patients complete a Three-Day Sleep Behavior Record for 3 consecutive days at baseline and during weeks 4 and 7 of study intervention. Patients also complete questionnaires on Numeric Analog Sleep for Pain Scale, daily use of CD, Sleep Hygiene Practice, Pittsburgh Sleep Quality Index, Profile of Mood States, Brief Fatigue Inventory, Distress Thermometer, Side-Effect Questionnaire, and a Subject Global Impression of Change at baseline, during weeks 2 and 6, and after completion of study intervention.

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances
• Actual Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: Home-based sleep intervention with Device #1 Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.	Behavioral: Home-based sleep intervention; Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Active Comparator: Arm B: Home-based sleep intervention with Device #2 Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.	Behavioral: Home-based sleep intervention; Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.

Outcome Measures

Primary Outcome Measures

1. Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7 [Baseline and 7 weeks]

   The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" > > Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.

Secondary Outcome Measures

1. Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7. [Baseline and 7 weeks]

   Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:> How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)> How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)> How many times did you awaken last night?> How long did it take you to get to sleep last night?> > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test.

2. Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI) [Baseline and 7 weeks]

   The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.

3. Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) [At baseline and week 7]

   The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as "tense", "angry", "worn out", etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.

4. Distress at Week 6 [From baseline to week 7]

   The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Prior diagnosis of cancer

• At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy)

• Ongoing hormonal therapy (i.e., tamoxifen, aromatase inhibitors, casodex)

• Concurrent trastuzumab and maintenance rituximab allowed

• Sleep difficulty defined as self report of sleep latency of ≥ 30 minutes on 3 out of 7 nights in a week and wishing therapeutic intervention, and/or self report of waking up after first falling asleep and not being able to fall back asleep for ≥ 30 minutes on 3 out of 7 nights in a week

• No history of diagnosis of primary insomnia (patient medical record, defined by having had behavioral, cognitive, or pharmacologic treatment) for > 30 consecutive days in the year before cancer diagnosis

• No active cancer (i.e., not considered no evidence of disease)

• No concurrent CNS malignancy

• No history of diagnosed sleep disorder (i.e., obstructive sleep apnea, restless legs, or periodic leg movement disorder)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• Availability of a CD player and head or earphones

• Ability to complete questionnaires

• No uncontrolled chronic pain (i.e., pain score of ≥ 4 on Numeric Analogue Sleep and Pain Scale)

• No diagnosis of major depression disorder, acute anxiety disorder, or schizophrenia per medical record

• No hot flashes that interrupt sleep

• Not working overnight hours and unable to change schedule

• No emotional, psychological, or physical state that, according to physician and/or study personnel evaluation, would preclude adherence to daily home intervention implementation

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• More than 4 days since prior corticosteroid, including inhaled steroids, of any dose for > 2 days

• No prior experience with guided imagery or cognitive behavioral therapy for insomnia

• No concurrent new herbal therapies

• Stable dose of daily herbal supplements started ≥ 8 weeks before study intervention allowed

• Herbal teas or herbs in various drink products allowed

• No concurrent treatment with variable doses of any of the following:

• Antidepressants

• Anxiolytics

• Pain medication (not including over the counter ad anti-inflammatory pain relievers)

• Pharmacologic treatment for sleep/wake disturbances is allowed, but must be used for 4 weeks before study entry, and can be used daily or intermittently

