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AzTrials

Cancer SurvivorPhase 2NCT00993928

Home-Based Programs for Improving Sleep in Cancer Survivors

A Phase 2 study testing Home-based sleep intervention in people with Cancer Survivor and Fatigue, run by Alliance for Clinical Trials in Oncology at 193 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Home-based sleep intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
193 sitesUnited States
Study dates
Apr 2010to 1 May 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

193 sites in 1 country.

193 sites in 1 country

United States193 sites

  • Oncare Hawaii, Incorporated - Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Toledo Clinic Cancer Centers - Adrian

    Adrian, Michigan, 49221

  • Phoebe Putney Memorial Hospital

    Albany, Georgia, 31701

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Ochsner Clinic Foundation-Baton Rouge

    Baton Rouge, Louisiana, 70809

  • St. Francis Hospital and Health Centers - Beech Grove Campus

    Beech Grove, Indiana, 46107

  • Montana Cancer Consortium CCOP

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Frontier Cancer Center and Blood Institutes - Billings

    Billings, Montana, 59102

  • Billings Clinic

    Billings, Montana, 59107-7000

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Central Care Cancer Center-Carrie J Babb Cancer Center

    Bolivar, Missouri, 65613

  • Toledo Clinic Cancer Centers - Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Cedar Rapids Oncology Associates

    Cedar Rapids, Iowa, 52403

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Mercy Regional Cancer Center at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • CCOP - Dayton

    Dayton, Ohio, 45420

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health - Duluth Clinic

    Duluth, Minnesota, 55805-1983

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller - Dwan Medical Center

    Duluth, Minnesota, 55805

  • Hematology Oncology Associates of Central New York PC

    East Syracuse, New York, 13057

  • Marshfield Clinic Cancer Care at Regional Cancer Center

    Eau Claire, Wisconsin, 54701

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology-Oncology, PC - Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Community Health Partners Regional Medical Center - Mercy Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Blanchard Valley Medical Associates

    Findlay, Ohio, 45840

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Fredericksburg Oncology Inc.

    Fredericksburg, Virginia, 22401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Benefis Healthcare - Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Cancer Centers of the Carolinas - Faris Road

    Greenville, South Carolina, 29605

  • Greenville Cancer Center of the Carolinas (CCOP)

    Greenville, South Carolina, 29615

  • Cancer Centers of the Carolinas-Greer Medical Oncology

    Greer, South Carolina, 29650

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Geisinger Hazleton Cancer Center

    Hazleton, Pennsylvania, 18201

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Oncare Hawaii Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • University of Hawaii

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817-3169

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Castle Medical Center

    Kailua, Hawaii, 96734

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Howard Community Hospital

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Health System/CCOP

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67901

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67901

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Immanuel St. Joseph's

    Mankato, Minnesota, 56002

  • Mayo Clinic Health Systems-Mankato

    Mankato, Minnesota, 56002

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Mercy Cancer Center at Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Toledo Radiation Oncology at Northwest Ohio Oncology Center

    Maumee, Ohio, 43537

  • Marshfield Clinic - Lakeland Center

    Minocqua, Wisconsin, 54548

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Michiana Hematology-Oncology, PC - South Bend

    Mishawaka, Indiana, 46545-1470

  • Saint Joseph Regional Medical Center

    Mishawaka, Indiana, 46545-1470

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Mercy Memorial Hospital - Monroe

    Monroe, Michigan, 48162

  • Toledo Clinic Cancer Centers - Monroe

    Monroe, Michigan, 48162

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Saint Joseph Hospital

    Nashua, New Hampshire, 03060

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

  • Ochsner Cancer Institute at Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Toledo Clinic Cancer Centers - Oregon

    Oregon, Ohio, 43616

  • Florida Hospital - Orlando

    Orlando, Florida, 32803

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Michiana Hematology Oncology PC - Plymouth

    Plymouth, Indiana, 46563

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Southern Ohio Medical Center Cancer Center

    Portsmouth, Ohio, 45662

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Ministry Medical Group at Saint Mary's Hospital

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic - Indianhead Center

    Rice Lake, Wisconsin, 54868

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • Reid Hospital & Health Care Services

    Richmond, Indiana, 47374

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

  • Lakeland Regional Cancer Care Center - St. Joseph

    Saint Joseph, Michigan, 49085

  • Lakeside Cancer Specialists, PLLC

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51102

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Centers of the Carolinas - Spartanburg

    Spartanburg, South Carolina, 29307

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • Mercy-Springfield

    Springfield, Missouri, 65804

  • Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield

    Springfield, Missouri, 65804

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Cox Medical Center

    Springfield, Missouri, 65807

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Missouri Baptist Cancer Center

    St Louis, Missouri, 63131

  • Geisinger Medical Group - Scenery Park

    State College, Pennsylvania, 16801

  • Marshfield Clinic at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Flower Hospital

    Sylvania, Ohio, 43560

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • The Toledo Hospital/Toledo Children's Hospital

    Toledo, Ohio, 43606

  • Saint Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • University of Toledo

    Toledo, Ohio, 43614

  • Mercy Cancer Center - Saint Anne Mercy Hospital

    Toledo, Ohio, 43623

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373-1300

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Fulton County Health Center

    Wauseon, Ohio, 43567

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Michiana Hematology Oncology PC - La Porte

    Westville, Indiana, 46391

  • 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 - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • WellSpan Health-York Hospital

    York, Pennsylvania, 17405

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Home-based sleep intervention
Keywords
psychosocial effects of cancer and its treatment, fatigue, sleep disorders, cancer survivor
Medical subject headings
Fatigue, Sleep Wake Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based sleep interventionBehavioural

    Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.

