Trial record 1 of 1 for:    NCT00993928
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Home-Based Programs for Improving Sleep in Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier:
NCT00993928
First received: October 13, 2009
Last updated: August 8, 2013
Last verified: October 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of poor and good sleepers according to the two cutoff points of the PSQI total score at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Side effects [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: Yes ]
  • Overall adherence rate [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients reporting an improvement in sleep at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
  • Total mood disturbance and each of the subscale measured by POMS-B [ Time Frame: Up to 7 weeks ] [ Designated as safety issue: No ]
  • The proportion of patients reporting mild to moderate distress at week 6 [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: April 2010
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993928

  Hide Study Locations
Locations
United States, Arizona
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Philip J. Stella, MD    734-712-1000      
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi L. Venigalla, MD    508-368-3168      
Florida Hospital - Orlando Recruiting
Orlando, Florida, United States, 32803
Contact: Lee M. Zehngebot, MD    407-898-5452      
United States, Georgia
Phoebe Putney Memorial Hospital Recruiting
Albany, Georgia, United States, 31701
Contact: Chirag Jani, M.D.    229-312-7141      
United States, Hawaii
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii, Incorporated - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
University of Hawaii Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
OnCare Hawaii, Incorporated - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817-3169
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Straub Clinic and Hospital, Incorporated Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
Oncare Hawaii Inc-POB II Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Jeffrey Berenberg, M.D.    808-524-6115      
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Contact: Jeffrey L. Berenberg, MD    808-433-4089      
Wilcox Memorial Hospital and Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Contact: Jeffrey Berenberg, M.D.    808-433-4089      
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Philip Stella, M.D.    734-712-4931      
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Clinical Trials Office - Saint Alphonsus Cancer Care Center    208-367-7954      
United States, Illinois
Weiss Memorial Hospital Recruiting
Chicago, Illinois, United States, 60640
Contact: Keith Shulman, M.D.    773-564-5022      
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Howard M. Gross, MD    937-832-1093      
Elkhart Clinic, LLC Recruiting
Elkhart, Indiana, United States, 46514-2098
Contact: Michael W. Method, MD, MPH    574-237-1328      
Michiana Hematology-Oncology, PC - Elkhart Recruiting
Elkhart, Indiana, United States, 46514
Contact: Michael W. Method, MD, MPH    574-237-1328      
Elkhart General Hospital Recruiting
Elkhart, Indiana, United States, 46515
Contact: Michael W. Method, MD, MPH    574-237-1328      
Community Howard Regional Health Recruiting
Kokomo, Indiana, United States, 46904
Contact: Michael Method, M.D.    574-237-1328      
Howard Community Hospital Recruiting
Kokomo, Indiana, United States, 46904
Contact: Michael W. Method, MD, MPH    574-237-1328      
Center for Cancer Therapy at LaPorte Hospital and Health Services Recruiting
La Porte, Indiana, United States, 46350
Contact: Michael W. Method, MD, MPH    574-237-1328      
Michiana Hematology-Oncology, PC - South Bend Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael W. Method, MD, MPH    574-237-1328      
Saint Joseph Regional Medical Center Recruiting
Mishawaka, Indiana, United States, 46545-1470
Contact: Michael W. Method, MD, MPH    574-237-1328      
Michiana Hematology Oncology PC - Plymouth Recruiting
Plymouth, Indiana, United States, 46563
Contact: Michael W. Method, MD, MPH    574-237-1328      
Reid Hospital & Health Care Services Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    937-832-1093      
Michiana Hematology Oncology PC-South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael Method, M.D.    574-237-1328      
Memorial Hospital of South Bend Recruiting
South Bend, Indiana, United States, 46601
Contact: Clinical Trials Office - Memorial Hospital of South Bend    800-284-7370      
CCOP - Northern Indiana CR Consortium Recruiting
South Bend, Indiana, United States, 46601
Contact: Michael W. Method, MD, MPH    574-237-1328      
Michiana Hematology Oncology PC - La Porte Recruiting
Westville, Indiana, United States, 46391
Contact: Michael W. Method, MD, MPH    574-237-1328      
United States, Iowa
Cedar Rapids Oncology Associates Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Clinical Trials Office - Cedar Rapids Oncology Associates    319-363-2690      
Mercy Regional Cancer Center at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah W. Wilbur    319-398-6011      
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah Wilbur    319-363-8303      
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Alexandria Thomas, M.D.    319-356-2425      
Mercy Cancer Center at Mercy Medical Center - North Iowa Recruiting
Mason City, Iowa, United States, 50401
Contact: Clinical Trials Office - Mercy Cancer Center at Mercy Medical    641-422-6304      
St. Luke's Regional Medical Center Recruiting
Sioux City, Iowa, United States, 51104
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Mercy Medical Center - Sioux City Recruiting
Sioux City, Iowa, United States, 51102
Contact: Donald B. Wender, MD, PhD    712-252-0088      
Siouxland Hematology-Oncology Associates, LLP Recruiting
