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A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances

Phase 2
18 Years
Open (Enrolling)
Cancer Survivor, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders

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Trial Information

A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances



- 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


- 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.

Inclusion Criteria


- 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)


- 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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

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

Safety Issue:


Principal Investigator

Debra Barton, RN, PhD, AOCN, FAAN

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic



Study ID:




Start Date:

April 2010

Completion Date:

Related Keywords:

  • Cancer Survivor
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • psychosocial effects of cancer and its treatment
  • fatigue
  • sleep disorders
  • cancer survivor
  • Fatigue
  • Sleep Disorders
  • Parasomnias



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
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Cedar Rapids Oncology Associates Cedar Rapids, Iowa  52403
Mercy Medical Center - Sioux City Sioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLP Sioux City, Iowa  51101
St. Luke's Regional Medical Center Sioux City, Iowa  51104
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
Saint Joseph Mercy Cancer Center Ann Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical Center Dearborn, Michigan  48123-2500
Genesys Hurley Cancer Institute Flint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical Center Grosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
St. John Macomb Hospital Warren, Michigan  48093
Duluth Clinic Cancer Center - Duluth Duluth, Minnesota  55805-1983
CCOP - Duluth Duluth, Minnesota  55805
Miller - Dwan Medical Center Duluth, Minnesota  55805
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
Geisinger Medical Group - Scenery Park State College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center Wilkes-Barre, Pennsylvania  18711
Marshfield Clinic - Marshfield Center Marshfield, Wisconsin  54449
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Memorial Hospital of South Bend South Bend, Indiana  46601
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Columbus Columbus, Ohio  43206
CCOP - Dayton Kettering, Ohio  45429
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Saint Joseph Regional Medical Center South Bend, Indiana  46617
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Via Christi Cancer Center at Via Christi Regional Medical Center Wichita, Kansas  67214
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
Geisinger Cancer Institute at Geisinger Health Danville, Pennsylvania  17822-0001
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center Hartford, Connecticut  06105
Elkhart General Hospital Elkhart, Indiana  46515
Howard Community Hospital Kokomo, Indiana  46904
South Bend Clinic South Bend, Indiana  46617
Lakeland Regional Cancer Care Center - St. Joseph St. Joseph, Michigan  49085
Mount Carmel Health - West Hospital Columbus, Ohio  43222
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte, Indiana  46350
Mercy Regional Cancer Center at Mercy Medical Center Cedar Rapids, Iowa  52403
Cancer Center of Kansas, PA - Dodge City Dodge City, Kansas  67801
St. Joseph's Medical Center Brainerd, Minnesota  56401
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Mercy Cancer Center at Mercy Medical Center - North Iowa Mason City, Iowa  50401
Altru Cancer Center at Altru Hospital Grand Forks, North Dakota  58201
Michiana Hematology-Oncology, PC - Elkhart Elkhart, Indiana  46514
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La Porte La Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South Bend Mishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - Plymouth Plymouth, Indiana  46563
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cancer Center of Kansas, PA - Chanute Chanute, Kansas  66720
Cancer Center of Kansas, PA - El Dorado El Dorado, Kansas  67042
Cancer Center of Kansas - Fort Scott Fort Scott, Kansas  66701
Cancer Center of Kansas-Independence Independence, Kansas  67301
Cancer Center of Kansas, PA - Kingman Kingman, Kansas  67068
Lawrence Memorial Hospital Lawrence, Kansas  66044
Cancer Center of Kansas, PA - Newton Newton, Kansas  67114
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
Cancer Center of Kansas, PA - Pratt Pratt, Kansas  67124
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
Cancer Center of Kansas, PA - Wichita Wichita, Kansas  67214
Associates in Womens Health, PA - North Review Wichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts Tower Wichita, Kansas  67208
Cancer Center of Kansas, PA - Winfield Winfield, Kansas  67156
Foote Memorial Hospital Jackson, Michigan  49201
St. Mary Mercy Hospital Livonia, Michigan  48154
Michiana Hematology Oncology PC - Niles Niles, Michigan  49120
St. Joseph Mercy Oakland Pontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Mary Rutan Hospital Bellefontaine, Ohio  43311
Grant Medical Center Cancer Care Columbus, Ohio  43215
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Clinton Memorial Hospital Wilmington, Ohio  45177
Adventist Medical Center Portland, Oregon  97216
Geisinger Hazleton Cancer Center Hazleton, Pennsylvania  18201
Marshfield Clinic Cancer Care at Regional Cancer Center Eau Claire, Wisconsin  54701
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's Hospital Rhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's Hospital Stevens Point, Wisconsin  54481
Marshfield Clinic - Weston Center Weston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
AnMed Cancer Center Anderson, South Carolina  29621
Immanuel St. Joseph's Mankato, Minnesota  56002