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Home-Based Programs for Improving Sleep in Cancer Survivors

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IISupportive careActive18 and overNCI, OtherCDR0000656564
NCCTG-N07C4, N07C4, NCT00993928

Trial Description

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.

Further Study Information

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 practice diary.
  • 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 Diary 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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Prior diagnosis of cancer
  • At least 2 months and ≤ 24 months since completed curative-intent treatment (chemotherapy, surgery, and/or radiotherapy)
  • Concurrent hormonal therapy (e.g., tamoxifen or aromatase inhibitors) allowed
  • 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

North Central Cancer Treatment Group

National Cancer Institute

Debra BartonStudy Chair

Teri PipeStudy Chair

Trial Sites

U.S.A.
Arizona
  Scottsdale
 Mayo Clinic Scottsdale
 Michele Y Halyard Ph: 507-538-7623
Connecticut
  Hartford
 Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi L. Venigalla Ph: 863-904-1900
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
Hawaii
  Aiea
 Kapiolani Medical Center at Pali Momi
 Jeffrey L. Berenberg Ph: 808-586-2979
  Honolulu
 Cancer Research Center of Hawaii
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Kuakini
 Jeffrey L. Berenberg Ph: 808-586-2979
 OnCare Hawaii, Incorporated - Lusitana
 Jeffrey L. Berenberg Ph: 808-586-2979
 Queen's Cancer Institute at Queen's Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
  Kailua
 Castle Medical Center
 Jeffrey L. Berenberg Ph: 808-586-2979
Idaho
  Boise
 Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
 Philip J. Stella Ph: 734-712-3456
Illinois
  Chicago
 Louis A. Weiss Memorial Hospital
 Keith L. Shulman Ph: 773-564-5044
Indiana
  Elkhart
 Elkhart Clinic, LLC
 Michael W. Method Ph: 574-237-1328
 Elkhart General Hospital
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - Elkhart
 Michael W. Method Ph: 574-237-1328
  Indianapolis
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Kokomo
 Community Cancer Care at Howard Regional Health System
 Michael W. Method Ph: 574-237-1328
  La Porte
 Center for Cancer Therapy at LaPorte Hospital and Health Services
 Michael W. Method Ph: 574-237-1328
  Mishawaka
 Michiana Hematology-Oncology, PC - Mishawaka
 Michael W. Method Ph: 574-237-1328
 Saint Joseph's Medical Center
 Michael W. Method Ph: 574-237-1328
  Plymouth
 Michiana Hematology Oncology PC - Plymouth
 Michael W. Method Ph: 574-237-1328
  South Bend
 CCOP - Northern Indiana CR Consortium
 Michael W. Method Ph: 574-237-1328
 Memorial Hospital of South Bend
 Michael W. Method Ph: 574-237-1328
 Michiana Hematology-Oncology, PC - South Bend
 Michael W. Method Ph: 574-237-1328
  Westville
 Michiana Hematology Oncology-PC Westville
 Michael W. Method Ph: 574-237-1328
Iowa
  Cedar Rapids
 Cedar Rapids Oncology Associates
 Deborah W Wilbur Ph: 319-363-2690
 Deborah W Wilbur Ph: 319-363-2690
 Mercy Regional Cancer Center at Mercy Medical Center
 Deborah W Wilbur Ph: 319-363-2690
  Mason City
 Mercy Cancer Center at Mercy Medical Center - North Iowa
 Arvind Y Vemula Ph: 800-433-3883
  Sioux City
 Mercy Medical Center - Sioux City
 Donald Bruce Wender Ph: 712-252-0088
 Siouxland Hematology-Oncology Associates, LLP
 Donald Bruce Wender Ph: 712-252-0088
 St. Luke's Regional Medical Center
 Donald Bruce Wender Ph: 712-252-0088
Kansas
  Chanute
 Cancer Center of Kansas, PA - Chanute
 Shaker R. Dakhil Ph: 316-262-4467
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker R. Dakhil Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker R. Dakhil Ph: 316-262-4467
  Fort Scott
 Cancer Center of Kansas - Fort Scott
 Shaker R. Dakhil Ph: 316-262-4467
  Independence
 Cancer Center of Kansas-Independence
 Shaker R. Dakhil Ph: 316-262-4467
  Kingman
 Cancer Center of Kansas, PA - Kingman
 Shaker R. Dakhil Ph: 316-262-4467
  Lawrence
 Lawrence Memorial Hospital
 Shaker R. Dakhil Ph: 316-262-4467
  Liberal
 Cancer Center of Kansas, PA - Liberal
 Shaker R. Dakhil Ph: 316-262-4467
  Newton
 Cancer Center of Kansas, PA - Newton
 Shaker R. Dakhil Ph: 316-262-4467
  Parsons