Sioux City, Iowa, United States, 51101
Contact: Donald B. Wender, MD, PhD    712-252-0088      
United States, Kansas
Cancer Center of Kansas, PA - Chanute Recruiting
Chanute, Kansas, United States, 66720
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Independence Recruiting
Independence, Kansas, United States, 67301
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Kingman Recruiting
Kingman, Kansas, United States, 67068
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas-Liberal Recruiting
Liberal, Kansas, United States, 67901
Contact: Shaker Dakhil, M.D.    316-262-4467      
Cancer Center of Kansas, PA - Newton Recruiting
Newton, Kansas, United States, 67114
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Parsons Recruiting
Parsons, Kansas, United States, 67357
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Pratt Recruiting
Pratt, Kansas, United States, 67124
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Salina Recruiting
Salina, Kansas, United States, 67401
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wellington Recruiting
Wellington, Kansas, United States, 67152
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Associates in Womens Health, PA - North Review Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Via Christi Cancer Center at Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
CCOP - Wichita Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
Cancer Center of Kansas, PA - Winfield Recruiting
Winfield, Kansas, United States, 67156
Contact: Shaker R. Dakhil, MD, FACP    316-262-4467      
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: Jyotsna Fuloria, M.D.    504-842-3910      
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: Jyotsna Fuloria, M.D.    504-842-3910      
Ochsner Cancer Institute at Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Jyotsna Fuloria    504-842-4360      
United States, Michigan
Toledo Clinic Cancer Centers - Adrian Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex Mowat    517-263-2507      
Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex Mowat    517-263-2507      
Saint Joseph Mercy Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48106-0995
Contact: Philip J. Stella, MD    734-712-1000      
CCOP - Michigan Cancer Research Consortium Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Philip J. Stella, MD    734-712-1000      
Oakwood Cancer Center at Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48123-2500
Contact: Clinical Trials Office - Oakwood Cancer Center at Oakwood Hosp    313-593-8090      
Saint John Hospital and Medical Center Recruiting
Detroit, Michigan, United States, 48236
Contact: Philip J. Stella    610-402-2273      
Hurley Medical Center Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Hurley Medical Center    810-762-8057      
Genesys Hurley Cancer Institute Recruiting
Flint, Michigan, United States, 48503
Contact: Clinical Trials Office - Genesys Hurley Cancer Institute    810-762-8057      
Van Elslander Cancer Center at St. John Hospital and Medical Center Recruiting
Grosse Pointe Woods, Michigan, United States, 48236
Contact: Clincial Trials Office - Van Elslander Cancer Center at St. Jo    313-343-3166      
Allegiance Health Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella    610-402-2273      
Foote Memorial Hospital Recruiting
Jackson, Michigan, United States, 49201
Contact: Philip J. Stella, MD    734-712-1000      
Sparrow Regional Cancer Center Recruiting
Lansing, Michigan, United States, 48912-1811
Contact: Clinical Trials Office - Sparrow Regional Cancer Center    517-364-2890      
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Memorial Hospital - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    734-240-8400      
Toledo Clinic Cancer Centers - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex Mowat    517-263-2507      
St. Joseph Mercy Oakland Recruiting
Pontiac, Michigan, United States, 48341-2985
Contact: Philip J. Stella, MD    734-712-1000      
Mercy Regional Cancer Center at Mercy Hospital Recruiting
Port Huron, Michigan, United States, 48060
Contact: Philip J. Stella, MD    734-712-1000      
Seton Cancer Institute at Saint Mary's - Saginaw Recruiting
Saginaw, Michigan, United States, 48601
Contact: Clinical Trials Office - Seton Cancer Institute - Saginaw    989-776-8411      
Lakeland Regional Cancer Care Center - St. Joseph Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michael W. Method, MD, MPH    574-237-1328      
Marie Yeager Cancer Center Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michael Method, M.D.    574-237-1328      
Lakeside Cancer Specialists, PLLC Recruiting
Saint Joseph, Michigan, United States, 49085
Contact: Michael W. Method, MD, MPH    574-237-1328      
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
Contact: Philip J. Stella, MD    734-712-1000      
United States, Minnesota
Essentia Health - Duluth Clinic Recruiting
Duluth, Minnesota, United States, 55805-1983
Contact: Clinical Trials Office - Essentia Health - Duluth Clinic    218-786-3308      
CCOP - Duluth Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Miller - Dwan Medical Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Daniel Nikcevich, MD, PhD    218-786-3625      
Mayo Clinic Health Systems-Mankato Recruiting
Mankato, Minnesota, United States, 56002
Contact: Mohmmad Ranginwala    507-345-2929      
Immanuel St. Joseph's Recruiting
Mankato, Minnesota, United States, 56002
Contact: Mohmmad J. Ranginwala    507-625-4031      
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
CentraCare Clinic - River Campus Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-252-5131      
Coborn Cancer Center Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald J. Jurgens    320-229-4907      
Saint Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Donald Jurgens    320-229-4907      
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center Recruiting
