Fatigue Clinical Trial
Official title:
A Randomized Phase II Trial Evaluating Two Non-pharmacologic Interventions in Cancer Survivors for the Treatment of Sleep-wake Disturbances
Verified date | November 2019 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 93 |
Est. completion date | May 1, 2019 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Oncare Hawaii, Incorporated - Pali Momi | 'Aiea | Hawaii |
United States | Pali Momi Medical Center | 'Aiea | Hawaii |
United States | Bixby Medical Center | Adrian | Michigan |
United States | Toledo Clinic Cancer Centers - Adrian | Adrian | Michigan |
United States | Phoebe Putney Memorial Hospital | Albany | Georgia |
United States | AnMed Cancer Center | Anderson | South Carolina |
United States | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan |
United States | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan |
United States | Ochsner Clinic Foundation-Baton Rouge | Baton Rouge | Louisiana |
United States | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana |
United States | Billings Clinic | Billings | Montana |
United States | Frontier Cancer Center and Blood Institutes - Billings | Billings | Montana |
United States | Montana Cancer Consortium CCOP | Billings | Montana |
United States | Saint Vincent Healthcare | Billings | Montana |
United States | Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Saint Alphonsus Regional Medical Center | Boise | Idaho |
United States | Central Care Cancer Center-Carrie J Babb Cancer Center | Bolivar | Missouri |
United States | Toledo Clinic Cancer Centers - Bowling Green | Bowling Green | Ohio |
United States | Bozeman Deaconess Cancer Center | Bozeman | Montana |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Saint James Community Hospital and Cancer Treatment Center | Butte | Montana |
United States | Southeast Cancer Center | Cape Girardeau | Missouri |
United States | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa |
United States | Mercy Hospital | Cedar Rapids | Iowa |
United States | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa |
United States | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas |
United States | Weiss Memorial Hospital | Chicago | Illinois |
United States | Adena Regional Medical Center | Chillicothe | Ohio |
United States | CCOP - Columbus | Columbus | Ohio |
United States | Doctors Hospital at Ohio Health | Columbus | Ohio |
United States | Grant Medical Center Cancer Care | Columbus | Ohio |
United States | Mount Carmel Health - West Hospital | Columbus | Ohio |
United States | Riverside Methodist Hospital Cancer Care | Columbus | Ohio |
United States | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania |
United States | CCOP - Dayton | Dayton | Ohio |
United States | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio |
United States | Good Samaritan Hospital | Dayton | Ohio |
United States | Grandview Hospital | Dayton | Ohio |
United States | Samaritan North Cancer Care Center | Dayton | Ohio |
United States | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan |
United States | Grady Memorial Hospital | Delaware | Ohio |
United States | Saint John Hospital and Medical Center | Detroit | Michigan |
United States | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | Essentia Health - Duluth Clinic | Duluth | Minnesota |
United States | Miller - Dwan Medical Center | Duluth | Minnesota |
United States | Hematology Oncology Associates of Central New York PC | East Syracuse | New York |
United States | Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire | Wisconsin |
United States | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas |
United States | Elkhart Clinic, LLC | Elkhart | Indiana |
United States | Elkhart General Hospital | Elkhart | Indiana |
United States | Michiana Hematology-Oncology, PC - Elkhart | Elkhart | Indiana |
United States | Community Health Partners Regional Medical Center - Mercy Cancer Center | Elyria | Ohio |
United States | Hematology Oncology Center Incorporated | Elyria | Ohio |
United States | Blanchard Valley Medical Associates | Findlay | Ohio |
United States | Genesys Hurley Cancer Institute | Flint | Michigan |
United States | Hurley Medical Center | Flint | Michigan |
United States | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas |
United States | Middletown Regional Hospital | Franklin | Ohio |
United States | Fredericksburg Oncology Inc. | Fredericksburg | Virginia |
United States | Adams Cancer Center | Gettysburg | Pennsylvania |
United States | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina |
United States | Benefis Healthcare - Sletten Cancer Institute | Great Falls | Montana |
United States | Cancer Centers of the Carolinas - Faris Road | Greenville | South Carolina |
United States | Greenville Cancer Center of the Carolinas (CCOP) | Greenville | South Carolina |