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259-5499
2	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center	Hartford	Connecticut	United States	06105
3	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida	United States	33805
4	Florida Hospital - Orlando	Orlando	Florida	United States	32803
5	Phoebe Putney Memorial Hospital	Albany	Georgia	United States	31701
6	Oncare Hawaii, Incorporated - Pali Momi	'Aiea	Hawaii	United States	96701
7	Pali Momi Medical Center	'Aiea	Hawaii	United States	96701
8	Oncare Hawaii Inc-POB II	Honolulu	Hawaii	United States	96813
9	Queen's Medical Center	Honolulu	Hawaii	United States	96813
10	Straub Clinic and Hospital, Incorporated	Honolulu	Hawaii	United States	96813
11	University of Hawaii	Honolulu	Hawaii	United States	96813
12	OnCare Hawaii, Incorporated - Kuakini	Honolulu	Hawaii	United States	96817-3169
13	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96826
14	Castle Medical Center	Kailua	Hawaii	United States	96734
15	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii	United States	96766
16	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
17	Saint Alphonsus Regional Medical Center	Boise	Idaho	United States	83706
18	Weiss Memorial Hospital	Chicago	Illinois	United States	60640
19	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana	United States	46107
20	Elkhart Clinic, LLC	Elkhart	Indiana	United States	46514-2098
21	Michiana Hematology-Oncology, PC - Elkhart	Elkhart	Indiana	United States	46514
22	Elkhart General Hospital	Elkhart	Indiana	United States	46515
23	Community Howard Regional Health	Kokomo	Indiana	United States	46904
24	Howard Community Hospital	Kokomo	Indiana	United States	46904
25	Center for Cancer Therapy at LaPorte Hospital and Health Services	La Porte	Indiana	United States	46350
26	Michiana Hematology-Oncology, PC - South Bend	Mishawaka	Indiana	United States	46545-1470
27	Saint Joseph Regional Medical Center	Mishawaka	Indiana	United States	46545-1470
28	Michiana Hematology Oncology PC - Plymouth	Plymouth	Indiana	United States	46563
29	Reid Hospital & Health Care Services	Richmond	Indiana	United States	47374
30	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
31	Memorial Hospital of South Bend	South Bend	Indiana	United States	46601
32	Michiana Hematology Oncology PC-South Bend	South Bend	Indiana	United States	46601
33	Michiana Hematology Oncology PC - La Porte	Westville	Indiana	United States	46391
34	Cedar Rapids Oncology Associates	Cedar Rapids	Iowa	United States	52403
35	Mercy Hospital	Cedar Rapids	Iowa	United States	52403
36	Mercy Regional Cancer Center at Mercy Medical Center	Cedar Rapids	Iowa	United States	52403
37	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
38	Mercy Cancer Center at Mercy Medical Center - North Iowa	Mason City	Iowa	United States	50401
39	Siouxland Hematology-Oncology Associates, LLP	Sioux City	Iowa	United States	51101
40	Mercy Medical Center - Sioux City	Sioux City	Iowa	United States	51102
41	St. Luke's Regional Medical Center	Sioux City	Iowa	United States	51104
42	Cancer Center of Kansas, PA - Chanute	Chanute	Kansas	United States	66720
43	Cancer Center of Kansas, PA - Dodge City	Dodge City	Kansas	United States	67801
44	Cancer Center of Kansas, PA - El Dorado	El Dorado	Kansas	United States	67042
45	Cancer Center of Kansas - Fort Scott	Fort Scott	Kansas	United States	66701
46	Cancer Center of Kansas-Independence	Independence	Kansas	United States	67301
47	Cancer Center of Kansas, PA - Kingman	Kingman	Kansas	United States	67068
48	Lawrence Memorial Hospital	Lawrence	Kansas	United States	66044
49	Cancer Center of Kansas, PA - Liberal	Liberal	Kansas	United States	67901
50	Cancer Center of Kansas-Liberal	Liberal	Kansas	United States	67901
51	Cancer Center of Kansas, PA - Newton	Newton	Kansas	United States	67114
52	Cancer Center of Kansas, PA - Parsons	Parsons	Kansas	United States	67357
53	Cancer Center of Kansas, PA - Pratt	Pratt	Kansas	United States	67124
54	Cancer Center of Kansas, PA - Salina	Salina	Kansas	United States	67401
55	Cancer Center of Kansas, PA - Wellington	Wellington	Kansas	United States	67152
56	Associates in Womens Health, PA - North Review	Wichita	Kansas	United States	67208
57	Cancer Center of Kansas, PA - Medical Arts Tower	Wichita	Kansas	United States	67208
58	Cancer Center of Kansas, PA - Wichita	Wichita	Kansas	United States	67214
59	CCOP - Wichita	Wichita	Kansas	United States	67214
60	Via Christi Cancer Center at Via Christi Regional Medical Center	Wichita	Kansas	United States	67214
61	Cancer Center of Kansas, PA - Winfield	Winfield	Kansas	United States	67156
62	Ochsner Clinic Foundation-Baton Rouge	Baton Rouge	Louisiana	United States	70809
63	Ochsner Baptist Medical Center	New Orleans	Louisiana	United States	70115
64	Ochsner Cancer Institute at Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
65	Bixby Medical Center	Adrian	Michigan	United States	49221