Bolivar, Missouri, United States, 65613
Contact: Jay Carlson, M.D.    417-820-3554      
Southeast Cancer Center Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Bryan A. Faller    573-651-5550      
Capital Region Medical Center-Goldschmidt Cancer Center Recruiting
Jefferson City, Missouri, United States, 65109
Contact: Bryan Faller, M.D.    314-996-6955      
Mercy Clinic-Rolla-Cancer and Hematology Recruiting
Rolla, Missouri, United States, 65401
Contact: Robert Carolla, M.D.    417-269-4520      
Missouri Baptist Cancer Center Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Bryan A. Faller    314-996-5569      
CCOP - Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65802
Contact: Robert L. Carolla    417-269-4520      
Mercy-Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert Carolla, M.D.    417-269-4520      
Hulston Cancer Center at Cox Medical Center South Recruiting
Springfield, Missouri, United States, 65807
Contact: Robert L. Carolla    417-269-5257      
Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert Carolla    417-269-4570      
St. John's Regional Health Center Recruiting
Springfield, Missouri, United States, 65804
Contact: Robert L. Carolla    417-820-2000      
Cox Medical Center Recruiting
Springfield, Missouri, United States, 65807
Contact: Jay Carlson, M.D.    417-820-3554      
United States, Montana
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    610-402-2273      
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    610-402-2273      
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    610-402-2273      
Frontier Cancer Center and Blood Institutes - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin Marchello    610-402-2273      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
Saint James Community Hospital and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello    610-402-2273      
Benefis Healthcare - Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    610-402-2273      
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    610-402-2273      
Kalispell Regional Medical Center Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    610-402-2273      
Montana Cancer Specialists Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    610-402-2273      
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John A. Ellerton, MD, CM    702-384-0013      
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John Ellerton    702-383-7336      
United States, New Hampshire
Saint Joseph Hospital Recruiting
Nashua, New Hampshire, United States, 03060
Contact: Mary Voltz, M.D.    603-880-3408      
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263-0001
Contact: Ellis G. Levine, MD    716-845-8547      
Hematology Oncology Associates of Central New York PC Recruiting
East Syracuse, New York, United States, 13057
Contact: Jeffrey Kirshner    315-472-7504      
United States, North Carolina
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
Margaret R Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Contact: James Radford, M.D.    828-692-8045      
Rutherford Hospital Recruiting
Rutherfordton, North Carolina, United States, 28139
Contact: James D. Bearden, MD    864-560-6812      
United States, Ohio
Toledo Clinic Cancer Centers - Bowling Green Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Rex Mowat    517-263-2507      
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Contact: Clinical Trials Office - Adena Regional Medical Center    877-779-7585      
Mount Carmel Health - West Hospital Recruiting
Columbus, Ohio, United States, 43222
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Grant Medical Center Cancer Care Recruiting
Columbus, Ohio, United States, 43215
Contact: Clinical Trials Office - Grant Medical Center Cancer Care    614-566-4475      
CCOP - Columbus Recruiting
Columbus, Ohio, United States, 43215
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Riverside Methodist Hospital Cancer Care Recruiting
Columbus, Ohio, United States, 43214-3998
Contact: Clinical Trials Office - Riverside Methodist Hospital Cancer C    614-566-4475      
Doctors Hospital at Ohio Health Recruiting
Columbus, Ohio, United States, 43228
Contact: Clinical Trials Office - Doctors Hospital at Ohio Health    614-566-3275      
David L. Rike Cancer Center at Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Clinical Trials Office - David L. Rike Cancer Center at Miami    937-208-2079      
Samaritan North Cancer Care Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard M. Gross, MD    937-832-1093      
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
CCOP - Dayton Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross, MD    937-832-1093      
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Hematology Oncology Center Incorporated Recruiting
Elyria, Ohio, United States, 44035
Contact: Rex Mowat, M.D.    517-263-2507      
Community Health Partners Regional Medical Center - Mercy Cancer Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Rex Mowat    517-263-2507      
Blanchard Valley Medical Associates Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard M. Gross, MD    937-832-1093      
Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross, MD    937-832-1093      
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Charles F. Kettering Memorial Hospital Recruiting
Kettering, Ohio, United States, 45429
Contact: Clinical Trials Office - Charles F. Kettering Memorial Hospita    937-298-3399 ext 57556      
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Rex Mowat    517-263-2507      
Strecker Cancer Center at Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Toledo Radiation Oncology at Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex Mowat    517-263-2507      
Knox Community Hospital Recruiting
Mount Vernon, Ohio, United States, 43050