United States | Wayne Hospital | Greenville | Ohio |
United States | Cancer Centers of the Carolinas-Greer Medical Oncology | Greer | South Carolina |
United States | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan |
United States | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut |
United States | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania |
United States | Saint Peter's Community Hospital | Helena | Montana |
United States | Margaret R Pardee Memorial Hospital | Hendersonville | North Carolina |
United States | Kapiolani Medical Center for Women and Children | Honolulu | Hawaii |
United States | Oncare Hawaii Inc-POB II | Honolulu | Hawaii |
United States | OnCare Hawaii, Incorporated - Kuakini | Honolulu | Hawaii |
United States | Queen's Medical Center | Honolulu | Hawaii |
United States | Straub Clinic and Hospital, Incorporated | Honolulu | Hawaii |
United States | University of Hawaii | Honolulu | Hawaii |
United States | Cancer Center of Kansas-Independence | Independence | Kansas |
United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
United States | Allegiance Health | Jackson | Michigan |
United States | Foote Memorial Hospital | Jackson | Michigan |
United States | Capital Region Medical Center-Goldschmidt Cancer Center | Jefferson City | Missouri |
United States | Castle Medical Center | Kailua | Hawaii |
United States | Kalispell Regional Medical Center | Kalispell | Montana |
United States | Charles F. Kettering Memorial Hospital | Kettering | Ohio |
United States | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas |
United States | Community Howard Regional Health | Kokomo | Indiana |
United States | Howard Community Hospital | Kokomo | Indiana |
United States | Gundersen Lutheran Health System/CCOP | La Crosse | Wisconsin |
United States | Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte | Indiana |
United States | Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland | Florida |
United States | Fairfield Medical Center | Lancaster | Ohio |
United States | Sparrow Regional Cancer Center | Lansing | Michigan |
United States | Nevada Cancer Research Foundation CCOP | Las Vegas | Nevada |
United States | University Medical Center of Southern Nevada | Las Vegas | Nevada |
United States | Lawrence Memorial Hospital | Lawrence | Kansas |
United States | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas |
United States | Cancer Center of Kansas-Liberal | Liberal | Kansas |
United States | Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue | Hawaii |
United States | Lima Memorial Hospital | Lima | Ohio |
United States | St. Mary Mercy Hospital | Livonia | Michigan |
United States | Immanuel St. Joseph's | Mankato | Minnesota |
United States | Mayo Clinic Health Systems-Mankato | Mankato | Minnesota |
United States | Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio |
United States | Marshfield Clinic - Marshfield Center | Marshfield | Wisconsin |
United States | Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City | Iowa |
United States | Toledo Radiation Oncology at Northwest Ohio Oncology Center | Maumee | Ohio |
United States | Marshfield Clinic - Lakeland Center | Minocqua | Wisconsin |
United States | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin |
United States | Michiana Hematology-Oncology, PC - South Bend | Mishawaka | Indiana |
United States | Saint Joseph Regional Medical Center | Mishawaka | Indiana |
United States | Montana Cancer Specialists | Missoula | Montana |
United States | Saint Patrick Hospital - Community Hospital | Missoula | Montana |
United States | Mercy Memorial Hospital - Monroe | Monroe | Michigan |
United States | Toledo Clinic Cancer Centers - Monroe | Monroe | Michigan |
United States | Knox Community Hospital | Mount Vernon | Ohio |
United States | Saint Joseph Hospital | Nashua | New Hampshire |
United States | Ochsner Baptist Medical Center | New Orleans | Louisiana |
United States | Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans | Louisiana |
United States | Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio |
United States | Cancer Center of Kansas, PA - Newton | Newton | Kansas |
United States | Saint Charles Hospital | Oregon | Ohio |
United States | Toledo Clinic Cancer Centers - Oregon | Oregon | Ohio |
United States | Florida Hospital - Orlando | Orlando | Florida |
United States | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas |
United States | Michiana Hematology Oncology PC - Plymouth | Plymouth | Indiana |
United States | St. Joseph Mercy Oakland | Pontiac | Michigan |
United States | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan |
United States | Southern Ohio Medical Center Cancer Center | Portsmouth | Ohio |
United States | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas |
United States | Marshfield Clinic at James Beck Cancer Center | Rhinelander | Wisconsin |
