 |
Clinical Trial Questions?
|
|
|
Randomized Study of Stress Management Therapy in Patients Undergoing Chemotherapy for Cancer
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information
Alternate Title
Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| No phase specified | Educational/Counseling/Training, Supportive care | Active | 18 and over | MCC-0501
HLMCC 0501, NCT00377130 |
Special Category:
NCI Web site featured trial Objectives Primary - Determine if a self-administered stress management intervention is effective in improving quality of life and decreasing psychological distress (anxiety and depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.
Secondary - Determine if the degree of acculturation in Hispanics influences the observed helpfulness of the intervention.
Entry Criteria Disease Characteristics:
- Newly diagnosed with cancer
- Scheduled to receive ≥ 4 courses of intravenous chemotherapy
- Not scheduled to receive radiotherapy prior to the end of course 4
- No severe depression or other severe psychiatric disorders
Prior/Concurrent Therapy:
- See Disease Characteristics
- No prior intravenous chemotherapy
Patient Characteristics:
- Able to read and speak English or Spanish
Expected Enrollment 442A total of 442 patients will be accrued for this study. Outcomes Primary Outcome(s)Quality of life
Anxiety
Depression
Secondary Outcome(s)Degree of acculturation
Outline This is a randomized, multicenter study. Patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs non-Hispanic). Patients are randomized to 1 of 2 arms. - Arm I (self-administered stress management training plus usual psychosocial care): Patients receive a video DVD, audio CD, and brochure that provides information and instruction in 3 stress management training techniques (progressive muscle relaxation training and guided imagery, abdominal breathing, and coping skills training) to use during chemotherapy. Patients also receive usual psychosocial care.
- Arm II (usual psychosocial care only): Patients receive usual psychosocial care.
Patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4.
Trial Contact Information
Trial Lead Organizations H. Lee Moffitt Cancer Center CCOP Research Base | | | | Teletia Taylor, PhD, Protocol chair | | | | | Susan McMillan, PhD, RN, FAAN, Protocol co-chair | | | |
Trial Sites
|
|
|
|
| U.S.A. |
|
| California |
|
| |
Martinez |
|
| | | | | Contra Costa Regional Medical Center |
| | | Sharon Hiner, MD | |
| | Email:
csoppe@bati.org |
|
| |
Oakland |
|
| | | Bay Area Tumor Institute |
| | | James Feusner, MD | |
| | Email:
mmcgreevy@bati.org |
| | | CCOP - Bay Area Tumor Institute |
| | | James Feusner, MD | |
| | Email:
mmcgreevy@bati.org |
|
| District of Columbia |
|
| |
Washington |
|
| | | | Howard University Cancer Center |
| | | Teletia Taylor, PhD | |
| | Email:
nsangabriel@huhosp.org |
|
| Illinois |
|
| |
Chicago |
|
| | | | John H. Stroger, Jr. Hospital of Cook County |
| | | Howard Zaren, MD, FACS | |
| | Email:
wendyarogowski@yahoo.com |
| | | MBCCOP - JHS Hospital of Cook County |
| | | Howard Zaren, MD, FACS | |
| | Email:
wendyaragowski@yahooo.com |
|
| Louisiana |
|
| |
Mamou |
|
| | | | Savoy Medical Center |
| | | Glenn Mills, MD | |
| | Email:
cindybalfa@centurytel.net |
|
| |
Monroe |
|
| | | Louisiana State University Health Sciences Center - Monroe |
| | | Glenn Mills, MD | |
| | Email:
jdupuy@lsuhsc.edu |
|
| |
Shreveport |
|
| | | Feist-Weiller Cancer Center at Louisiana State University Health Sciences |
| | | Glenn Mills, MD | |
| | Email:
sadams1@lsuhsc.edu |
| | | Veterans Affairs Medical Center - Shreveport |
| | | Glenn Mills, MD | |
| | Email:
sadams1@lsuhsc.edu |
|
| Michigan |
|
| |
Royal Oak |
|
| | | | CCOP - Beaumont |
| | | David Decker, MD, FACP | |
| | Email:
carcher@beaumont.edu |
| | | William Beaumont Hospital - Royal Oak Campus |
| | | David Decker, MD, FACP | |
| | Email:
cfeczko@beaumont.edu |
|
| |
Troy |
|
| | | William Beaumont Hospital - Troy Campus |
| | | David Decker, MD, FACP | |
| | Email:
rgrantham@beaumont.edu |
|
| Minnesota |
|
| |
Bemidji |
|
| | | | MeritCare Bemidji |
| | | Homayoon Shahidi, MD | |
| | Email:
susan.hudson@meritcare.com |
|
| Missouri |
|
| |
Springfield |
|
| | | | CCOP - Cancer Research for the Ozarks |
| | | John Goodwin, MD | |
| | Email:
cwagoner@sprg.mercy.net |
| | | Hulston Cancer Center at Cox Medical Center South |
| | | John Goodwin, MD | |
| | Email:
kim.heiser@coxhealth.com |
| | | St. John's Regional Health Center |
| | | John Goodwin, MD | |
| | Email:
cwagoner@sprg.mercy.net |
|
| New Jersey |
|
| |
Newark |
|
| | | | Newark Beth Israel Medical Center |
| | | Peter Wiernik, MD | |
| | Email:
mcostin@sbhcs.com |
|
| New York |
|
| |
Bronx |
|
| | | | Our Lady of Mercy Medical Center Comprehensive Cancer Center |
| | | Peter Wiernik, MD | |
| | Email:
lsacris@olmhs.org |
|
| |
White Plains |
|
| | | Dickstein Cancer Treatment Center at White Plains Hospital Center |
| | | Peter Wiernik, MD | |
| | Email:
kduffy@wphospital.org |
|
| North Carolina |
|
| |
Goldsboro |
|
| | | | CCOP - Southeast Cancer Control Consortium |
| | | James Atkins, MD | |
| | Email:
bslate@wfubmc.edu |
| | | Southeastern Medical Oncology Center - Goldsboro |
| | | James Atkins, MD | |
| | Email:
dthompson@cancersmoc.com |
|
| |
Hendersonville |
|
| | | Pardee Memorial Hospital |
| | | James Radford, MD | |
| | Email:
karen.morris@pardeehospital.org |
|
| |
High Point |
|
| | | High Point Regional Hospital |
| | | George Sanders, MD | |
| | Email:
kreid@hprhs.com |
|
| |
Statesville |
|
| | | Iredell Memorial Hospital |
| | | Ruby Grimm, MD | |
| | Email:
rene.atwell@iredellmemorial.org |
|
| |
Wilson |
|
| | | Southeastern Medical Oncology Center - Wilson |
| | | James Atkins, MD | |
| | Email:
aevans@cancersmoc.com |
|
| |
Winston-Salem |
|
| | | Forsyth Regional Cancer Center at Forsyth Medical Center |
| | | James Atkins, MD | |
| | Email:
ecwhite@novanthealth.org |
|
| North Dakota |
|
| |
Fargo |
|
| | | | CCOP - MeritCare Hospital |
| | | Preston Steen, MD | |
| | Email:
angela.nordstrom@meritcare.com |
| | | Roger Maris Cancer Center at MeritCare Hospital |
| | | Preston Steen, MD | |
| | Email:
angela.nordstrom@meritcare.com |
|
| Ohio |
|
| |
Chillicothe |
|
| | | | Adena Regional Medical Center |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
akarshner@adena.org |
|
| |
Columbus |
|
| | | CCOP - Columbus |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
johnsonp@sorcc.org |
| | | Doctors Hospital at Ohio Health |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
mboren@ohiohealth.com |
| | | Grant Medical Center Cancer Care |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
mbrimer@ohiohealth.com |
| | | Mount Carmel Health - West Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
ggatti@mchs.com |
| | | Mount Carmel Hospital East |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
rzacks@mchs.com |
| | | Mount Carmel St. Ann's Cancer Center |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
sdevictor@mchs.com |
| | | Riverside Methodist Hospital Cancer Care |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
jharvey@ohiohealth.com |
|
| |
Delaware |
|
| | | Grady Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
vmaggard@gradyhospital.com |
|
| |
Marietta |
|
| | | Strecker Cancer Center at Marietta Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
jlupardus@mmhospital.org |
|
| |
Newark |
|
| | | Licking Memorial Cancer Care Program at Licking Memorial Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
kkeck@lmhealth.org |
|
| |
Springfield |
|
| | | Springfield Regional Cancer Center |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
vmaggard@gradyhospital.com |
|
| |
Zanesville |
|
| | | Genesis - Good Samaritan Hospital |
| | | J. Philip Kuebler, MD, PhD | |
| | Email:
wlong@genesishcs.org |
|
| Texas |
|
| |
Temple |
|
| | | | CCOP - Scott and White Hospital |
| | | Lucas Wong, MD | |
| | Email:
dglover@swmail.sw.org |
| | | Scott and White Cancer Institute |
| | | Lucas Wong, MD | |
| | Email:
dglover@swmail.sw.org |
|
| Washington |
|
| |
Puyallup |
|
| | | | Rainier Physicians - NWMS |
| | | Lauren Colman, MD | |
| | Email:
dprentice@rainieroncology.com |
|
| |
Tacoma |
|
| | | CCOP - Northwest |
| | | Lauren Colman, MD | |
| | Email:
karyn.hart@multicare.org |
|
| Puerto Rico |
|
| |
Ponce |
|
| | | | Andres Grillasca Hospital |
| | | Luis Baez-Diaz, MD, FACP | |
| | Email:
sjccop@prtc.net |
|
| |
San Juan |
|
| | | Hato Rey Hematology/Oncology Group, PSC |
| | | Luis Baez-Diaz, MD, FACP | |
| | Email:
sjccop@prtc.net |
| | | I. Gonzalez Martinez Oncologic Hospital |
| | | Luis Baez-Diaz, MD, FACP | |
| | Email:
sjccop@prtc.net |
| | | San Juan City Hospital |
| | | Luis Baez-Diaz, MD, FACP | |
| | Email:
sjccop@prtc.net |
| | | Veterans Affairs Medical Center - San Juan |
| | | Luis Baez-Diaz, MD, FACP | |
| | Email:
sjccop@prtc.net |
|
Related Information Featured trial article
| Registry Information | | | Official Title | | Stress Management Therapy for Patients Undergoing Chemotherapy | | | Trial Start Date | | 2006-12-15 | | | Trial Completion Date | | 2012-06-15 (estimated) | | | Registered in ClinicalTrials.gov | | NCT00377130 | | | Date Submitted to PDQ | | 2006-05-01 | | | Information Last Verified | | 2009-07-01 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
|