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Licking Memorial Cancer Care Program at Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Toledo Clinic Cancer Centers - Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex Mowat    517-263-2507      
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex Mowat    517-263-2507      
Southern Ohio Medical Center Cancer Center Recruiting
Portsmouth, Ohio, United States, 45662
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Community Hospital of Springfield and Clark County Recruiting
Springfield, Ohio, United States, 45505
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Rex Mowat, M.D.    517-263-2507      
Mercy Hospital of Tiffin Recruiting
Tiffin, Ohio, United States, 44883
Contact: Rex B. Mowat    419-447-3130      
Saint Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Rex Mowat    517-263-2507      
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Rex Mowat    517-263-2507      
Mercy Cancer Center - Saint Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat    517-263-2507      
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex Mowat    517-263-2507      
UVMC Cancer Care Center at Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373-1300
Contact: Clinical Trials Office - UVMC Cancer Care Center at Upper Vall    937-440-4842      
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Rex Mowat    517-263-2507      
Mount Carmel St. Ann's Cancer Center Recruiting
Westerville, Ohio, United States, 43081
Contact: J. Philip Kuebler, MD, PhD    614-442-3130      
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard M. Gross, MD    937-832-1093      
Genesis - Good Samaritan Hospital Recruiting
Zanesville, Ohio, United States, 43701
Contact: Clinical Trials Office - Genesis - Good Samaritan Hospital    740-454-5232      
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Alan M. Keller    918-494-2273      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Adams Cancer Center Recruiting
Gettysburg, Pennsylvania, United States, 17325
Contact: Amir Tabatabai    717-741-8124      
Geisinger Hazleton Cancer Center Recruiting
Hazleton, Pennsylvania, United States, 18201
Contact: Maged F. Khalil    570-459-2901      
Geisinger Medical Group - Scenery Park Recruiting
State College, Pennsylvania, United States, 16801
Contact: Maged F. Khalil    814-231-4560      
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Clinical Trials Office - Frank M. and Dorothea Henry Cancer Ce    570-271-5251      
WellSpan Health-York Hospital Recruiting
York, Pennsylvania, United States, 17405
Contact: Amir Tabatabai, M.D.    717-741-9229      
United States, South Carolina
AnMed Cancer Center Recruiting
Anderson, South Carolina, United States, 29621
Contact: Clinical Trials Office - AnMed Cancer Center    864-512-1000      
Greenville Cancer Center of the Carolinas (CCOP) Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey Giguere, M.D.    864-522-3065      
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
Cancer Centers of the Carolinas-Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: Jeffrey Giguere, M.D.    864-241-6251      
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
CCOP - Upstate Carolina Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - CCOP - Upstate Carolina    800-486-5941      
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Recruiting
Spartanburg, South Carolina, United States, 29303
Contact: Clinical Trials Office - Gibbs Regional Cancer Center    800-486-5941      
United States, South Dakota
Avera Cancer Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Addison R. Tolentino    605-322-3000      
United States, Virginia
Fredericksburg Oncology Inc. Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Rex Mowat    517-263-2507      
United States, Wisconsin
Marshfield Clinic Cancer Care at Regional Cancer Center Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Matthias Weiss, MD    715-358-1266      
Gundersen Lutheran Health System/CCOP Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Michael Ojelabi, M.D.    608-782-7300      
Marshfield Clinic - Marshfield Center Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Clinical Trials Office - Marshfield Clinic - Marshfield Center    800-782-1581 ext 94457      
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Matthias Weiss, M.D.    715-358-1853      
Marshfield Clinic - Lakeland Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Matthias Weiss, MD    715-358-1266      
Marshfield Clinic at James Beck Cancer Center Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Matthias Weiss, M.D.    715-358-1853      
Ministry Medical Group at Saint Mary's Hospital Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Matthias Weiss, MD    715-358-1266      
Marshfield Clinic - Indianhead Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Matthias Weiss, MD    715-358-1266      
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Matthias Weiss, M.D.    715-358-1853      
Marshfield Clinic at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Matthias Weiss, MD    715-358-1266      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Matthias Weiss, MD    715-358-1266      
Marshfield Clinic - Wisconsin Rapids Center Recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Matthias Weiss, MD    715-358-1266      
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Study Chair: Debra Barton, RN, PhD, AOCN, FAAN Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology ( North Central Cancer Treatment Group )
ClinicalTrials.gov Identifier: NCT00993928     History of Changes
Other Study ID Numbers: NCCTG-N07C4, NCI-2011-01978, CDR0000656564
Study First Received: October 13, 2009
Last Updated: August 8, 2013
Health Authority: United States: Institutional Review Board

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:
Fatigue
Parasomnias
Sleep Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014