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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00993928
First received: October 13, 2009
Last updated: July 1, 2016
Last verified: July 2016
  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
Primary Completion Date: September 2014 (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   (Adult, Senior)
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

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Locations
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, Connecticut
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
Florida Hospital - Orlando
Orlando, Florida, United States, 32803
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
United States, Hawaii
Oncare Hawaii, Incorporated - Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817-3169
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Ochsner Baptist Medical Center
New Orleans, Louisiana, United States, 70115
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Toledo Clinic Cancer Centers - Adrian
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Allegiance Health
Jackson, Michigan, United States, 49201
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers - Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Essentia Health - Duluth Clinic
Duluth, Minnesota, United States, 55805-1983
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56002
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic - River Campus
Saint Cloud, Minnesota, United States, 56303
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States, 65613
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Mercy-Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield
Springfield, Missouri, United States, 65804
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Cox Medical Center
Springfield, Missouri, United States, 65807
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Frontier Cancer Center and Blood Institutes - Billings
Billings, Montana, United States, 59102
Billings Clinic
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare - Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
United States, New Hampshire
Saint Joseph Hospital
Nashua, New Hampshire, United States, 03060
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Hematology Oncology Associates of Central New York PC
East Syracuse, New York, United States, 13057
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, Ohio
Toledo Clinic Cancer Centers - Bowling Green
Bowling Green, Ohio, United States, 43402
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
CCOP - Columbus
Columbus, Ohio, United States, 43215
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
CCOP - Dayton
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Community Health Partners Regional Medical Center - Mercy Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Radiation Oncology at Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers - Oregon
Oregon, Ohio, United States, 43616
Southern Ohio Medical Center Cancer Center
Portsmouth, Ohio, United States, 45662
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
University of Toledo
Toledo, Ohio, United States, 43614
Mercy Cancer Center - Saint Anne Mercy Hospital
Toledo, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health
Danville, Pennsylvania, United States, 17822-0001
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Geisinger Hazleton Cancer Center
Hazleton, Pennsylvania, United States, 18201
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
WellSpan Health-York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
Cancer Centers of the Carolinas - Faris Road
Greenville, South Carolina, United States, 29605
Greenville Cancer Center of the Carolinas (CCOP)
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
United States, Virginia
Fredericksburg Oncology Inc.
Fredericksburg, Virginia, United States, 22401
United States, Wisconsin
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Gundersen Lutheran Health System/CCOP
La Crosse, Wisconsin, United States, 54601
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, United States, 54548
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Marshfield Clinic at Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
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
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
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: July 1, 2016
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
Sleep Wake Disorders
Parasomnias
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Mental Disorders

ClinicalTrials.gov processed this record on August 24, 2016