66	Toledo Clinic Cancer Centers - Adrian	Adrian	Michigan	United States	49221
67	Saint Joseph Mercy Cancer Center	Ann Arbor	Michigan	United States	48106-0995
68	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
69	Oakwood Cancer Center at Oakwood Hospital and Medical Center	Dearborn	Michigan	United States	48123-2500
70	Saint John Hospital and Medical Center	Detroit	Michigan	United States	48236
71	Genesys Hurley Cancer Institute	Flint	Michigan	United States	48503
72	Hurley Medical Center	Flint	Michigan	United States	48503
73	Van Elslander Cancer Center at St. John Hospital and Medical Center	Grosse Pointe Woods	Michigan	United States	48236
74	Allegiance Health	Jackson	Michigan	United States	49201
75	Foote Memorial Hospital	Jackson	Michigan	United States	49201
76	Sparrow Regional Cancer Center	Lansing	Michigan	United States	48912-1811
77	St. Mary Mercy Hospital	Livonia	Michigan	United States	48154
78	Mercy Memorial Hospital - Monroe	Monroe	Michigan	United States	48162
79	Toledo Clinic Cancer Centers - Monroe	Monroe	Michigan	United States	48162
80	St. Joseph Mercy Oakland	Pontiac	Michigan	United States	48341-2985
81	Mercy Regional Cancer Center at Mercy Hospital	Port Huron	Michigan	United States	48060
82	Seton Cancer Institute at Saint Mary's - Saginaw	Saginaw	Michigan	United States	48601
83	Lakeland Regional Cancer Care Center - St. Joseph	Saint Joseph	Michigan	United States	49085
84	Lakeside Cancer Specialists, PLLC	Saint Joseph	Michigan	United States	49085
85	Marie Yeager Cancer Center	Saint Joseph	Michigan	United States	49085
86	St. John Macomb Hospital	Warren	Michigan	United States	48093
87	Essentia Health - Duluth Clinic	Duluth	Minnesota	United States	55805-1983
88	CCOP - Duluth	Duluth	Minnesota	United States	55805
89	Miller - Dwan Medical Center	Duluth	Minnesota	United States	55805
90	Immanuel St. Joseph's	Mankato	Minnesota	United States	56002
91	Mayo Clinic Health Systems-Mankato	Mankato	Minnesota	United States	56002
92	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
93	CentraCare Clinic - River Campus	Saint Cloud	Minnesota	United States	56303
94	Coborn Cancer Center	Saint Cloud	Minnesota	United States	56303
95	Saint Cloud Hospital	Saint Cloud	Minnesota	United States	56303
96	Central Care Cancer Center-Carrie J Babb Cancer Center	Bolivar	Missouri	United States	65613
97	Southeast Cancer Center	Cape Girardeau	Missouri	United States	63703
98	Capital Region Medical Center-Goldschmidt Cancer Center	Jefferson City	Missouri	United States	65109
99	Mercy Clinic-Rolla-Cancer and Hematology	Rolla	Missouri	United States	65401
100	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
101	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65802
102	Mercy-Springfield	Springfield	Missouri	United States	65804
103	Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield	Springfield	Missouri	United States	65804
104	St. John's Regional Health Center	Springfield	Missouri	United States	65804
105	Cox Medical Center	Springfield	Missouri	United States	65807
106	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri	United States	65807
107	Montana Cancer Consortium CCOP	Billings	Montana	United States	59101
108	Saint Vincent Healthcare	Billings	Montana	United States	59101
109	Frontier Cancer Center and Blood Institutes - Billings	Billings	Montana	United States	59102
110	Billings Clinic	Billings	Montana	United States	59107-7000
111	Bozeman Deaconess Cancer Center	Bozeman	Montana	United States	59715
112	Saint James Community Hospital and Cancer Treatment Center	Butte	Montana	United States	59701
113	Benefis Healthcare - Sletten Cancer Institute	Great Falls	Montana	United States	59405
114	Saint Peter's Community Hospital	Helena	Montana	United States	59601
115	Kalispell Regional Medical Center	Kalispell	Montana	United States	59901
116	Montana Cancer Specialists	Missoula	Montana	United States	59802
117	Saint Patrick Hospital - Community Hospital	Missoula	Montana	United States	59802
118	University Medical Center of Southern Nevada	Las Vegas	Nevada	United States	89102
119	Nevada Cancer Research Foundation CCOP	Las Vegas	Nevada	United States	89106
120	Saint Joseph Hospital	Nashua	New Hampshire	United States	03060
121	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001
122	Hematology Oncology Associates of Central New York PC	East Syracuse	New York	United States	13057
123	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina	United States	27534
124	Margaret R Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
125	Rutherford Hospital	Rutherfordton	North Carolina	United States	28139
126	Toledo Clinic Cancer Centers - Bowling Green	Bowling Green	Ohio	United States	43402
127	Adena Regional Medical Center	Chillicothe	Ohio	United States	45601
128	Riverside Methodist Hospital Cancer Care	Columbus	Ohio	United States	43214-3998
129	CCOP - Columbus	Columbus	Ohio	United States	43215
130	Grant Medical Center Cancer Care	Columbus	Ohio	United States	43215