 Cancer Center of Kansas, PA - Parsons
 Shaker R. Dakhil Ph: 316-262-4467
  Pratt
 Cancer Center of Kansas, PA - Pratt
 Shaker R. Dakhil Ph: 316-262-4467
  Salina
 Cancer Center of Kansas, PA - Salina
 Shaker R. Dakhil Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker R. Dakhil Ph: 316-262-4467
  Wichita
 Associates in Women's Health, PA - North Hillside
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Medical Arts Tower
 Shaker R. Dakhil Ph: 316-262-4467
 Cancer Center of Kansas, PA - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 CCOP - Wichita
 Shaker R. Dakhil Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker R. Dakhil Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker R. Dakhil Ph: 316-262-4467
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 Jyotsna Fuloria Ph: 888-562-4763
  New Orleans
 New Orleans Cancer Institute at Memorial Medical Center
 Jyotsna Fuloria Ph: 888-562-4763
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 Jyotsna Fuloria Ph: 888-562-4763
Michigan
  Adrian
 Hickman Cancer Center at Bixby Medical Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Ann Arbor
 CCOP - Michigan Cancer Research Consortium
 Philip J. Stella Ph: 734-712-3456
 Saint Joseph Mercy Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Dearborn
 Oakwood Cancer Center at Oakwood Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Detroit
 Van Elslander Cancer Center at St. John Hospital and Medical Center
 Philip J. Stella Ph: 734-712-3456
  Flint
 Genesys Hurley Cancer Institute
 Philip J. Stella Ph: 734-712-3456
 Hurley Medical Center
 Philip J. Stella Ph: 734-712-3456
  Jackson
 Gayle M. Jacob Cancer Center at Allegiance Health
 Philip J. Stella Ph: 734-712-3456
  Lansing
 Sparrow Regional Cancer Center
 Philip J. Stella Ph: 734-712-3456
  Livonia
 St. Mary Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Monroe
 Community Cancer Center of Monroe
 Rex B Mowat Ph: 517-265-0116
 Mercy Memorial Hospital - Monroe
 Rex B Mowat Ph: 517-265-0116
  Pontiac
 St. Joseph Mercy Oakland
 Philip J. Stella Ph: 734-712-3456
  Port Huron
 Mercy Regional Cancer Center at Mercy Hospital
 Philip J. Stella Ph: 734-712-3456
  Saginaw
 Seton Cancer Institute at Saint Mary's - Saginaw
 Philip J. Stella Ph: 734-712-3456
  Saint Joseph
 Lakeside Cancer Specialists, PLLC
 Michael W. Method Ph: 574-237-1328
  St. Joseph
 Lakeland Regional Cancer Care Center - St. Joseph
 Michael W. Method Ph: 574-237-1328
  Warren
 St. John Macomb Hospital
 Philip J. Stella Ph: 734-712-3456
Minnesota
  Mankato
 Immanuel St. Joseph's
 Mohmmad J Ranginwala Ph: 507-385-2929
  Rochester
 Mayo Clinic Cancer Center
 Michele Y Halyard Ph: 507-538-7623
  Saint Cloud
 CentraCare Clinic - Women and Children
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
 Coborn Cancer Center
 Donald J Jurgens Ph: 877-229-4907
  Email: coborncancercenter@centracare.com
Missouri
  Bolivar
 Central Care Cancer Center at Carrie J. Babb Cancer Center
 Robert L Carolla Ph: 417-269-4520
  Cape Girardeau
 Southeast Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Jefferson City
 Goldschmidt Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Rolla
 Mercy Clinic Cancer and Hematology - Rolla
 Robert L Carolla Ph: 417-269-4520
  Saint Louis
 Missouri Baptist Cancer Center
 Alan Philip Lyss Ph: 800-392-0936
  Springfield
 Cancer Research for the Ozarks
 Robert L Carolla Ph: 417-269-4520
 Hulston Cancer Center at Cox Medical Center South
 Robert L Carolla Ph: 417-269-4520
 St. John's Regional Health Center
 Robert L Carolla Ph: 417-269-4520
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 Hematology-Oncology Centers of the Northern Rockies - Billings
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
 Montana Cancer Specialists at Montana Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
New Hampshire
  Nashua
 Oncology Center at St. Joseph Hospital
 Mary Ann Voltz Ph: 603-880-3408
  Email: carcieri@sjh-nh.org
New York
  East Syracuse
 CCOP - Hematology-Oncology Associates of Central New York
 Jeffrey J. Kirshner Ph: 315-472-7504
North Carolina
  Hendersonville
 Comprehensive Cancer Center at Pardee Hospital
 James E. Radford Ph: 828-696-4716
Ohio
  Bowling Green
 Wood County Oncology Center
 Rex B Mowat Ph: 517-265-0116
  Chillicothe
 Adena Regional Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Columbus
