Home-Based Programs for Improving Sleep in Cancer Survivors
NCT ID: NCT00993928
Last Updated: 2019-12-03
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
93 participants
INTERVENTIONAL
2010-04-30
2019-05-01
Brief Summary
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PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
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.
Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Interventions
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Home-based sleep intervention
Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Debra Barton, RN, PhD, AOCN, FAAN
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States
Florida Hospital - Orlando
Orlando, Florida, United States
Phoebe Putney Memorial Hospital
Albany, Georgia, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States
University of Hawaii
Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Oncare Hawaii, Incorporated - Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Weiss Memorial Hospital
Chicago, Illinois, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States
Elkhart Clinic, LLC
Elkhart, Indiana, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States
Reid Hospital & Health Care Services
Richmond, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Bixby Medical Center
Adrian, Michigan, United States
Toledo Clinic Cancer Centers - Adrian
Adrian, Michigan, United States
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Foote Memorial Hospital
Jackson, Michigan, United States
Sparrow Regional Cancer Center
Lansing, Michigan, United States
St. Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States
Toledo Clinic Cancer Centers - Monroe
Monroe, Michigan, United States
St. Joseph Mercy Oakland
Pontiac, Michigan, United States
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
St. John Macomb Hospital
Warren, Michigan, United States
Essentia Health - Duluth Clinic
Duluth, Minnesota, United States
CCOP - Duluth
Duluth, Minnesota, United States
Miller - Dwan Medical Center
Duluth, Minnesota, United States
Immanuel St. Joseph's
Mankato, Minnesota, United States
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States
Coborn Cancer Center
Saint Cloud, Minnesota, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States
Southeast Cancer Center
Cape Girardeau, Missouri, United States
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Mercy-Springfield
Springfield, Missouri, United States
Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield
Springfield, Missouri, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Cox Medical Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Frontier Cancer Center and Blood Institutes - Billings
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare - Sletten Cancer Institute
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Saint Joseph Hospital
Nashua, New Hampshire, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Hematology Oncology Associates of Central New York PC
East Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Rutherford Hospital
Rutherfordton, North Carolina, United States
Toledo Clinic Cancer Centers - Bowling Green
Bowling Green, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Grant Medical Center Cancer Care
Columbus, Ohio, United States
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Doctors Hospital at Ohio Health
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital
Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States
Samaritan North Cancer Care Center
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Community Health Partners Regional Medical Center - Mercy Cancer Center
Elyria, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Blanchard Valley Medical Associates
Findlay, Ohio, United States
Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Oncology Center
Maumee, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers - Oregon
Oregon, Ohio, United States
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Mercy Cancer Center - Saint Anne Mercy Hospital
Toledo, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
AnMed Cancer Center
Anderson, South Carolina, United States
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States
Greenville Cancer Center of the Carolinas (CCOP)
Greenville, South Carolina, United States
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Fredericksburg Oncology Inc.
Fredericksburg, Virginia, United States
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States
Gundersen Lutheran Health System/CCOP
La Crosse, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
Countries
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References
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Barton DL, Atherton PJ, Satele DV, Qin R, Dakhil S, Pipe T, Hobday T, Fee-Schroeder K, Loprinzi CL. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance). Support Care Cancer. 2020 Dec;28(12):6085-6094. doi: 10.1007/s00520-020-05461-6. Epub 2020 Apr 19.
Other Identifiers
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NCI-2011-01978
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000656564
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N07C4
Identifier Type: -
Identifier Source: org_study_id
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