131	Mount Carmel Health - West Hospital	Columbus	Ohio	United States	43222
132	Doctors Hospital at Ohio Health	Columbus	Ohio	United States	43228
133	Grandview Hospital	Dayton	Ohio	United States	45405
134	Good Samaritan Hospital	Dayton	Ohio	United States	45406
135	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio	United States	45409
136	Samaritan North Cancer Care Center	Dayton	Ohio	United States	45415
137	CCOP - Dayton	Dayton	Ohio	United States	45420
138	Grady Memorial Hospital	Delaware	Ohio	United States	43015
139	Community Health Partners Regional Medical Center - Mercy Cancer Center	Elyria	Ohio	United States	44035
140	Hematology Oncology Center Incorporated	Elyria	Ohio	United States	44035
141	Blanchard Valley Medical Associates	Findlay	Ohio	United States	45840
142	Middletown Regional Hospital	Franklin	Ohio	United States	45005-1066
143	Wayne Hospital	Greenville	Ohio	United States	45331
144	Charles F. Kettering Memorial Hospital	Kettering	Ohio	United States	45429
145	Fairfield Medical Center	Lancaster	Ohio	United States	43130
146	Lima Memorial Hospital	Lima	Ohio	United States	45804
147	Strecker Cancer Center at Marietta Memorial Hospital	Marietta	Ohio	United States	45750
148	Toledo Radiation Oncology at Northwest Ohio Oncology Center	Maumee	Ohio	United States	43537
149	Knox Community Hospital	Mount Vernon	Ohio	United States	43050
150	Licking Memorial Cancer Care Program at Licking Memorial Hospital	Newark	Ohio	United States	43055
151	Saint Charles Hospital	Oregon	Ohio	United States	43616
152	Toledo Clinic Cancer Centers - Oregon	Oregon	Ohio	United States	43616
153	Southern Ohio Medical Center Cancer Center	Portsmouth	Ohio	United States	45662
154	Community Hospital of Springfield and Clark County	Springfield	Ohio	United States	45505
155	Flower Hospital	Sylvania	Ohio	United States	43560
156	Mercy Hospital of Tiffin	Tiffin	Ohio	United States	44883
157	The Toledo Hospital/Toledo Children's Hospital	Toledo	Ohio	United States	43606
158	Saint Vincent Mercy Medical Center	Toledo	Ohio	United States	43608
159	University of Toledo	Toledo	Ohio	United States	43614
160	Mercy Cancer Center - Saint Anne Mercy Hospital	Toledo	Ohio	United States	43623
161	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio	United States	45373-1300
162	Fulton County Health Center	Wauseon	Ohio	United States	43567
163	Mount Carmel St. Ann's Cancer Center	Westerville	Ohio	United States	43081
164	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio	United States	45385
165	Genesis - Good Samaritan Hospital	Zanesville	Ohio	United States	43701
166	Natalie Warren Bryant Cancer Center at St. Francis Hospital	Tulsa	Oklahoma	United States	74136
167	Geisinger Cancer Institute at Geisinger Health	Danville	Pennsylvania	United States	17822-0001
168	Adams Cancer Center	Gettysburg	Pennsylvania	United States	17325
169	Geisinger Hazleton Cancer Center	Hazleton	Pennsylvania	United States	18201
170	Geisinger Medical Group - Scenery Park	State College	Pennsylvania	United States	16801
171	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Wilkes-Barre	Pennsylvania	United States	18711
172	WellSpan Health-York Hospital	York	Pennsylvania	United States	17405
173	AnMed Cancer Center	Anderson	South Carolina	United States	29621
174	Cancer Centers of the Carolinas - Faris Road	Greenville	South Carolina	United States	29605
175	Greenville Cancer Center of the Carolinas (CCOP)	Greenville	South Carolina	United States	29615
176	Cancer Centers of the Carolinas-Greer Medical Oncology	Greer	South Carolina	United States	29650
177	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
178	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
179	Cancer Centers of the Carolinas - Spartanburg	Spartanburg	South Carolina	United States	29307
180	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105
181	Fredericksburg Oncology Inc.	Fredericksburg	Virginia	United States	22401
182	Marshfield Clinic Cancer Care at Regional Cancer Center	Eau Claire	Wisconsin	United States	54701
183	Gundersen Lutheran Health System/CCOP	La Crosse	Wisconsin	United States	54601
184	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin	United States	54449
185	Marshfield Clinic - Lakeland Center	Minocqua	Wisconsin	United States	54548
186	Marshfield Clinic-Minocqua Center	Minocqua	Wisconsin	United States	54548
187	Marshfield Clinic at James Beck Cancer Center	Rhinelander	Wisconsin	United States	54501
188	Ministry Medical Group at Saint Mary's Hospital	Rhinelander	Wisconsin	United States	54501
189	Marshfield Clinic - Indianhead Center	Rice Lake	Wisconsin	United States	54868
190	Marshfield Clinic-Rice Lake Center	Rice Lake	Wisconsin	United States	54868
191	Marshfield Clinic at Saint Michael's Hospital	Stevens Point	Wisconsin	United States	54481
192	Marshfield Clinic - Weston Center	Weston	Wisconsin	United States	54476
193	Marshfield Clinic - Wisconsin Rapids Center	Wisconsin Rapids	Wisconsin	United States	54494