Study groups in NCT00993928
Study groupRoleWhat they receive
Arm A: Home-based sleep intervention with Device #1ExperimentalParticipants 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.
Receives: Behavioral: Home-based sleep intervention
Arm B: Home-based sleep intervention with Device #2Active comparatorParticipants 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.
Receives: Behavioral: Home-based sleep intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    The primary analysis will compare the change in time (in minutes) to fall asleep from baseline to week 7 as reported by question 3 in the sleep diary: "How long did it take you to get to sleep last night?" and time to fall back asleep after awakening during the night as reported by question 6A on sleep dairy: "When waking up after first falling asleep, how long did it take you to fall back to sleep?" >

    > Data were analyzed as a percent change from baseline to week 7. The percent change were compared between arms using a Wilcoxon rank-sum test.

    Measured: Baseline and 7 weeks

Secondary outcomes (4)

  1. 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.

    Overall efficacy was analyzed as a composite of 4 outcomes: 1. sleep difficulty, 2. sleep quality, 3. Number of awakenings, and 4. Sleep latency. These 4 outcomes were measured by the responses to the following questions, respectively:>

    1. How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)>
    2. How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)>
    3. How many times did you awaken last night?>
    4. How long did it take you to get to sleep last night?> > The 4 questions were analyzed as percent change from baseline after week 4 and after week 7. The percent change between arms was analyzed using a Wilcoxon test.

    Measured: Baseline and 7 weeks

  2. Comparing the Efficacy of Two Home-based Sleep Interventions as Therapy for Sleep-wake Disturbances as Measured by the Percent of People Who Show Improved Sleep Per the Pittsburgh Sleep Quality Index (PSQI)

    The PSQI has 19 items and seven component scales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep-wake disturbances, use of sleep medication, and daytime dysfunction. The scoring algorithm yields seven component scales on 0-3 scales which are summed to produce a global score on a 0-21 scale with higher values representing more severe sleep difficulty. The percentage of patients that showed improvement or worsening in sleep score from baseline to Week 7 were analyzed and compared using a Chi-squared test.

    Measured: Baseline and 7 weeks

  3. Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B)

    The POMS-B is a shortened version of the original POMS with 30 items each asking the patient to select how he/she has been feeling during the past week with respect to an adjective such as "tense", "angry", "worn out", etc., on a 0-4 scale (0=not at all; 4=extremely). The POMS-B consists of six identifiable mood states (tension/anxiety, depression/dejection, anger/hostility, vigor/activity, fatigue/inertia, and confusion/bewilderment) and measures the patient's total mood disturbance. This study analyzed total mood disturbance (total scale score) as a secondary endpoints. Possible weekly scores ranged from 0-120. Week 7 scores were analyzed as a percentage change from baseline with a negative score representing a worsening condition. A Wilcoxon rank-sum test was used to compare treatment arms.

    Measured: At baseline and week 7

  4. Distress at Week 6

    The Distress Thermometer is a single-item tool which asks patients to describe how much distress he/she has been experiencing in the past week on a scale of 0 to 10 (0=no distress, 10=extreme distress). The Distress Thermometer was selected for this study due to its brevity. Week 7 distress measures were analyzed as percent change from baseline and analyzed between arms with a t-test.

    Measured: From baseline to week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2009 (estimated)
  2. Study startApr 2010
  3. Primary completionMar 2014
  4. Study completion1 May 2019

Why it stopped: Poor accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00993928
Sponsor's protocol ID
NCCTG-N07C4
Other IDs
NCI-2011-01978, CDR0000656564
Status last verified
Nov 2019
First submitted
13 Oct 2009
Last updated
3 Dec 2019
Data monitoring committee
Yes

Publications

  • Barton DL, Atherton PJ, Satele DV, Qin R, Dakhil S, Pipe T, Hobday T, Fee-Schroeder K, Loprinzi CL. A randomized phase II trial evaluating two non-pharmacologic interventions in cancer survivors for the treatment of sleep-wake disturbances: NCCTG N07C4 (Alliance). Support Care Cancer. 2020 Dec;28(12):6085-6094. doi: 10.1007/s00520-020-05461-6. Epub 2020 Apr 19.

    PubMed 32307658

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Home-based sleep intervention in people with Cancer Survivor and Fatigue, run by Alliance for Clinical Trials in Oncology at 193 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 193 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: Baseline and 7 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00993928, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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