Home-Based Programs for Improving Sleep in Cancer Survivors

November 25, 2019 updated by: Alliance for Clinical Trials in Oncology

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Behavioral: Home-based sleep intervention

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Arizona
  - Scottsdale, Arizona, United States, 85259-5499
    - Mayo Clinic Scottsdale
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Florida
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  - Orlando, Florida, United States, 32803
    - Florida Hospital - Orlando
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Oncare Hawaii, Incorporated - Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - 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 Inc-POB II
  - Honolulu, Hawaii, United States, 96817-3169
    - OnCare Hawaii, Incorporated - Kuakini
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Regional Medical Center
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Illinois
  - Chicago, Illinois, United States, 60640
    - Weiss Memorial Hospital
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas-Liberal
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas, PA - Liberal
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - 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, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Clinic Foundation-Baton Rouge
  - New Orleans, Louisiana, United States, 70115
    - Ochsner Baptist Medical Center
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Toledo Clinic Cancer Centers - Adrian
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48236
    - Saint John Hospital and Medical Center
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers - Monroe
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Duluth, Minnesota, United States, 55805-1983
    - Essentia Health - Duluth Clinic
  - Mankato, Minnesota, United States, 56002
    - Immanuel St. Joseph's
  - Mankato, Minnesota, United States, 56002
    - Mayo Clinic Health Systems-Mankato
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Cancer Center
  - Saint Cloud, Minnesota, United States, 56303
    - Saint Cloud Hospital
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center-Carrie J Babb Cancer Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Medical Center-Goldschmidt Cancer Center
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - Springfield, Missouri, United States, 65807
    - Cox Medical Center
  - Springfield, Missouri, United States, 65804
    - Mercy-Springfield
  - Springfield, Missouri, United States, 65804
    - Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59101
    - Montana Cancer Consortium CCOP
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic
  - Billings, Montana, United States, 59102
    - Frontier Cancer Center and Blood Institutes - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - Great Falls, Montana, United States, 59405
    - Benefis Healthcare - Sletten Cancer Institute
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Hampshire
  - Nashua, New Hampshire, United States, 03060
    - Saint Joseph Hospital
- New York
  - Buffalo, New York, United States, 14263-0001
    - Roswell Park Cancer Institute
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York PC
- North Carolina
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
- Ohio
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers - Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Elyria, Ohio, United States, 44035
    - Community Health Partners Regional Medical Center - Mercy Cancer Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Oncology Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers - Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center Cancer Center
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Cancer Center - Saint Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Pennsylvania
  - Danville, Pennsylvania, United States, 17822-0001
    - Geisinger Cancer Institute at Geisinger Health
  - Gettysburg, Pennsylvania, United States, 17325
    - Adams Cancer Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Hazleton Cancer Center
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group - Scenery Park
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  - York, Pennsylvania, United States, 17405
    - WellSpan Health-York Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29615
    - Greenville Cancer Center of the Carolinas (CCOP)
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas-Greer Medical Oncology
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc.
- Wisconsin
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Clinic Cancer Care at Regional Cancer Center
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Health System/CCOP
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic - Marshfield Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Rhinelander, Wisconsin, United States, 54501
    - Marshfield Clinic at James Beck Cancer Center
  - Rhinelander, Wisconsin, United States, 54501
    - Ministry Medical Group at Saint Mary's Hospital
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic-Rice Lake Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Stevens Point, Wisconsin, United States, 54481
    - Marshfield Clinic at Saint Michael's Hospital
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic - Weston Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline and 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Baseline and 7 weeks	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:> How difficult was it to get to sleep last night? (scale 1-5, 5 meaning very easy)> How deeply did you sleep last night? (scale 1-5, 5 meaning very deeply)> How many times did you awaken last night?> 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.	Baseline and 7 weeks
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) Time Frame: Baseline and 7 weeks	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.	Baseline and 7 weeks
Total Mood Disturbance as Measured by Profiles of Mood States B (POMS-B) Time Frame: At baseline and week 7	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.	At baseline and week 7
Distress at Week 6 Time Frame: From baseline to week 7	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.	From baseline to week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

October 13, 2009

First Submitted That Met QC Criteria

October 13, 2009

First Posted (Estimate)

October 14, 2009

Study Record Updates

Last Update Posted (Actual)

December 3, 2019

Last Update Submitted That Met QC Criteria

November 25, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCCTG-N07C4
NCI-2011-01978 (Registry Identifier: CTRP (Clinical Trials Reporting System))
CDR0000656564 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Home-Based Programs for Improving Sleep in Cancer Survivors

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers