Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Randomized Study of Two Home-Based Interventions for Sleep-Wake Disturbances in Cancer Survivors

Basic Trial Information

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Previous diagnosis of cancer
• No more than 2 years since finishing chemotherapy, surgery, and/or radiation therapy
• Difficulty sleeping
• No current CNS cancer or other cancer
• No obstructive sleep apnea or restless leg syndrome
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will be randomly assigned (have an equal chance of being placed) to one of two groups.

Participants in group one will receive sleep education printed materials and a guided-imagery pre-recorded mp3 device to use at home. They will meet with health care providers to learn how to use the materials. They will also receive instruction on using the pre-recorded mp3 device before bedtime for 6 weeks. Participants will go to sleep and wake at the same time every day during the study.

Participants in group two will receive sleep education printed materials and a pre-recorded mp3 device of short stories and essays to use at home. They will meet with health care providers to learn how to use the materials. They will also receive instruction on using the pre-recorded mp3 device before bedtime for 6 weeks. After finishing the study, participants will be offered the guided-imagery pre-recorded mp3 device.

All participants will fill out a 3-day sleep diary at the beginning of the study and in weeks 4 and 7. They will also fill out questionnaires at the beginning of the study, in weeks 2 and 6, and after finishing the study.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Debra Barton, RN, PhD, AOCN, FAAN, Protocol chair		Ph: 507-255-3812
Debra Barton, RN, PhD, AOCN, FAAN, Protocol chair		Ph: 507-284-4565