United States | Ministry Medical Group at Saint Mary's Hospital | Rhinelander | Wisconsin |
United States | Marshfield Clinic - Indianhead Center | Rice Lake | Wisconsin |
United States | Marshfield Clinic-Rice Lake Center | Rice Lake | Wisconsin |
United States | Reid Hospital & Health Care Services | Richmond | Indiana |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | Mercy Clinic-Rolla-Cancer and Hematology | Rolla | Missouri |
United States | Rutherford Hospital | Rutherfordton | North Carolina |
United States | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan |
United States | CentraCare Clinic - River Campus | Saint Cloud | Minnesota |
United States | Coborn Cancer Center | Saint Cloud | Minnesota |
United States | Saint Cloud Hospital | Saint Cloud | Minnesota |
United States | Lakeland Regional Cancer Care Center - St. Joseph | Saint Joseph | Michigan |
United States | Lakeside Cancer Specialists, PLLC | Saint Joseph | Michigan |
United States | Marie Yeager Cancer Center | Saint Joseph | Michigan |
United States | Missouri Baptist Cancer Center | Saint Louis | Missouri |
United States | Cancer Center of Kansas, PA - Salina | Salina | Kansas |
United States | Mayo Clinic Scottsdale | Scottsdale | Arizona |
United States | Mercy Medical Center - Sioux City | Sioux City | Iowa |
United States | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa |
United States | St. Luke's Regional Medical Center | Sioux City | Iowa |
United States | Avera Cancer Institute | Sioux Falls | South Dakota |
United States | CCOP - Northern Indiana CR Consortium | South Bend | Indiana |
United States | Memorial Hospital of South Bend | South Bend | Indiana |
United States | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana |
United States | Cancer Centers of the Carolinas - Spartanburg | Spartanburg | South Carolina |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina |
United States | CCOP - Cancer Research for the Ozarks | Springfield | Missouri |
United States | Community Hospital of Springfield and Clark County | Springfield | Ohio |
United States | Cox Medical Center | Springfield | Missouri |
United States | Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri |
United States | Mercy-Springfield | Springfield | Missouri |
United States | Ozark Health Ventures LLC dba Cancer Research for the Ozarks - Springfield | Springfield | Missouri |
United States | St. John's Regional Health Center | Springfield | Missouri |
United States | Geisinger Medical Group - Scenery Park | State College | Pennsylvania |
United States | Marshfield Clinic at Saint Michael's Hospital | Stevens Point | Wisconsin |
United States | Flower Hospital | Sylvania | Ohio |
United States | Mercy Hospital of Tiffin | Tiffin | Ohio |
United States | Mercy Cancer Center - Saint Anne Mercy Hospital | Toledo | Ohio |
United States | Saint Vincent Mercy Medical Center | Toledo | Ohio |
United States | The Toledo Hospital/Toledo Children's Hospital | Toledo | Ohio |
United States | University of Toledo | Toledo | Ohio |
United States | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio |
United States | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma |
United States | St. John Macomb Hospital | Warren | Michigan |
United States | Fulton County Health Center | Wauseon | Ohio |
United States | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas |
United States | Mount Carmel St. Ann's Cancer Center | Westerville | Ohio |
United States | Marshfield Clinic - Weston Center | Weston | Wisconsin |
United States | Michiana Hematology Oncology PC - La Porte | Westville | Indiana |
United States | Associates in Womens Health, PA - North Review | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas |
United States | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas |
United States | CCOP - Wichita | Wichita | Kansas |
United States | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas |
United States | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania |
United States | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas |
United States | Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids | Wisconsin |
United States | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio |
United States | WellSpan Health-York Hospital | York | Pennsylvania |
United States | Genesis - Good Samaritan Hospital | Zanesville | Ohio |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Baseline and 7 weeks | |
Secondary | 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: 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 | |
Secondary | 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. | Baseline and 7 weeks | |
Secondary | 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. | At baseline and week 7 | |
Secondary | 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. | From baseline to week 7 |
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