Sponsors and Collaborators

• Alliance for Clinical Trials in Oncology
• National Cancer Institute (NCI)

Investigators

• Study Chair: Debra Barton, RN, PhD, AOCN, FAAN, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alliance for Clinical Trials in Oncology
• ClinicalTrials.gov Identifier: NCT00993928
• Other Study ID Numbers: NCCTG-N07C4; NCI-2011-01978; CDR0000656564
• First Posted: Oct 14, 2009
• Last Update Posted: Dec 3, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Alliance for Clinical Trials in Oncology: psychosocial effects of cancer and its treatment; fatigue; sleep disorders; cancer survivor
• Additional relevant MeSH terms: Sleep Wake Disorders; Parasomnias; Fatigue

Study Results

Participant Flow

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.	Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
Period Title: Overall Study
STARTED	48	45
COMPLETED	43	38
NOT COMPLETED	5	7

Baseline Characteristics

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2	Total
Arm/Group Description	Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.	Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.	Total of all reporting groups
Overall Participants	43	38	81
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55	59	57
Sex: Female, Male (Count of Participants)
Female	35 81.4%	32 84.2%	67 82.7%
Male	8 18.6%	6 15.8%	14 17.3%
Region of Enrollment (participants) [Number]
United States	43 100%	38 100%	81 100%

Outcome Measures

1. Primary Outcome

Title	Change of the (3 Day) Sleep Latency Time and Time to Fall Back Asleep After Awakening During the Night From Baseline to the End of Study at Week 7
Description	The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" > > Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

In Arm A, 4 went off treatment prior to week 7 and 2 had missing data. 23 patients were able to respond to question 6A. In Arm B, 7 did not finish 7 weeks of treatment and 1 patient had missing data. 16 patients responded to question 6A. Therefore, Q3 and Q6A are based on 37 and 23 patients in Arm A and 30 and 23 patients from Arm B, respectively.