U.S.A.
Arizona
	Scottsdale
	Mayo Clinic Scottsdale
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Connecticut
	Hartford
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Philip Stella, MD	Ph:  734-712-1000
Idaho
	Boise
	Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
		Clinical Trials Office - Saint Alphonsus Cancer Care Center	Ph:  208-367-7954
Indiana
	Beech Grove
	St. Francis Hospital and Health Centers - Beech Grove Campus
		Howard Gross, MD	Ph:  937-832-1093
	Elkhart
	Elkhart Clinic, LLC
		Michael Method, MD, MPH	Ph:  574-237-1328
	Elkhart General Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	Michiana Hematology-Oncology, PC - Elkhart
		Michael Method, MD, MPH	Ph:  574-237-1328
	Kokomo
	Howard Community Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	La Porte
	Center for Cancer Therapy at LaPorte Hospital and Health Services
		Michael Method, MD, MPH	Ph:  574-237-1328
	Mishawaka
	Michiana Hematology-Oncology, PC - South Bend
		Michael Method, MD, MPH	Ph:  574-237-1328
	Saint Joseph Regional Medical Center
		Michael Method, MD, MPH	Ph:  574-237-1328
	Plymouth
	Michiana Hematology Oncology PC - Plymouth
		Michael Method, MD, MPH	Ph:  574-237-1328
	Richmond
	Reid Hospital & Health Care Services
		Howard Gross, MD	Ph:  937-832-1093
	South Bend
	CCOP - Northern Indiana CR Consortium
		Michael Method, MD, MPH	Ph:  574-237-1328
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Michiana Hematology-Oncology, PC - South Bend
		Michael Method, MD, MPH	Ph:  574-237-1328
	Westville
	Michiana Hematology Oncology PC - La Porte
		Michael Method, MD, MPH	Ph:  574-237-1328
Iowa
	Cedar Rapids
	Cedar Rapids Oncology Associates
		Clinical Trials Office - Cedar Rapids Oncology Associates	Ph:  319-363-2690
	Mercy Regional Cancer Center at Mercy Medical Center
		Deborah Wilbur	Ph:  319-398-6011
	Mason City
	Mercy Cancer Center at Mercy Medical Center - North Iowa
		Clinical Trials Office - Mercy Cancer Center at Mercy Medical Center - North Iowa	Ph:  641-422-6304
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
Kansas
	Chanute
	Cancer Center of Kansas, PA - Chanute
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Fort Scott
	Cancer Center of Kansas - Fort Scott
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Independence
	Cancer Center of Kansas-Independence
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Kingman
	Cancer Center of Kansas, PA - Kingman
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Lawrence
	Lawrence Memorial Hospital
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Liberal
	Cancer Center of Kansas, PA - Liberal
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Newton
	Cancer Center of Kansas, PA - Newton
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Parsons
	Cancer Center of Kansas, PA - Parsons
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Pratt
	Cancer Center of Kansas, PA - Pratt
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Wichita
	Associates in Womens Health, PA - North Review
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	CCOP - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  734-712-1000
	Saint Joseph Mercy Cancer Center
		Philip Stella, MD	Ph:  734-712-1000
	Dearborn
	Oakwood Cancer Center at Oakwood Hospital and Medical Center
		Clinical Trials Office - Oakwood Cancer Center at Oakwood Hospital and Medical Center	Ph:  313-593-8090
	Flint
	Genesys Hurley Cancer Institute
		Clinical Trials Office - Genesys Hurley Cancer Institute	Ph:  810-762-8057
	Hurley Medical Center
		Clinical Trials Office - Hurley Medical Center	Ph:  810-762-8057
	Grosse Pointe Woods
	Van Elslander Cancer Center at St. John Hospital and Medical Center
		Clincial Trials Office - Van Elslander Cancer Center at St. John Hospital and Medical Center	Ph:  313-343-3166
	Jackson
	Foote Memorial Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Lansing
	Sparrow Regional Cancer Center
		Clinical Trials Office - Sparrow Regional Cancer Center	Ph:  517-364-2890
	Livonia
	St. Mary Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Pontiac
	St. Joseph Mercy Oakland
		Philip Stella, MD	Ph:  734-712-1000
	Port Huron
	Mercy Regional Cancer Center at Mercy Hospital
		Philip Stella, MD	Ph:  734-712-1000
	Saginaw
	Seton Cancer Institute at Saint Mary's - Saginaw
		Clinical Trials Office - Seton Cancer Institute - Saginaw	Ph:  989-776-8411
	Saint Joseph
	Lakeside Cancer Specialists, PLLC
		Michael Method, MD, MPH	Ph:  574-237-1328
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Michael Method, MD, MPH	Ph:  574-237-1328
	Warren
	St. John Macomb Hospital
		Philip Stella, MD	Ph:  734-712-1000
Minnesota
	Alexandria
		Donald Jurgens
	Duluth
	CCOP - Duluth
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Duluth Clinic Cancer Center - Duluth
		Clinical Trials Office - Duluth Clinic Cancer Center - Duluth	Ph:  218-786-3308
	Miller - Dwan Medical Center
		Daniel Nikcevich, MD, PhD	Ph:  218-786-3625
	Mankato
	Immanuel St. Joseph's
		Mohmmad Ranginwala	Ph:  507-625-4031 800-327-3721
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
	Saint Cloud
	CentraCare Clinic - River Campus