 CCOP - Columbus
 J. Philip Kuebler Ph: 614-566-3275
 Doctors Hospital at Ohio Health
 J. Philip Kuebler Ph: 502-361-8496
 Grant Medical Center Cancer Care
 J. Philip Kuebler Ph: 614-566-3275
 Mount Carmel Health - West Hospital
 J. Philip Kuebler Ph: 614-566-3275
 Riverside Methodist Hospital Cancer Care
 J. Philip Kuebler Ph: 502-361-8496
  Delaware
 Grady Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Elyria
 Hematology Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Mercy Cancer Center - Elyria
 Rex B Mowat Ph: 517-265-0116
  Lancaster
 Fairfield Medical Center
 J. Philip Kuebler Ph: 614-566-3275
  Lima
 Lima Memorial Hospital
 Rex B Mowat Ph: 517-265-0116
  Marietta
 Strecker Cancer Center at Marietta Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Maumee
 Northwest Ohio Oncology Center
 Rex B Mowat Ph: 517-265-0116
 Rex B Mowat Ph: 517-265-0116
  Mount Vernon
 Knox Community Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Newark
 Licking Memorial Cancer Care Program at Licking Memorial Hospital
 J. Philip Kuebler Ph: 614-566-3275
  Oregon
 St. Charles Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic - Oregon
 Rex B Mowat Ph: 517-265-0116
  Portsmouth
 Southern Ohio Medical Center Cancer Center
 J. Philip Kuebler Ph: 502-361-8496
  Springfield
 Community Hospital of Springfield and Clark County
 J. Philip Kuebler Ph: 614-566-3275
  Sylvania
 Flower Hospital Cancer Center
 Rex B Mowat Ph: 517-265-0116
  Tiffin
 Mercy Hospital of Tiffin
 Rex B Mowat Ph: 517-265-0116
  Toledo
 St. Anne Mercy Hospital
 Rex B Mowat Ph: 517-265-0116
 St. Vincent Mercy Medical Center
 Rex B Mowat Ph: 517-265-0116
 Toledo Clinic, Incorporated - Main Clinic
 Rex B Mowat Ph: 517-265-0116
 Toledo Hospital
 Rex B Mowat Ph: 517-265-0116
 University of Toledo Medical Center
 Rex B Mowat Ph: 517-265-0116
  Wauseon
 Fulton County Health Center
 Rex B Mowat Ph: 517-265-0116
  Westerville
 Mount Carmel St. Ann's Cancer Center
 J. Philip Kuebler Ph: 614-566-3275
  Zanesville
 Genesis - Good Samaritan Hospital
 J. Philip Kuebler Ph: 614-566-3275
Pennsylvania
  Danville
 Geisinger Cancer Institute at Geisinger Health
 Maged F Khalil Ph: 570-271-5251
  Gettysburg
 Adams Cancer Center
 Amir Tabatabai Ph: 877-441-7957
  Hazleton
 Geisinger Hazleton Cancer Center
 Maged F Khalil Ph: 570-271-5251
  State College
 Geisinger Medical Group - Scenery Park
 Maged F Khalil Ph: 570-271-5251
  Wilkes-Barre
 Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
 Maged F Khalil Ph: 570-271-5251
  York
 WellSpan Health
 Amir Tabatabai Ph: 877-441-7957
South Carolina
  Greenville
 Cancer Centers of the Carolinas - Faris Road
 Jeffrey Kent Giguere Ph: 864-241-6251
 Cancer Centers of the Carolinas - Grove Commons
 Jeffrey Kent Giguere Ph: 864-241-6251
 CCOP - Greenville
 Jeffrey Kent Giguere Ph: 864-241-6251
 Greenville Memorial Hospital
 Jeffrey Kent Giguere Ph: 864-241-6251
  Greer
 Cancer Centers of the Carolinas - Greer Medical Oncology
 Jeffrey Kent Giguere Ph: 864-241-6251
  Seneca
 Cancer Centers of the Carolinas - Seneca
 Jeffrey Kent Giguere Ph: 864-241-6251
  Spartanburg
 Cancer Centers of the Carolinas - Spartanburg
 Jeffrey Kent Giguere Ph: 864-241-6251
South Dakota
  Sioux Falls
 Avera Cancer Institute
 Addison R Tolentino Ph: 800-657-4377
  Email: Jan.Healy@avera.org
Virginia
  Fredericksburg
 Fredericksburg Oncology Inc
 Rex B Mowat Ph: 517-265-0116
Wisconsin
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Matthias Weiss Ph: 800-347-0673
  Marshfield
 Marshfield Clinic - Marshfield Center
 Matthias Weiss Ph: 800-347-0673
  Minocqua
 Marshfield Clinic - Lakeland Center
 Matthias Weiss Ph: 800-347-0673
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Matthias Weiss Ph: 800-347-0673
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Matthias Weiss Ph: 800-347-0673
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Matthias Weiss Ph: 800-347-0673
  Weston
 Marshfield Clinic - Weston Center
 Matthias Weiss Ph: 800-347-0673
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Matthias Weiss Ph: 800-347-0673

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00993928
Information obtained from ClinicalTrials.gov on February 21, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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