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.> > Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.	Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.> > Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Measure Participants	37	30
Q3: Sleep Latency	-25	-45.6
Q6A: TIme to fall back Asleep	-17	-40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Home-based Sleep Intervention With Device #1, Arm B: Home-based Sleep Intervention With Device #2
	Comments	Comparison of Q3: Percent change in sleep latency from baseline to week 7.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm A: Home-based Sleep Intervention With Device #1, Arm B: Home-based Sleep Intervention With Device #2
	Comments	Comparison of Q6A: Percent change in time to fall back asleep from baseline to week 7.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.86
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Efficacy of Home-based Interventions on the Number of Awakenings After Sleep, Sleep Quality, Sleep Difficulty, and Sleep Latency at Baseline and Weeks 4 and 7.
Description	Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:> How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)> How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)> How many times did you awaken last night?> How long did it take you to get to sleep last night?> > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test.
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

In Arm A, 38 patients responded to questions during week 4 and 37 responded during week 7. In Arm B, 31 patients responded during week 4 and 30 responded during week 7.

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.	Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
Measure Participants	43	38
Sleep Difficulty: Week 4	18	37.5
Sleep Difficulty: Week 7	20	45
Sleep Quality: Week 4	13	20
Sleep Quality: Week 7	22	29
Number of Awakenings: Week 4	-40	-44
Number of Awakenings: Week 7	-50	-48
Sleep Latency: Week 4	-37	-48
Sleep Latency: Week 7	-24	-49

3. Secondary Outcome

Title	Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)
Description	The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.
Time Frame	Baseline and 7 weeks

Outcome Measure Data

Analysis Population Description

Thirty-six patients from Arm A and 31 patients from Arm B had PSQI measurements available for analysis.

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Measure Participants	36	31
Improvement	36 83.7%	48 126.3%
Worsening	3 7%	0 0%
No Chanage	61 141.9%	52 136.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Home-based Sleep Intervention With Device #1, Arm B: Home-based Sleep Intervention With Device #2
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.42
	Comments
	Method	Chi-squared
	Comments

4. Secondary Outcome

Title	Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)
Description	The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as "tense", "angry", "worn out", etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.
Time Frame	At baseline and week 7

Outcome Measure Data

Analysis Population Description

Patients that completed the POMS-B questionnaire at baseline and week 7 were used in this analysis.

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Measure Participants	34	29
Median (Full Range) [percentage of change]	7.8	7.8

5. Secondary Outcome

Title	Distress at Week 6
Description	The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.
Time Frame	From baseline to week 7

Outcome Measure Data

Analysis Population Description

All patients that completed a Distress Thermometer assessment at baseline and week 7 were included in the analysis.

Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1	Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.	Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Measure Participants	35	31
Median (Full Range) [percentage of change]	10	10

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: Home-based Sleep Intervention With Device #1, Arm B: Home-based Sleep Intervention With Device #2
	Comments	Compare percent change from baseline to week 7 Distress Thermometer score.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Adverse events were monitored weekly from week 1 to week 7.
Adverse Event Reporting Description	Regardless of whether they completed study treatment or any endpoint, all patients that began intervention and were assessed for adverse events were included in the analysis.
Arm/Group Title	Arm A: Home-based Sleep Intervention With Device #1		Arm B: Home-based Sleep Intervention With Device #2
Arm/Group Description	Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.		Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
All Cause Mortality
	Arm A: Home-based Sleep Intervention With Device #1		Arm B: Home-based Sleep Intervention With Device #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)
Serious Adverse Events
	Arm A: Home-based Sleep Intervention With Device #1		Arm B: Home-based Sleep Intervention With Device #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/44 (2.3%)		0/43 (0%)
Psychiatric disorders
Agitation	1/44 (2.3%)	2	0/43 (0%)	0
Anxiety	1/44 (2.3%)	2	0/43 (0%)	0
Other (Not Including Serious) Adverse Events
	Arm A: Home-based Sleep Intervention With Device #1		Arm B: Home-based Sleep Intervention With Device #2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/44 (50%)		18/43 (41.9%)
General disorders
Facial pain	1/44 (2.3%)	1	0/43 (0%)	0
Infections and infestations
Infections and infestations - Other, specify	0/44 (0%)	0	1/43 (2.3%)	1
Periorbital infection	1/44 (2.3%)	1	0/43 (0%)	0
Psychiatric disorders
Agitation	15/44 (34.1%)	29	10/43 (23.3%)	22
Anxiety	19/44 (43.2%)	49	15/43 (34.9%)	32

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.