		Donald Jurgens	Ph:  320-252-5131
	Coborn Cancer Center
		Donald Jurgens	Ph:  320-229-4907 877-229-4907
Missouri
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
North Carolina
	Rutherfordton
	Rutherford Hospital
		James Bearden, MD	Ph:  864-560-6812
North Dakota
	Grand Forks
	Altru Cancer Center at Altru Hospital
		Clinical Trails Office - Altru Cancer Center at Altru Hospital	Ph:  701-780-6520
Ohio
	Chillicothe
	Adena Regional Medical Center
		Clinical Trials Office - Adena Regional Medical Center	Ph:  877-779-7585
	Columbus
	CCOP - Columbus
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Doctors Hospital at Ohio Health
		Clinical Trials Office - Doctors Hospital at Ohio Health	Ph:  614-566-3275
	Grant Medical Center Cancer Care
		Clinical Trials Office - Grant Medical Center Cancer Care	Ph:  614-566-4475
	Mount Carmel Health - West Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Dayton
	CCOP - Dayton
		Howard Gross, MD	Ph:  937-832-1093
	David L. Rike Cancer Center at Miami Valley Hospital
		Clinical Trials Office - David L. Rike Cancer Center at Miami Valley Hospital	Ph:  937-208-2079
	Good Samaritan Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Grandview Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Samaritan North Cancer Care Center
		Howard Gross, MD	Ph:  937-832-1093
	Delaware
	Grady Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Findlay
	Blanchard Valley Medical Associates
		Howard Gross, MD	Ph:  937-832-1093
	Franklin
	Middletown Regional Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Greenville
	Wayne Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Kettering
	Charles F. Kettering Memorial Hospital
		Clinical Trials Office - Charles F. Kettering Memorial Hospital	Ph:  937-298-3399 ext. 57556
	Lancaster
	Fairfield Medical Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Marietta
	Strecker Cancer Center at Marietta Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Mount Vernon
	Knox Community Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Newark
	Licking Memorial Cancer Care Program at Licking Memorial Hospital
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Portsmouth
	Southern Ohio Medical Center Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Springfield
	Community Hospital of Springfield and Clark County
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Troy
	UVMC Cancer Care Center at Upper Valley Medical Center
		Clinical Trials Office - UVMC Cancer Care Center at Upper Valley Medical Center	Ph:  937-440-4842
	Westerville
	Mount Carmel St. Ann's Cancer Center
		J. Philip Kuebler, MD, PhD	Ph:  614-442-3130
	Xenia
	Ruth G. McMillan Cancer Center at Greene Memorial Hospital
		Howard Gross, MD	Ph:  937-832-1093
	Zanesville
	Genesis - Good Samaritan Hospital
		Clinical Trials Office - Genesis - Good Samaritan Hospital	Ph:  740-454-5232
Oklahoma
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Alan Keller	Ph:  918-494-2273
Pennsylvania
	Danville
	Geisinger Cancer Institute at Geisinger Health
		Clinical Trials Office - Geisinger Cancer Institute	Ph:  570-271-5251
	Hazleton
	Geisinger Hazleton Cancer Center
		Maged Khalil	Ph:  570-459-2901
	State College
	Geisinger Medical Group - Scenery Park
		Maged Khalil	Ph:  814-231-4560
	Wilkes-Barre
	Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
		Clinical Trials Office - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center	Ph:  570-271-5251
South Carolina
	Anderson
	AnMed Cancer Center
		Clinical Trials Office - AnMed Cancer Center	Ph:  864-512-1000
	Spartanburg
	CCOP - Upstate Carolina
		Clinical Trials Office - CCOP - Upstate Carolina	Ph:  800-486-5941
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
South Dakota
	Sioux Falls
	Avera Cancer Institute
		Addison Tolentino	Ph:  605-322-3000
		Addison Tolentino	Ph:  605-322-3000
West Virginia
	Huntington
	Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
		Oncology Research Supervisor	Ph:  304-399-6617
Wisconsin
	Eau Claire
	Marshfield Clinic Cancer Care at Regional Cancer Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Marshfield
	Marshfield Clinic - Marshfield Center
		Clinical Trials Office - Marshfield Clinic - Marshfield Center	Ph:  800-782-1581 ext. 94457
	Minocqua
	Marshfield Clinic - Lakeland Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Rhinelander
	Ministry Medical Group at Saint Mary's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Rice Lake
	Marshfield Clinic - Indianhead Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Stevens Point
	Marshfield Clinic at Saint Michael's Hospital
		Matthias Weiss, MD	Ph:  715-358-1266
	Weston
	Marshfield Clinic - Weston Center
		Matthias Weiss, MD	Ph:  715-358-1266
	Wisconsin Rapids
	Marshfield Clinic - Wisconsin Rapids Center
		Matthias Weiss, MD	Ph:  715-358-1266

Registry Information
Official Title		A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances
Trial Start Date		2010-04-23
Trial Completion Date		2011-05-01 (estimated)
Registered in ClinicalTrials.gov		NCT00993928
Date Submitted to PDQ		2009-09-25
Information Last Verified		2012-05-19

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